Key regulatory framework
Overview of the licence/registration process under the Central Drugs Standard Control Organisation (CDSCO) / Medical Devices Rules, 2017 (MDR-2017) in India
- Import licence for medical devices: Application in Form MD-14 (to import) → Licence in Form MD-15.
- Manufacturing licence for “manufacture for sale or distribution” of medical devices: For Class C & D, apply via Form MD-7/MD-8 (for sale/distribution) → licence forms MD-9/MD-10.
- Test licence (for manufacture or import for test, evaluation, clinical investigation, demonstration, training) – Forms MD-12/MD-13 (manufacture), MD-16/MD-17 (import) respectively.
- Registration certificate (especially for low-risk devices) – earlier there was a “registration” (rather than full licence) regime for some devices. For example, Class A (non-sterile & non-measuring) devices had to register instead of full licence.
Key steps you (as manufacturer/importer) need to follow
Overview of the licence/registration process under the Central Drugs Standard Control Organisation (CDSCO) / Medical Devices Rules, 2017 (MDR-2017) in India
Here is a rough step-by-step, especially useful given your interest (medical device manufacturing/importing, e.g., spine products, etc.):
Device classification: Determine whether your device is Class A/B/C/D under the schedule of MDR-2017.
Appoint Indian Authorised Agent (if you are foreign manufacturer and planning to import): The importer or Indian agent must have appropriate licence/registration.
Prepare documentation: Among other things, you’ll need: Device Master File (DMF), Plant Master File (PMF), quality management system certificate (eg. ISO 13485), labelling/IFU, manufacturing/sterilisation details, free sale certificate from country of origin (if applicable) especially for import.
Submission of application online via SUGAM portal (CDSCO’s online portal) with required form, documents and fees.
Inspection / audit of manufacturing site (depending on class of device). For example:
Class B, C, D devices: inspection of manufacturing site prior to licence grant.
Class A (other than non-sterile & non-measuring) may also require audit.
Grant of licence / registration certificate. For import/manufacture etc.
Post-grant obligations: Retention/renewal fee (often every 5 years), post-market surveillance, change notifications (endorsements) for model changes, accessories etc.
CDSCO Manufacturing License — Complete Support for Medical Device Manufacturers
Setting up a medical device manufacturing facility in India requires strict compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations.
We assist companies in obtaining CDSCO Manufacturing Licenses under the Medical Device Rules (MDR), ensuring seamless approval and timely market entry.
🔹 What Is a CDSCO Manufacturing License?
A CDSCO Manufacturing License authorizes companies to manufacture Class A, B, C or D medical devices in India.
The license ensures that the manufacturing unit complies with Quality Management System (QMS) requirements and Good Manufacturing Practices (GMP) as per MDR 2017.
🔹 Who Needs This License?
Any entity manufacturing the following requires a CDSCO Manufacturing License:
- Medical devices (Class A to D)
- IVD devices
- Surgical instruments
- Implants & orthopedic devices
- Healthcare equipment
- Diagnostic and therapeutic devices
🔹 Categories of Manufacturing Licenses
- Form MD-5 → Manufacturing License for Class A & B Devices
- Form MD-9 → Manufacturing License for Class C & D Devices
- Form MD-10 → Loan License for Class A & B
- Form MD-12 → Loan License for Class C & D
🔹 Requirements for Obtaining the License
We support the end-to-end documentation including:
- Site Master File
- Device Master File
- QMS compliance (ISO 13485)
- Plant layout & equipment details
- Testing facility details
- Competent Technical Staff (CTS) documents
- Undertakings & statutory declarations
- Application via CDSCO SUGAM/NSWS portal
🔹 Our Services
We provide comprehensive assistance:
✔ Facility audit & readiness assessment
✔ Documentation drafting (DMF/SMF)
✔ Portal application submission
✔ Coordination with CDSCO officers
✔ Support till license approval
🔹 Why Choose Us?
- Experienced team in India & international regulatory approvals
- Fast and error-free documentation
- Affordable pricing with transparent process
- Approved projects across multiple medical device categories
About LUMBAR HEALTHTECH
Our Mission
At LUMBAR HEALTHTECH, our mission is to ensure the safe and effective use of medical devices. We strive to provide comprehensive regulatory solutions that empower manufacturers and importers to meet compliance standards set by the CDSCO.