1. MDR 2017 in one minute
- Made under the Drugs and Cosmetics Act, 1940 and in force from 1 January 2018.
- Covers medical devices and in-vitro diagnostics (IVDs) for human use.
- Regulator: CDSCO, led by the Drugs Controller General of India (DCGI), together with State Licensing Authorities.
- Uses a risk-based model similar to the IMDRF/GHTF approach — the higher the risk, the stricter the review.
Why it matters
Since the phase-wise extension of licensing, all notified devices — from gloves to stents — need a licence to be made, imported or sold in India.
2. Risk classes A to D
| Class | Risk | Typical examples | Licensing authority |
|---|---|---|---|
| A | Low | Surgical dressings, examination gloves, alcohol swabs | State (SLA) |
| B | Low–moderate | Hypodermic needles, suction equipment, BP monitors | State (SLA) |
| C | Moderate–high | Ventilators, bone fixation plates, haemodialysis equipment | Central (CLA) |
| D | High | Heart valves, coronary stents, implantable pacemakers, HIV IVD kits | Central (CLA) |
- Classification considers intended use, duration of contact, invasiveness and whether the device is active.
- If a device fits more than one rule, the higher class applies.
- Accessories are classified on their own; IVDs have separate rules.
3. Who grants what: SLA vs CLA
| Topic | State Licensing Authority (SLA) | Central Licensing Authority (CLA / CDSCO) |
|---|---|---|
| Manufacturing — Class A & B | Yes | — |
| Manufacturing — Class C & D | — | Yes |
| Import — all classes | — | Yes |
| Clinical investigations | — | Yes |
| Pre-licence audit | Notified Body audit (Class B) | CDSCO inspection with state officers |
Easy rule to remember
State = low-risk Indian manufacturing. Centre = high-risk manufacturing plus every import.
4. Manufacturing licence forms
| Licence | Device class | Apply on | Licence granted on |
|---|---|---|---|
| Manufacturing | A & B | MD-3 | MD-5 |
| Loan licence | A & B | MD-4 | MD-6 |
| Manufacturing | C & D | MD-7 | MD-9 |
| Loan licence | C & D | MD-8 | MD-10 |
- Class A: document review; the site may be audited after the licence is granted.
- Class B: a registered Notified Body audits the site before the licence.
- Class C & D: CDSCO inspects the site before the licence.
- Licences stay valid as long as the retention fee is paid on time.
5. Importing devices into India
- 1The overseas manufacturer appoints an Authorised Indian Agent holding a wholesale licence (MD-42).
- 2The agent applies to CDSCO on Form MD-14.
- 3CDSCO reviews the dossier and grants the import licence on Form MD-15.
Typical import dossier
- Power of attorney from the manufacturer (legalised as required)
- Free sale certificate from the country of origin
- ISO 13485 certificate and Plant Master File
- Device Master File with labels and IFU
- Risk management summary (ISO 14971)
6. QMS: the Fifth Schedule
- The Fifth Schedule sets the quality system requirements for manufacturers.
- Its structure closely follows ISO 13485:2016, so an ISO 13485 QMS covers most of it.
- Inspectors often look at: cleanroom and environment control, calibration, process validation, batch records, complaint handling and CAPA.
| Area | What inspectors usually ask for |
|---|---|
| Documents | Approved SOPs, device master record, change control |
| Production | Validated processes (IQ/OQ/PQ), batch manufacturing records |
| Environment | Cleanroom classification, monitoring records |
| Suppliers | Approved supplier list and evaluations |
| Feedback | Complaints, CAPA and recall procedure |
7. Labelling basics (Rule 44)
Check every label for
- Device name and, where relevant, brand name
- Manufacturer name and site address
- Importer name, address and import licence number (for imports)
- Manufacturing licence number (for Indian products)
- Batch/lot or serial number, manufacturing and expiry date
- Sterile status and method, single-use warning where applicable
- Storage conditions and net contents
8. After the licence: vigilance
- Report adverse events and field safety actions to CDSCO.
- The Materiovigilance Programme of India (MvPI) is run by the Indian Pharmacopoeia Commission, Ghaziabad.
- Keep complaint trends, recalls and CAPA records ready for inspection.
- Notify CDSCO of major changes to the device, site or labels before making them.
9. Filing checklist on the CDSCO online portal
- 1Register the company and authorised signatory on the CDSCO medical device portal.
- 2Confirm the device class from the CDSCO classification list.
- 3Prepare the Device Master File and Plant Master File.
- 4Pay the government fee online.
- 5Submit the application and answer queries quickly.
- 6Complete the audit or inspection and download the licence.
Always check the latest notices
CDSCO issues frequent notices and amendments. Confirm current forms, fees and timelines on the official CDSCO website before you file.
10. Quick summary
| Question | Short answer |
|---|---|
| Who regulates? | CDSCO with State Licensing Authorities |
| How many classes? | Four: A, B, C, D |
| Class A/B licence? | MD-3 → MD-5 from the State |
| Class C/D licence? | MD-7 → MD-9 from CDSCO |
| Import licence? | MD-14 → MD-15 through an Indian agent |
| QMS standard? | Fifth Schedule, aligned with ISO 13485 |
Want to test yourself? Take the free SkillMed Indian MDR course for a verifiable certificate, or try the 15-question QMS Master Challenge at skillmed.in/qms-challenge.
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