CDSCO Medical Device Consultant in India
We provide comprehensive services for the registration of medical devices and equipment
Your Partner in Regulatory Compliance
Lumbar Healthtech CDSCO Consulting Services:
We are a leading provider of professional services for the registration of medical devices in India, specializing in compliance with the Central Drugs Standard Control Organization (CDSCO)
regulations.
An overview of CDSCO approval process for registration
REGULATORY REGISTRATION SERVICES
REGULATORY REGISTRATION SERVICES
REGULATORY REGISTRATION SERVICES
IVD Registration
- In India, import, manufacturing, sale and distribution of In Vitro Diagnostic Medical Devices are regulated as Drug under sub-clause (i) of clause (b) of section 3 and sub-clause (iv) of clause (b) of section 3 of Drugs and Cosmetic Act and Rules
- The requirements for grant of licence to Manufacture, Import, Clinical Performance, Sale and Distribution are prescribed in MDR-2017.
- In vitro diagnostic medical devices shall be classified on the basis of risk parameters as specified in Part II of the First Schedule, as under:
- Low risk - Class A;
- Low moderate risk- Class B;
- Moderate high risk- Class C;
- High risk- Class D.
- Classification list of In Vitro Diagnostic Medical Devices have been published on the website of the Central Drugs Standard Control Organization approved by CLA.
- The Central Licensing Authority shall be the competent authority for enforcement in matters relating to:
- Import of all Classes of In Vitro Diagnostic Medical Device
- Manufacture of Class C and Class D In Vitro Diagnostic Medical Devices
- Clinical Performance evaluation and approval of new in vitro diagnostic medical devices
- Co-ordination with the State Licensing Authorities
- The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement in matters relating to-
- Manufacture for sale or distribution of Class A or Class B In Vitro Diagnostic
Medical Devices Registration
- Sale, stock, exhibit or offer for sale or distribution of In Vitro Diagnostic Medical Devices of all classes.
- Medical Devices Registration
- In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945.
- substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
- (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
- devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940;
Name of the Medical Device
- Disposable Hypodermic Syringes
- Disposable Hypodermic Needles
- Disposable Perfusion Sets
- In vitro Diagnostic Devices for HIV, HBsAg and HCV
- Cardiac Stents
- Drug Eluting Stents
- Catheters
- Intra Ocular Lenses
- I.V. Cannulae
- Bone Cements
- Heart Valves
- Scalp Vein
- Orthopedic Implants
- Internal Prosthetic Replacements
- Ablation Devices
IMPORT & DISTRIBUTION MANAGEMENT
REGULATORY REGISTRATION SERVICES
REGULATORY REGISTRATION SERVICES
Benefits of Indian Authorized Agent:
- Appointing Lumbar Healthtech as your Indian Agent provides clarity, confidence and control over your import, distribution and vigilance activities in India.
- Lumbar Healthtech is a full-service provider of medical device license holder services in India. Contracting with us as your India Agent allows you to:
- Sell directly to multiple regional distributors (avoiding mark-up by a national importer)
- Increase transfer pricing (as distributors are not investing in registration costs)
- Improve leverage in distributor negotiations/responses
- Add or change distributors as required
- Keep intellectual property away from local commercial agents
Lumbar Healthtech will involve taking title of the shipment through customs clearance and managing the following activities:
- Order and payment processing
- Arranging shipping (ex-works typical)
- Customs clearance
- Organizing local delivery to regional distributor’s warehouse
- Optional support services are also available such as long-term storage, break-bulk, labelling, and order fulfilment upon client’s request.
Steps for CDSCO Registration
- Determine Device Classification
- Identify the risk category (A, B, C, or D) of your medical device.
- Appoint an Authorized Indian Representative
- If you are an overseas manufacturer, designate a local authorized representative in India.
- Prepare Required Documentation
- Technical documents, clinical data, quality management system certificates, and other relevant documents.
- Submit Application Online
- Use the CDSCO Sugam portal for electronic submission of your application.
- Pay the Required Fees
- Fees vary depending on the class of the medical device.
- Review and Approval
- CDSCO reviews the application. Further information may be requested.
- Obtain Registration Certificate
- Upon approval, receive your device registration certificate.
CDSCO (Central Drugs Standard Control Organization) is the regulatory authority in India responsible for regulating pharmaceuticals and medical devices. For importing medical devices into India, including Class A devices, the process typically involves the following steps:
1. Classification of Medical Device
Firstly, determine the classification of your medical device according to the Medical Device Rules, 2017. Class A medical devices are those with low risk and are subjected to the least regulatory control.
2. Registration of Manufacturer
If you are the manufacturer of the medical device, you need to register your manufacturing facility with CDSCO. This involves submitting an application with relevant documentation, including Good Manufacturing Practices (GMP) compliance.
3. Appointment of Indian Agent
If you are a foreign manufacturer (not based in India), you are required to appoint an authorized agent in India. This agent will act as your representative for communication with CDSCO.
4. Application for Import License
To import medical devices into India, including Class A devices, you need to apply for an import license from CDSCO. The application should include:
- Details of the medical device (technical specifications, intended use, etc.)
- Importer's license or registration certificate (if applicable)
- Authorization letter from the manufacturer (if applicable)
- Quality management system certificate
- GMP certificate (if applicable)
5. Import License Approval
CDSCO will review your application and, if everything is in order, will issue an import license. This license specifies the conditions under which the medical device can be imported into India.
6. Post-Importation Requirements
Once the medical device is imported, ensure compliance with labeling requirements, post-market surveillance, adverse event reporting, and any other regulatory obligations specified by CDSCO.
Notes:
- Authorized Agent: The authorized agent in India plays a crucial role in liaising with CDSCO on behalf of the foreign manufacturer. They ensure that all regulatory requirements are met.
- Regulatory Compliance: Compliance with Indian regulations, including the Medical Device Rules, is essential throughout the importation process.
- CDSCO Guidance: It is advisable to consult with a regulatory expert or legal advisor familiar with CDSCO regulations to navigate the process smoothly.
Navigating CDSCO regulations can be complex, especially for medical devices, so thorough preparation and adherence to regulatory requirements are crucial for successful importation and registration of Class A medical devices in India.
About us
REGULATORY REGISTRATION SERVICES
About us
Lumbar Healthtech Company which is successfully import the products into India with registration.
As an Indian Authorized Agent, Lumbar Healthtech provides high quality and professional services and develop long term relationship for the Indian market by the regulation of CDSCO for registration of the below product.
- Medical Devices
- Medical Equipments
- In Vitro Diagnostics Kits and etc.
Our mission is to provide a stable, reliable local platform so that our clients can grow their sales in challenging Asian markets.
We are medical devices certification consultants Company based in Chennai and we assist our clients worldwide in obtaining the certifications required on medical devices in India on their variety of products.
Appointing an authorized agent to handle the CDSCO import license process provides several benefits for foreign manufacturers. Here are the key advantages:
Local Expertise: Authorized agents possess in-depth knowledge of the Indian regulatory landscape, ensuring that all submissions and processes comply with local laws and guidelines.
Streamlined Processes: Agents can navigate the complex bureaucracy of the CDSCO more efficiently, reducing the time and effort required to obtain the import license.
Regulatory Liaison: Authorized agents act as the primary point of contact between the foreign manufacturer and the CDSCO, facilitating clear and consistent communication.
Documentation Management: Agents manage the preparation, submission, and follow-up of all necessary documentation, ensuring completeness and accuracy, which is crucial for a smooth approval process.
Local Representation: Having a local representative can be mandatory under Indian regulations, as they can respond to any inquiries or issues that arise promptly and effectively.
Market Insights: Authorized agents often have a good understanding of the local market dynamics, helping manufacturers align their strategies with market needs and regulatory requirements.
Compliance Assurance: Agents help ensure ongoing compliance with all regulatory requirements, including post-approval obligations such as adverse event reporting and product renewals.
Risk Mitigation: By leveraging the expertise and local presence of an authorized agent, manufacturers can better navigate potential regulatory pitfalls and reduce the risk of non-compliance.
Cost Efficiency: While there is a cost associated with hiring an authorized agent, the efficiency and expertise they bring can lead to overall cost savings by avoiding delays, rejections, or regulatory penalties.
Focus on Core Activities: Engaging an authorized agent allows the manufacturer to focus on their core activities, such as product development and marketing, while the agent handles regulatory affairs.
Post-Market Support: Authorized agents often provide ongoing support after the product has been approved, assisting with market surveillance, product recalls, and other regulatory requirements.
Local Network: Agents typically have established relationships with key stakeholders in the regulatory and healthcare sectors, which can facilitate smoother interactions and faster resolutions to issues.
In summary, an authorized agent provides essential support, local expertise, and regulatory know-how, significantly easing the process of obtaining and maintaining a CDSCO import license for foreign manufacturers.