We are a leading provider of professional services for the registration of medical devices in India, specializing in compliance with Central Drugs Standard Control Organization (CDSCO) regulations.
The MD-15 license is mandatory for the registration of imported medical devices under the Central Drugs Standard Control Organization (CDSCO) in India. It ensures your device meets Indian safety and quality standards before entering the market.
Who Needs the MD-15 License?
Importers bringing medical devices into India
Foreign manufacturers marketing devices in India via an authorized importer or representative
Eligibility Criteria
Importer must be a registered legal entity in India with a valid State Drug License
Manufacturer must be authorized by their country’s regulatory authority
Devices must comply with Indian or internationally recognized standards (e.g., ISO, CE)
Foreign companies must appoint an authorized Indian representative
Required Documents
Completed MD-15 Application Form
Importer’s valid Drug License
Manufacturer’s license from the country of origin
Free Sale Certificate (FSC) from the country of origin
Good Manufacturing Practice (GMP) Certificate
Clinical data for high-risk devices (if applicable)
Product specifications and labeling samples
Test reports from accredited labs
Import invoice and certificate of compliance
Application Process
Submit Application online via CDSCO portal with all documents
CDSCO Review including technical evaluation for high-risk devices
Inspection of manufacturing sites (if necessary)
Pay Fees according to device risk class
License issuance is valid for 5 years
Post-Market Surveillance compliance required after approval
Fees & Validity
Fees vary by device risk class:
Class A (low risk) – lower fees
Class B (moderate risk) – moderate fees
Class C & D (high risk) – higher fees with stricter scrutiny
License valid for 5 years, with renewal required before expiry
Timeline
Typical processing: 180 to 270 days
High-risk devices may take longer due to additional checks
Compliance Highlights
Devices must meet Indian Medical Device Rules, 2017
Proper labeling and packaging as per Indian regulations
Mandatory reporting of adverse events or device failures
Key Tips
High-risk devices (Class C & D) need detailed clinical evidence
Maintain all documentation to avoid delays
Stay updated with CDSCO guidelines for any regulatory changes
By following these steps and meeting CDSCO requirements, you can successfully register your imported medical device with the MD-15 license and enter the Indian market with confidence.
Understanding CDSCO Registration for Medical Devices & Drugs in South India
Entering the Indian medical market requires strict compliance with CDSCO regulations. For companies, dealers, and distributors in Kerala, Karnataka, Tamil Nadu, Telangana, and Andhra Pradesh, obtaining the proper licenses for medical devices, IVDs, drugs, and cosmetics is essential to ensure legal operations and market trust.
At Lumbar HealthTech, we provide end-to-end support for CDSCO registration, including documentation, submission, and follow-up with authorities. Our goal is to make the process smooth, quick, and hassle-free for manufacturers, dealers, and distributors across South India.
Why Dealers & Distributors in South India Should Partner with Us
Access to a comprehensive product range
Guidance on regulatory compliance and documentation
Timely updates on new products and approvals
Efficient order and logistics support
CDSCO Registration for Medical Devices & Drugs – PAN India
Entering the Indian medical market requires strict compliance with CDSCO regulations. For companies, dealers, and distributors across India, obtaining the proper licenses for medical devices, IVDs, drugs, and cosmetics is essential to ensure legal operations and market trust.
At Lumbar HealthTech, we provide end-to-end CDSCO registration services, including documentation, submission, and follow-up with authorities. Our goal is to make the process smooth, fast, and hassle-free for manufacturers, dealers, and distributors nationwide.
Why Dealers & Distributors Across India Should Partner with Us
Access to a comprehensive product range
Expert guidance on regulatory compliance and documentation
Timely updates on new product approvals and launches
Efficient order and logistics support
By partnering with Lumbar HealthTech, dealers and distributors all over India can expand their product offerings, stay compliant with regulations, and focus on growing their business without regulatory hurdles.
The MD-15 Retention License is essential for medical device manufacturers to continue legally manufacturing and selling their products in India. It renews your existing CDSCO registration to ensure uninterrupted market access.
Key Highlights:
Purpose: Retain and renew medical device registration for ongoing import or manufacture in India.
When to Apply: 3 to 6 months before current license expiry.
Who Needs It: Registered manufacturers with valid CDSCO licenses across all device classes (A, B, C, D).
Required Documents:
Online Application via CDSCO Sugam Portal
Existing Manufacturing/Import License
Valid GMP Certificate (ISO 13485 or equivalent)
Detailed Product Information (specs, clinical data)
Authorization Letter (if applicable)
Renewal Fee payment
Application & Approval Process:
Submit application online with documents and fees.
CDSCO reviews and may request clarifications.
Upon approval, license renewed—typically valid for 5 years.
Post-Retention Compliance:
Ongoing product surveillance
Adverse event reporting
Maintaining GMP certification
Periodic audits
MD-15 Endorsement Process
The MD-15 Endorsement is required to update or modify your existing MD-15 license after changes in product details, manufacturing, labeling, or import details.
When Is Endorsement Needed?
Changes in manufacturer or importer details
Modifications in device design, use, or specifications
Updates to GMP or quality management systems
Changes in product labeling, packaging, or new variants
Documents Required:
Endorsement Application Form (via CDSCO Sugam Portal)
Updated Manufacturer and Product Information
Latest GMP & QMS Certifications
Authorization Letter (if applicable)
Updated Labeling/Packaging Samples
Supporting Data (clinical, testing reports, if applicable)
Endorsement Process:
Upload all required documents and submit application online.
CDSCO reviews changes and may seek further information.
On approval, the endorsement is issued reflecting the updated details.
After Endorsement:
Ensure all labeling and packaging comply with new approval.
Maintain post-market surveillance and adverse event reporting.
Continue compliance with CDSCO regulations and certifications.
Important Tips for Both Processes
Apply early: Start renewal or endorsement before current license expiration to avoid delays.
Complete documentation: Missing or incorrect documents can cause processing delays.
Keep local agents informed: Foreign manufacturers must coordinate closely with their authorized Indian representatives.
Stay compliant: Regularly update GMP certifications and report safety issues promptly.
Conclusion
The MD-15 Retention and Endorsement processes are critical to maintaining the legal and regulatory status of your medical devices in India. By following the proper steps and keeping your documentation up-to-date, you ensure uninterrupted market presence and compliance with CDSCO regulations.
The In-vitro Diagnostic (IVD) device registration process in India is governed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules, 2017, which regulates medical devices, including IVDs. The process ensures that IVDs imported or manufactured in India comply with safety, quality, and performance standards before they are marketed.
Here is a detailed overview of the IVD registration process in India:
1. Classification of IVD Devices
IVDs are classified into different categories based on their risk level. The classification determines the regulatory requirements, including testing, documentation, and fees.
Class A: Low risk (e.g., simple reagents or diagnostic kits for glucose testing).
Class B: Moderate risk (e.g., diagnostic kits for HIV, Hepatitis).
Class C: High risk (e.g., blood glucose meters, diagnostic devices for high-risk diseases).
Class D: Very high risk (e.g., diagnostic devices used for critical conditions, cancer detection kits).
2. Eligibility Criteria for IVD Registration
The following conditions must be met to be eligible for IVD registration:
Importer: The applicant must be a legal entity registered in India (e.g., a company, firm, etc.) and must hold a valid drug license issued by the State Licensing Authority for dealing with medical devices.
Manufacturer: The manufacturer of the IVD device must be authorized by the relevant regulatory authority in the country of origin.
Authorized Representative: If the importer is a foreign company, they must appoint an authorized representative in India to handle the registration and other regulatory requirements.
3. Documents Required for IVD Registration
The following documents must be submitted for IVD registration:
1) Application Form (MD-12): A completed form MD-12 is required for the registration of the medical device, which includes IVD devices.
2) Importer’s Drug License: A copy of the valid drug license issued by the State Licensing Authority for medical devices.
3) Manufacturing License: A copy of the manufacturer's license issued by the regulatory authority in the country of origin.
4) Free Sale Certificate (FSC): A certificate from the relevant regulatory authority in the country of origin that confirms the product is freely sold in that country.
5) Good Manufacturing Practice (GMP) Certificate: For the manufacturing facility, confirming compliance with GMP standards for the production of medical devices.
Certificate of Pharmaceutical Product (CPP): If applicable, confirming that the device complies with relevant product standards in the country of origin.
Product Information: Detailed description of the IVD device, including its intended use, specifications, and design.
Clinical Trial Data: Clinical or analytical data demonstrating the safety and performance of the device, especially for high-risk devices (Class C or D).
Test Reports: Test reports from recognized labs showing that the IVD device complies with applicable standards (e.g., safety, efficacy, biocompatibility).
Labeling and Packaging: Samples of labeling and packaging, including instructions for use, warnings, and safety information in compliance with Indian regulations.
Proforma Invoice: A proforma or commercial invoice indicating the quantity, description, and price of the IVD device.
Import Invoice: An invoice from the manufacturer or supplier of the IVD device.
4. Application Process for IVD Registration
The process for registering an IVD device involves the following steps:
Step 1: Complete and Submit the Application
Form MD-12 must be filled out completely and signed by the authorized person (typically the applicant or the authorized representative in India).
Submit the required documents along with Form MD-12 to CDSCO via the CDSCO e-portal or through the relevant CDSCO regional office (depending on the location).
Step 2: Document Review by CDSCO
CDSCO reviews the submitted application and supporting documents. If the documents are complete and meet the regulatory standards, the CDSCO may process the application.
The CDSCO may consult with the Medical Devices Technical Advisory Board (MDTAB) for certain high-risk IVD devices (Class C and D), especially if clinical trials or additional technical data are required.
Step 3: Inspection (If Applicable)
For high-risk IVDs (Class C and D), CDSCO may require an inspection of the manufacturing facility or request additional clinical investigation data or testing results.
Step 4: Fee Payment
The registration process involves the payment of a prescribed fee, which varies depending on the classification of the IVD device. Payment details will be provided by CDSCO based on the class and type of the IVD.
Step 5: Issuance of Registration Certificate
Once the application is approved, CDSCO will issue an IVD Registration Certificate. This certificate authorizes the sale and distribution of the IVD in India.
The registration certificate is typically valid for 5 years, after which it needs to be renewed.
Step 6: Post-Market Surveillance
After the device is registered, the importer must ensure that they conduct post-market surveillance to monitor the safety and effectiveness of the IVD in the Indian market.
Any adverse events, product failures, or recalls must be reported to CDSCO in accordance with Indian regulations.
5. Fees for IVD Registration
The fees for IVD registration depend on the risk classification of the device:
Class A devices (low risk): Relatively lower registration fees.
Class B devices (moderate risk): Moderate registration fees.
Class C devices (high risk): Higher fees due to the complexity of the device and additional documentation requirements.
Class D devices (very high risk): The highest fees, as these devices require more extensive data and testing.
The exact fee structure is published on the CDSCO website and can vary periodically.
6. Validity and Renewal
Validity: The IVD registration is valid for 5 years.
Renewal: The registration must be renewed before the expiry date by submitting a renewal application and any required updated documentation. The renewal process is similar to the original registration process.
7. IVD Registration Timeline
The processing time for registering an IVD device typically ranges from 30 to 90 days. However, this timeline can vary based on the class of the device, completeness of documentation, additional data requirements (e.g., clinical trials), and regulatory review processes. High-risk IVDs may take longer to process due to more stringent evaluation requirements.
8. Post-Registration Compliance
Once the IVD is registered and marketed in India, the following obligations apply:
Post-Market Surveillance: The importer is responsible for monitoring the performance and safety of the IVD and reporting any adverse events to CDSCO.
Labeling Compliance: The IVD device must adhere to Indian labeling standards, including language requirements (labels must be in English and Hindi).
Quality Control: The importer must ensure that the IVD is consistently manufactured according to the registered specifications and quality standards.
9. Key Regulatory Authorities Involved
Central Drugs Standard Control Organization (CDSCO): The primary authority for the regulation of medical devices in India.
Drug Controller General of India (DCGI): The head of CDSCO responsible for overseeing the regulation of medical devices, including IVDs.
State Licensing Authorities: State-level authorities issue licenses for the import, manufacture, and sale of medical devices.
10. Key Points to Remember
Class C and D IVDs are subject to more stringent regulatory requirements, including clinical trials, additional documentation, and detailed evaluation.
Ensure that the IVD device complies with Indian regulations and standards (e.g., ISO, ISI, or other recognized quality standards).
Adverse event reporting and post-market surveillance are critical components of maintaining the safety and effectiveness of the IVD device in the Indian market.
By following the above steps and ensuring all documentation and regulatory requirements are met, you can successfully register an In-vitro Diagnostic device in India with CDSCO. Always ensure compliance with the Medical Device Rules, 2017, and stay updated with any changes to regulations from CDSCO.
The CDSCO (Central Drugs Standard Control Organization) Manufacturing License is required for companies wishing to manufacture medical devices or drugs in India. The Manufacturing License ensures that the manufacturer complies with the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017 (for medical devices), guaranteeing that the products are safe, effective, and of the required quality standards.
Here’s a detailed overview of the
CDSCO manufacturing license process for medical devices and drugs:
1. Types of Manufacturing Licenses under CDSCO
CDSCO issues two main types of manufacturing licenses based on the type of products:
Drug Manufacturing License: For the manufacture of pharmaceutical products.
Medical Device / IVD Manufacturing License:
For the manufacture of medical devices and IVD (in-vitro diagnostic) devices.
Both licenses are issued by CDSCO under the guidance of the Drug Controller General of India (DCGI).
2. Eligibility for CDSCO Manufacturing License
The applicant must meet the following criteria:
Legal Entity: The manufacturer must be a registered entity under Indian laws (e.g., a company, partnership firm, etc.).
GMP Compliance: The manufacturing facility must comply with Good Manufacturing Practices (GMP), which are standards for the production of medical devices and drugs.
Licensing Authority: The applicant must hold a valid State Licensing Authority (SLA) License for medical devices or pharmaceutical products, as well as any other necessary documents.
Qualified Personnel: The facility should have qualified personnel, including a Qualified Person (QP) for manufacturing.
3. Documents Required for CDSCO Manufacturing License
The following documents are required to apply for a manufacturing license:
Application Form:
Form 28 for the manufacture of medical devices.
Form 24D for the manufacture of pharmaceutical drugs.
Manufacturing Premises:
Layout plan of the manufacturing premises showing details of the machinery, storage areas, and production facilities.
List of equipment and machinery used for manufacturing.
Good Manufacturing Practice (GMP) Certificate:
The manufacturer must provide proof of compliance with GMP. This includes a GMP certificate issued by the relevant authority.
Free Sale Certificate (FSC):
A Free Sale Certificate from the regulatory authority in the country of origin, verifying that the product is freely sold and marketed there.
Certificate of Pharmaceutical Product (CPP):
For drugs, a Certificate of Pharmaceutical Product (CPP) from the country of origin confirming that the product is registered and available for sale.
Manufacturer’s License:
A copy of the manufacturer's license issued by the competent authority of the country where the medical device or drug is being manufactured.
Qualified Person (QP):
Qualification details of the Qualified Person (such as educational qualifications and work experience) who will be responsible for manufacturing oversight.
Stability Data (if applicable):
Stability testing data of the product(s) manufactured to show compliance with product quality standards.
Details of Manufacturing Process:
A detailed description of the manufacturing process, including a list of raw materials, specifications, and procedures.
Proof of Ownership:
Ownership or Lease Agreement for the manufacturing premises, indicating legal control over the facility.
Test Reports:
Reports for the device or drug, proving its safety and efficacy, conducted by accredited testing laboratories.
Labeling and Packaging:
Samples of the labeling and packaging used for the products, including instructions for use and safety information, in compliance with Indian regulatory standards.
4. Application Process for CDSCO Manufacturing License
The process for obtaining a CDSCO manufacturing license involves several steps:
Step 1: Application Submission
The applicant (manufacturer) must complete the relevant application form (Form 28 for medical devices or Form 24D for pharmaceutical drugs) and submit it along with the required documents to the CDSCO.
Step 2: Application Review by CDSCO
CDSCO will review the submitted application and documents. This may involve technical evaluation, inspections, and verification of compliance with regulatory standards.
The regional CDSCO office may consult with experts, especially for high-risk medical devices or new drug formulations, before issuing the license.
Step 3: Facility Inspection (If Applicable)
CDSCO may conduct an inspection of the manufacturing facility to ensure that it complies with Good Manufacturing Practices (GMP) and that the facility meets the required safety standards. The inspection ensures that the premises, equipment, and processes meet the quality requirements for medical devices or drugs.
If the manufacturing process is located outside India, CDSCO may require inspections at the foreign facility or request additional evidence of compliance.
Step 4: License Issuance
Once the application is approved and the inspection (if required) is successful, CDSCO will issue the manufacturing license.
The license will specify the types of products that the manufacturer is authorized to produce.
Step 5: Fee Payment
The application process includes the payment of registration or license fees. The amount depends on the type and class of the product being manufactured (higher fees may apply to high-risk medical devices).
5. Fees for Manufacturing License
The fees for the manufacturing license depend on the product type (medical devices, drugs) and risk classification (e.g., Class A, B, C, D for medical devices).
For medical devices, Class A (low risk) will have lower fees than Class C or Class D (high risk).
The exact fees for a manufacturing license can be found on the CDSCO website or by contacting the CDSCO office.
6. Validity and Renewal of Manufacturing License
Validity: The CDSCO manufacturing license is generally valid for 5 years.
Renewal: Manufacturers need to apply for renewal of the manufacturing license before it expires by submitting an application and updated documentation. Failure to renew on time may lead to suspension or cancellation of the license.
7. Timeline for Manufacturing License Approval
The processing time for obtaining a CDSCO manufacturing license typically ranges from 30 to 180 days, depending on the type of product, completeness of documentation, and the regulatory review process. High-risk products (such as Class C or D medical devices) may take longer due to additional evaluation and inspections.
8. Post-License Obligations
Once the manufacturing license is obtained, the manufacturer must adhere to several obligations:
Quality Control: The manufacturer must ensure that their production complies with Good Manufacturing Practices (GMP).
Adverse Event Reporting: The manufacturer must report any adverse events or product recalls to CDSCO, particularly for medical devices.
Post-Market Surveillance: Ongoing monitoring of the safety and performance of the product in the market is required, especially for high-risk medical devices.
Regulatory Compliance: The manufacturer must maintain compliance with the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017.
9. Key Regulatory Authorities Involved
CDSCO (Central Drugs Standard Control Organization): The primary authority for regulating the manufacturing of medical devices and drugs in India.
DCGI (Drug Controller General of India): The head of CDSCO responsible for overseeing licensing, regulation, and inspection.
State Licensing Authorities: State-level authorities issue licenses for the manufacturing and distribution of drugs and medical devices.
10. Key Points to Remember
Manufacturers of medical devices and drugs in India must comply with GMP, labeling, packaging, and regulatory standards as defined under Indian laws.
The manufacturing license must be renewed every 5 years, and the manufacturer must maintain compliance with all relevant standards.
The post-market surveillance process is essential for the ongoing monitoring of safety and efficacy in the market.
By following the above steps and ensuring all regulatory requirements are met, you can successfully obtain a CDSCO manufacturing license for medical devices or drugs.
The CDSCO (Central Drugs Standard Control Organization) License is an official authorization provided by the Government of India for the manufacture, sale, import, and distribution of drugs, medicines, and medical devices in India. CDSCO regulates medical devices, in-vitro diagnostic devices (IVDs), and pharmaceuticals, ensuring they comply with standards of safety, quality, and efficacy under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017.
Here is an overview of the various types of licenses issued by CDSCO, their details, and the processes involved:
1. Types of CDSCO Licenses
There are several types of CDSCO licenses, depending on the business activities involved (e.g., manufacturing, importing, distribution) and the type of product (drugs, medical devices, etc.):
1.1. Manufacturing License (Drugs and Medical Devices)
For Pharmaceutical Products: License for the manufacture of drugs, including active pharmaceutical ingredients (APIs), dosage forms (tablets, injections, etc.), and vaccines.
For Medical Devices: License to manufacture medical devices (Class A, B, C, or D) and in-vitro diagnostic (IVD) devices.
Application Form:
Form 28 (for medical devices).
Form 24D (for drugs).
1.2. Import License (Drugs and Medical Devices)
For Importers: Any entity wishing to import medical devices, IVDs, or pharmaceutical products into India must obtain an import license from CDSCO.
For medical devices/IVDs: Importers must register their products before importation.
Application Form:
Form 40 (for drugs and pharmaceutical products).
Form MD-14 (for medical devices).
1.3. Wholesale and Retail License
For Wholesale Distribution: To distribute drugs and medical devices at the wholesale level within India, entities must obtain a wholesale license from CDSCO.
For Retail Sale: Retailers of pharmaceutical products and medical devices also need to obtain licenses for retail sale.
Application Form:
Form 19 (wholesale license for drugs).
Form 21 (retail sale license).
1.4. Registration License for Medical Devices
For Medical Devices: Manufacturers or importers of medical devices (including IVDs) must register the device with CDSCO before it is marketed in India.
Application Form:
MD-14 (for medical devices and IVD registration).
1.5. Clinical Trial Permission
For conducting clinical trials involving drugs or medical devices, entities must obtain permission from CDSCO before initiating trials.
Application Form:
Form CT-01 for clinical trial applications (for drugs).
2. Eligibility for CDSCO Licenses
To apply for any CDSCO license, the applicant must meet the following criteria:
Legal Entity: The applicant must be a registered company, partnership, or firm under Indian law (e.g., Company Act, Partnership Act).
Compliance with Regulatory Standards: The applicant must meet the relevant Good Manufacturing Practices (GMP) for medical devices or drugs.
Qualified Personnel: The applicant must employ qualified personnel (such as a qualified person (QP) for manufacturing).
Facility Standards: The manufacturing facility must meet the required infrastructure and quality control measures as per the Drugs and Cosmetics Act, Medical Devices Rules, and relevant standards.
State License: For manufacturing, sale, or distribution of drugs and devices in India, a State Licensing Authority (SLA) license is also required (state-level license).
3. CDSCO License Application Process
The process for obtaining a CDSCO license (for manufacturing, importing, etc.) follows these general steps:
Step 1: Complete the Application Form
The applicant must complete the appropriate application form depending on the license type (e.g., Form 28 for medical devices manufacturing, Form 40 for importers).
Step 2: Submit Required Documents
The following documents are generally required for the application:
Application Form (as mentioned above).
Manufacturing License/Import License from the State Licensing Authority (if applicable).
GMP Certificate (for manufacturing).
Free Sale Certificate (FSC) from the country of origin (for imported drugs or medical devices).
Certificate of Pharmaceutical Product (CPP) (for pharmaceutical products).
Test Reports from accredited labs.
Clinical Trial Data (if applicable).
Product Details (including technical specifications, intended use, labeling, and packaging details).
Stability Data (for drug products).
Step 3: Submission to CDSCO
The completed application and documents are submitted to CDSCO through its online portal or regional offices, depending on the product category.
Step 4: Application Review
CDSCO reviews the application and supporting documents to ensure compliance with Drugs and Cosmetics Act and Medical Devices Rules.
CDSCO may consult with technical advisory boards (e.g., MDTAB for medical devices) for additional information or clarification.
Step 5: Inspection (If Applicable)
For manufacturing licenses, CDSCO may inspect the manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP).
For high-risk medical devices or IVDs, additional inspections may be required at the manufacturer’s site.
Step 6: License Issuance
After successful review and approval of the application, CDSCO issues the license (manufacturing, import, distribution, etc.).
The license specifies the scope of authorization (e.g., product types, geographical limits) and is valid for a specific period (usually 5 years for manufacturing licenses).
Step 7: License Renewal
CDSCO licenses need to be renewed periodically (every 5 years for manufacturing licenses). Renewal requires submission of updated documents and a renewal application before the expiry date.
4. Fees for CDSCO Licenses
The fees for obtaining a CDSCO license vary based on the type of license, product category, and classification (e.g., Class A, B, C, D for medical devices). The exact fee structure is typically outlined on the CDSCO website or can be obtained by contacting CDSCO directly.
Manufacturing License Fees: Higher for high-risk products like Class C and D medical devices, compared to low-risk devices.
Import License Fees: Varies depending on the product type.
Renewal Fees: Fees are charged at the time of license renewal.
5. Validity and Renewal of CDSCO Licenses
Manufacturing License: Valid for 5 years; it needs to be renewed before the expiration date by submitting a renewal application and updated documents.
Import License: Valid for 5 years and renewable after that period.
Other Licenses (Retail/Wholesale): Typically valid for 5 years and must be renewed on time.
6. Post-License Obligations
After obtaining a CDSCO license, the licensee must:
Comply with GMP standards for manufacturing.
Maintain proper records of production, sales, and distribution.
Conduct post-market surveillance for medical devices or drugs to monitor safety and performance.
Report adverse events or product issues to CDSCO.
Renew the license as per regulatory timelines.
7. Timeline for CDSCO License Issuance
The time required for obtaining a CDSCO license depends on the type of product and license applied for:
Manufacturing License: Typically takes 90 to 180 days for approval (especially for high-risk medical devices).
Import License: Typically 180 to 270 days depending on the product.
Registration License for Medical Devices: Around 180 days, but may take longer for high-risk devices.
8. Key Regulatory Authorities Involved
CDSCO (Central Drugs Standard Control Organization): The primary authority for granting manufacturing, import, and distribution licenses for drugs and medical devices.
Drug Controller General of India (DCGI): Head of CDSCO, responsible for overseeing the approval process.
State Licensing Authorities (SLA): Issue state-level licenses for the manufacture, sale, and distribution of drugs and devices.
By following these processes and ensuring compliance with Indian regulations, you can successfully obtain a CDSCO license for manufacturing, importing, or distributing drugs and medical devices in India.
Benefits of Appointing Lumbar Healthtech as Your Authorized Indian Agent
Appointing Lumbar Healthtech as your Indian Authorized Agent provides clarity, confidence, and control over your import, distribution, and vigilance activities in India. Here's why choosing us as your agent is an advantageous move for your business:
Key Benefits
1) Direct Sales to Multiple Regional Distributors
Bypassing National Importers: We allow you to sell directly to multiple regional distributors, avoiding the mark-up typically added by national importers. This maximizes your margins and keeps the process efficient.
2) Improved Transfer Pricing
No Registration Cost Burden for Distributors: Since we handle the registration process, distributors are not burdened with registration costs, enabling more favorable transfer pricing.
3) Better Leverage in Distributor Negotiations
Strengthened Position: Having an Authorized Indian Agent provides you with better leverage in negotiations with distributors and partners due to your direct involvement in the regulatory process.
4) Flexibility to Add or Change Distributors
Dynamic Partnerships: As your local agent, we offer the flexibility to adjust your distribution network, allowing you to change distributors as required without affecting your regulatory standing.
5) Protection of Intellectual Property
Safeguarding Sensitive Information: By working with Lumbar Healthtech, you avoid exposing sensitive technical files and intellectual property to local commercial agents, reducing the risk of misuse or leakage.
Our Services as Your Authorized Agent
Lumbar Healthtech offers comprehensive support for the importation and distribution of medical devices in India, including:
Shipment Handling: We take title of the shipment, ensuring smooth customs clearance and local distribution.
Order and Payment Processing: We manage all aspects of order fulfillment, payment processing, and shipping arrangements.
Shipping and Customs Clearance: We handle Ex-works shipping and provide full support for customs clearance in India.
Local Delivery: We coordinate local delivery to regional distributors' warehouses to ensure timely access to your products.
Optional Support Services:
Additional services include long-term storage, break-bulk, labelling, and order fulfillment upon client request.
Steps for CDSCO Registration of Medical Devices
Navigating the regulatory landscape can be complex, but with Lumbar Healthtech as your Indian Authorized Agent, you’ll be guided through the following steps for CDSCO registration with ease:
1) Determine Device Classification
Classify Your Device: The first step is to determine whether your medical device is classified as Class A, Class B, Class C, or Class D. Class A devices are low-risk, while Class D devices are high-risk and subject to stricter controls.
2) Appoint an Authorized Indian Representative
Designation of an Authorized Agent: If you are a foreign manufacturer, appointing a local authorized representative (like Lumbar Healthtech) is mandatory. We act as your representative to liaise with the Central Drugs Standard Control Organization (CDSCO).
3) Prepare Required Documentation
Gather Documentation: Prepare technical documents, clinical data, Good Manufacturing Practices (GMP) certificates, Quality Management System (QMS) certifications, and any other relevant documents required by CDSCO.
4) Submit Application Online
CDSCO Sugam Portal: Use the Sugam Portal to electronically submit your application for medical device registration. This portal simplifies the registration process, making it more efficient.
5) Pay the Required Fees
Fees Based on Classification: The registration fee depends on the classification of the medical device. Class A devices have a lower fee compared to higher-risk devices (Class C and D).
6) Review and Approval
CDSCO Review: CDSCO will review your submission and, if necessary, request further clarification or additional documents. We will assist in ensuring your application is complete and accurate.
7) Obtain Registration Certificate
Receive Approval: Upon successful approval, CDSCO issues the device registration certificate, allowing you to legally import and market your product in India.
Process for Importing Medical Devices into India (Including Class A Devices)
1) Device Classification
The first step is to determine the risk category of the device, as specified in the Medical Device Rules, 2017. For Class A devices (low-risk), the regulatory requirements are relatively simpler compared to higher-risk devices (Class B, C, D).
2) Manufacturer Registration
Foreign manufacturers must register their manufacturing facility with CDSCO, submitting relevant documents, including proof of Good Manufacturing Practices (GMP) compliance.
3) Appointment of Indian Agent
Foreign manufacturers must appoint an Indian Authorized Agent (like Lumbar Healthtech) who will be responsible for regulatory liaison and communication with CDSCO.
4) Application for Import License
The Indian agent submits an application for an import license, which includes:
Device details (technical specifications, intended use, etc.)
Importer’s license or registration certificate (if applicable)
Manufacturer's authorization letter
Quality management system certificate
GMP certificate (if applicable)
5) Import License Approval
Once the application is reviewed and approved by CDSCO, an import license is granted, specifying the conditions for importing the device into India.
Post-Importation Compliance
Post-market obligations include:
Labeling compliance
Market surveillance
Adverse event reporting
Product renewals
Important Notes
Authorized Agent Role: Your authorized agent plays a pivotal role in liaising with CDSCO on your behalf, ensuring that all regulatory requirements are met at each step of the process.
Regulatory Compliance: Continuous compliance with the Medical Device Rules and CDSCO regulations is mandatory for all foreign manufacturers wishing to sell medical devices in India.
CDSCO Guidance: It’s highly advisable to consult with a regulatory expert or legal advisor familiar with CDSCO rules to navigate the process smoothly and avoid potential setbacks.
By partnering with Lumbar Healthtech, you can significantly simplify the importation and registration process for your medical devices in India, ensuring timely market entry, regulatory compliance, and continued support throughout your product’s lifecycle.
Contact us today to get started!
FOR IMPORTER TO INDIA
We provide complete Regulatory and Licensing Solutions for Importers, Authorized Agents, and Overseas Manufacturers to import Drugs, Medical Devices, IVDs, and Cosmetics into India under CDSCO and related authorities.
💊 Drugs
We assist in end-to-end regulatory support and compliance for drug importation and marketing in India.
Services Include:
Post Approval Changes for Drug
Test License to Import Drugs in India
Authorized Agent in India for Drug Import
Wholesale License (Form 20B)
Regulatory Services for Drug License
Drug Marketing Authorization Approval in India
Drug Registration Certificate
Drug Re-registration (Form 40)
Permission for Repacking (Under Rule 37)
Import License (Form 10 & 11)
Advanced Shelf Life Extension
🏥 Medical Devices
We offer expert guidance for medical device importers and overseas manufacturers to comply with Indian regulatory requirements under CDSCO (Medical Device Rules, 2017).
Services Include:
Authorized Agent in India for Medical Device
Import License (Form MD-14, MD-15)
New Medical Device Permission (Form MD-26, MD-27)
Registration Number for Non-Notified Medical Devices
Clarification Letter from CDSCO
Permission to Conduct Clinical Investigation (Form MD-22, MD-23)
Post Approval Changes (Major / Minor)
PC & PNDT Certificate (for Imaging / Diagnostic Equipment)
Assistance in ISO 13485 Certification
Label Compliance (As per MDR, 2017)
WPC – ETA Approval
WPC Framework for Wireless Medical Devices
Permission to Import Medical Devices for Test License
Sugam Registration for Medical Devices
New Medical device license for Manufacturing (Form MD-26, MD-27)
Registration for Class A (Non-Sterile & Non-Measuring Devices)
EPR Authorization Certificate from CPCB
E-Waste EPR Registration & Post-Compliance Support
🧪 In-Vitro Diagnostics (IVD)
We provide regulatory support for IVD importers and overseas manufacturers under CDSCO licensing norms.
Services Include:
Authorized Agent in India for IVD Import (Form MD-14, MD-15)
Import License (Form MD-14, MD-15)
Registration Number for Non-Notified IVDs
Label Compliance for IVDs
Free Sale Certificate Support
Test License to Import In-Vitro Diagnostics
Permission to Conduct Clinical Performance Evaluation (Form MD-24, MD-25)
Assistance in ISO 13485 Certification
Clarification Letter / No Objection Certificate
Post Approval Changes (Major / Minor)
Retention of IVD Import License
Permission for Import of Predicate IVD Kits (Form MD-14, MD-15)
💅 Cosmetics
We offer full regulatory assistance to importers and authorized agents for cosmetic products under CDSCO Cosmetic Rules, 2020.
Services Include:
Authorized Agent in India for Cosmetics
Permission to Import / Manufacture New Cosmetics in India
Fresh Cosmetic Registration (Form COS-2)
Cosmetic Product Compliance (Label, Ingredient & Safety Review)
Post Approval Changes for Cosmetics
For MANUFACTURERS IN INDIA
Drug Manufacturing Services
Test License to Manufacture Drugs in India
New Drug Approval (Form 44 Submission & Evaluation)
Wholesale Drug License (Form 20B & 21B)
Permission to Manufacture Formulations using Unapproved API Drugs
Manufacturing License for Drugs (Form 25, 28)
Investigational New Drug (IND) Application Support
Subsequent New Drug Approval (SND)
Permission to Manufacture Unapproved API for Formulation Development / Testing / CT / BA / BE Studies (CT-15)
Pharmaceutical Quality & Regulatory Compliance Services
Good Manufacturing Practices (GMP) Implementation & Certification
Medical Device Manufacturing Services
Permission to Manufacture Class B Medical Devices (Form MD-3, MD-5)
Permission to Manufacture Class C & D Medical Devices (Form MD-7, MD-9)
New Medical Device Permission (Form MD-26, MD-27)
Registration for Non-Notified Medical Devices
Permission to Conduct Clinical Investigation (Form MD-22, MD-23)
Post-Approval Changes (Major / Minor) Handling
Pre-Conception & Pre-Natal Diagnostic Techniques (PCPNDT) Certificate Assistance
Assistance in ISO 13485 Certification
Label Compliance for Medical Devices
WPC - ETA Approval for Wireless Devices
Test License to Manufacture Medical Devices (Form MD-12, MD-13)
Comprehensive Medical Device Manufacturing Support Services
Registration for Class A Non-Sterile and Non-Measuring Devices
Clarification Letter / No Objection Certificate (NOC)
Loan License to Manufacture Medical Devices (Class C & D)
Loan License to Manufacture Medical Devices (Class A & B)
Free Sale Certificate (FSC)
Sugam Portal Registration
Manufacturing License for Class A & B Devices
Manufacturing License for Class C & D Devices
New Medical Device License for Manufacturers
Retention of Loan License (Class C & D Devices)
Retention of Medical Device Manufacturing License (Class C & D)
WPC Framework Compliance for Wireless Medical Devices
EPR Authorization Certificate from CPCB
E-Waste EPR Registration & Post-Compliance Management
EU Regulatory Due Diligence for Medical Devices
In-Vitro Diagnostic (IVD) Manufacturing Services
Permission to Manufacture Class A & B IVDs (Form MD-3, MD-5)
Permission to Manufacture Class C & D IVDs (Form MD-7, MD-9)
Registration for Non-Notified In-Vitro Diagnostic Devices
Label Compliance for IVD Devices
Free Sale Certificate for IVD Products
Permission to Conduct Clinical Performance Evaluation (Form MD-24, MD-25)
Assistance in ISO 13485 Certification for IVD Manufacturers
Test License to Manufacture IVD Devices
In-Vitro Diagnostic Device Manufacturing License Support
Clarification Letter / NOC for IVD Manufacturers
Sugam Portal License for IVD Kits
Loan License to Manufacture IVD Kits
Predicate IVD Kit Loan License Support
Predicate IVD Manufacturing License (Form MD-3, MD-5)
Loan License to Manufacture IVD Kits (Class C & D)
IVD Class A & B Manufacturing License
IVD Class C & D Manufacturing License
New In-Vitro Diagnostic License for Manufacturers
Endorsement of Loan License for Predicate IVD Manufacturer (Form MD-8, MD-10)
Cosmetic Manufacturing Services
Cosmetic Manufacturing License (Form COS-8, COS-9)
Cosmetic Product Compliance & Label Review
Permission to Import / Manufacture New Cosmetic Products in India
We provide comprehensive support for product registration and compliance across key global markets, including:
✅ CDSCO – India (Central Drugs Standard Control Organization)
✅ FDA – USA (Food and Drug Administration)
✅ CE Marking – European Union
✅ TGA – Australia (Therapeutic Goods Administration)
✅ ANVISA – Brazil (Agência Nacional de Vigilância Sanitária)
✅ PMDA – Japan (Pharmaceuticals and Medical Devices Agency)
✅ SFDA – Saudi Arabia (Saudi Food & Drug Authority)
✅ MDR – European Union (Medical Device Regulation)
✅ Health Canada – Canada
✅ NMPA – China (National Medical Products Administration)
✅ KFDA – South Korea (Korea Food & Drug Administration)
✅ TFDA – Taiwan (Taiwan Food and Drug Administration)
✅ UAE – Ministry of Health & Prevention (MOHAP)
✅ CE Certificate of Free Sale
✅ Local Market Registration Support (Country-specific)
📊 Tailored services for Manufacturers, Importers, and Exporters.
📞 Contact us to simplify your global market entry.
Your Trusted Partner for Medical Device Certification in India
At Lumbar Healthtech, we specialize in providing professional services for the registration and import of Medical Devices, Medical Equipment, and In Vitro Diagnostic Kits (IVD) in India.
As a Certified Indian Authorized Agent, we help foreign manufacturers navigate the complexities of the Indian regulatory landscape, ensuring compliance with CDSCO (Central Drugs Standard Control Organization) requirements.
Our Mission
To offer a stable, reliable local platform for international companies seeking growth in the competitive Indian and Asian medical markets.
We ensure your products meet necessary certification standards, paving the way for your success.
Services We Offer
Medical Device Registration in India
Expert guidance through the entire CDSCO registration process for medical devices, medical equipment, and IVD kits.
Authorized Agent Services
We manage all regulatory affairs as your Indian Authorized Agent, streamlining your product import approvals.
Certification Consultation
Comprehensive support to obtain ISO, CE, and CDSCO certifications.
Local Representation & Compliance
Strong local presence to ensure your products comply with Indian regulations and maintain seamless communication with regulatory authorities.
Post-Market Support
Ongoing assistance with market surveillance, adverse event reporting, product renewals, and more.
Why Appoint Lumbar Healthtech?
Local Expertise
Ensuring full compliance with Indian laws and guidelines.
Streamlined Processes
Simplifying the CDSCO process and saving your valuable time.
Regulatory Liaison
Acting as your primary point of contact with CDSCO.
Documentation Management
Meticulous handling of all required paperwork, from preparation to submission.
Market Insights
Providing valuable guidance on market trends and regulatory expectations.
Compliance Assurance
Helping you maintain post-approval compliance.
Risk Mitigation
Minimizing the risk of non-compliance to protect your reputation.
Cost Efficiency
Avoiding delays, rejections, and penalties through our expertise.
Operational Independence
Supporting your business at a cost-effective price, while you retain full control.
Local Network
Established connections for quick and efficient issue resolution.
Post-Approval Support
We continue to assist you with:
Market surveillance
Product recalls
Adverse event reporting
Regulatory updates and compliance renewals
Expand Your Reach
Connect with multiple distributors through our network.
Protect sensitive technical files and intellectual property.
Ensure supply chain stability with ongoing compliance.
🌐 About the Founder
Sridharan Nagarajan – Founder, Lumbar Healthtech
“Simplifying Regulatory Licensing with Precision, Integrity, and Expertise.”
Expert Leadership in Medical Device Regulatory Licensing
Sridharan Nagarajan is the Founder of Lumbar Healthtech, a specialized healthcare consulting company focused on medical device regulatory licensing and global compliance solutions.
With over two decades of experience in healthcare regulation, documentation management, and business development, he has guided Lumbar Healthtech toward becoming a trusted name for regulatory approvals across India and international markets.
His vision is clear — to empower manufacturers and innovators with a smooth, compliant, and transparent licensing process.
Simplifying Complex Licensing Pathways
Under his leadership, Lumbar Healthtech provides comprehensive regulatory services including:
CDSCO Licensing and Product Registration (Forms MD-3, MD-5, MD-9, MD-14, MD-15)
Manufacturing and Import License Support for Class A to D Devices
Technical File / Dossier Preparation and Quality Compliance
International Licensing – CE, FDA, ISO 13485 Certification Assistance
Every project is handled with a focus on accuracy, timely submission, and minimal regulatory queries — ensuring clients achieve approvals with confidence and speed.
Trusted Partner for Manufacturers and Importers
Sridharan has positioned Lumbar Healthtech as a dependable partner for medical device manufacturers, importers, and distributors seeking regulatory success in India and abroad.
The company provides end-to-end support — from product classification and documentation to post-approval maintenance and renewals — ensuring full compliance with the latest CDSCO and global standards.
Ethics, Quality, and Commitment
He believes that true regulatory success is built on transparency, ethical practices, and a commitment to quality.
His leadership philosophy ensures that every client receives clear guidance, professional execution, and trusted results, strengthening Lumbar Healthtech’s reputation as a responsible and reliable regulatory service provider.
A Message from the Founder
“At Lumbar Healthtech, our mission is to simplify the regulatory journey for medical device companies — helping them obtain the right licenses efficiently, ethically, and in full compliance with national and global standards.”