Medical Device Registration in India

Short answer. In India you don't "register" most medical devices. You need a licence under the Medical Devices Rules, 2017 (MDR-2017), administered by CDSCO. CDSCO's 2024 FAQ says that, since G.S.R. 102(E) of 11.02.2020, all devices need an import or manufacturing licence. The one exception is Class A non-sterile, non-measuring devices: these are exempt from licensing but must be registered on the Medical Devices Online portal, for no fee, in return for a system-generated number. Which form you file, and with which authority, depends on two things: whether you import or manufacture in India, and the device's risk class (A to D).

Approach: The Indian datasets (MDR-2017 text, CDSCO FAQs and circulars) didn't respond this time. Everything below comes from the official CDSCO site: the 2024 MDR FAQ (CDSCO/FAQ/MD/01/2024) and the MDR-2017 text published by CDSCO.

1. Confirm the device and its risk class

• All medical devices fall under MDR-2017 under notification S.O. 648(E) of 11.02.2020. That includes animal-use devices and standalone software, and covers software for fitness or wellness if it meets the device definition (FAQ Q1, Q4, Q67-68).
• The classes are A (low risk), B (low-moderate), C (moderate-high) and D (high). The criteria are in Part I of the First Schedule; IVDs are covered in Part II.
• Only the Central Licensing Authority (the DCG(I)) classifies devices, using the risk-classification list on the CDSCO website. If your device isn't on the list, you send CDSCO a classification request with the label, the IFU and the device's regulatory status in other countries (FAQ Q74-78).
• If an import is classed differently in IMDRF/GHTF countries, the licensing authority may apply the higher class (FAQ Q93).

2. Choose the pathway

Applications go online through cdscomdonline.gov.in or nsws.gov.in (FAQ Q8).

Scenario	Authority	Application → licence	Statutory timeline
Class A, non-sterile and non-measuring (import or manufacture)	Registration on the online portal	System-generated number, no fee	n/a (FAQ Q69-71)
Manufacture, Class A (other than above)	State Licensing Authority	MD-3 (loan licence: MD-4) → MD-5 / MD-6	Grant or rejection within 45 days. No pre-licence audit. A Notified Body audit must follow within 120 days of grant (Rule 20(4))
Manufacture, Class B	State Licensing Authority	MD-3 / MD-4 → MD-5 / MD-6	Notified Body audit within 90 days of application, report within 30 days of the audit, decision within 20 days of the report (Rule 20(5)-(6))
Manufacture, Class C or D	Central Licensing Authority (CDSCO)	MD-7 / MD-8 → MD-9 / MD-10	Document scrutiny in 45 days (Rule 21). Site inspection within 60 days of application (Rule 23). Decision within 45 days of the inspection report (Rule 25)
Import, any class	Central Licensing Authority	MD-14 → MD-15	Within 9 months of application (Rule 36(1))

Key points for each route:

• Notified Body (Classes A and B): you can't choose your Notified Body. The State Licensing Authority assigns a CDSCO-registered one (FAQ Q83).
• Importers: the applicant must be an authorised agent appointed by the overseas manufacturer through a power of attorney. The agent must also hold a manufacturing licence, a wholesale licence or an MD-42 registration (Rule 3(f), Rule 34(1), FAQ Q90).
  • The power of attorney must be authenticated by a First Class Magistrate, the Indian Embassy, or by apostille (Fourth Schedule, Part I).
  • CDSCO "may" inspect the overseas site, at a fee of $6,000 (Rule 35; Second Schedule item 30).
• Free sale certificate from a reference market: if the device already has one from Australia, Canada, Japan, the EU or the USA, the import licence "shall be granted… without carrying out clinical investigation" (Rule 36(3)).
• Devices from other countries:
  • Class C and D: may need clinical investigation in India (Rule 36(4)).
  • Class A and B: need published safety and performance data, or clinical investigation in the country of origin, plus that country's free sale certificate (Rule 36(5)).

3. Dossier (Fourth Schedule)

• Class A: device description and intended use, materials, working principle, labels and IFU, summary of serious adverse events, plant master file, constitution of the firm, essential principles checklist, and an undertaking of compliance with the Fifth Schedule QMS.
• Classes B, C and D: everything above plus a full Device Master File (Appendix II, or Appendix III for IVDs), any test licence, and, for IVDs, a performance evaluation report from a CDSCO-registered lab.
• Import applications, any class, also need notarised copies of:
  • the site registration in the country of origin and the free sale certificate;
  • the QMS certificate;
  • the latest audit report from the last 3 years, if one exists.
• Free sale certificate details: it must name both the legal and the actual manufacturer. A certificate of exportability is not accepted (FAQ Q108, Q111).

4. Novel devices, IVDs and testing

• Device with no predicate (investigational device): you need prior permission in MD-27 (via an MD-26 application). For a new IVD it is MD-29. No licence of any class is granted without that permission (Rules 25(4), 36(6)).
• Clinical investigation: needs permission in MD-23.
• Waiver for no-predicate imports: CDSCO may waive the clinical investigation case by case, with its Subject Expert Committee, if the device has been approved and marketed for at least 2 years in the UK, USA, Australia, Canada or Japan (FAQ Q113, Q117-118).
• Test licences: for test, evaluation, demonstration or training batches. Manufacture: MD-12 → MD-13. Import: MD-16 → MD-17. Each is granted within 30 days and is valid for 3 years (Rules 31, 40-41).

5. Government fees (Second Schedule)

Fees are charged per brand; there is no refund (FAQ Q14-15).

Licence	Per site	Per distinct device
Manufacture, Class A/B	INR 5,000	INR 500
Manufacture, Class C/D	INR 50,000	INR 1,000
Import, Class A (non-IVD)	$1,000	$50
Import, Class B (non-IVD)	$2,000	$1,000
Import, Class C/D (non-IVD)	$3,000	$1,500
Import, Class A/B IVD	$1,000	$10
Import, Class C/D IVD	$3,000	$500

Other fees:

• Pilot or pivotal clinical investigation: INR 100,000 each.
• No-predicate device permission: INR 50,000.
• New IVD permission: INR 25,000.

6. After you have the licence

• Validity: licences are valid in perpetuity, provided the retention fee is paid every 5 years. Late payment carries a surcharge of 2% per month:
  • Manufacturers: within 180 days, or the licence is deemed cancelled (Rule 29).
  • Importers: within 90 days (Rule 37).
• Changes (Sixth Schedule):
  • Major changes need prior approval. CDSCO has 45 days for manufacturers and 60 days for importers; if it doesn't reply in time, the change is deemed approved (Rules 26(iii), 38(1)(v)-(vi)).
  • Minor changes must be notified within 30 days.
  • A change of authorised agent, of the overseas manufacturer's constitution, or of the manufacturing site location requires a fresh import licence (FAQ Q92, Q104).
• Vigilance:
  • Manufacturers must report suspected unexpected serious adverse events, and recalls, within 15 days (Rule 26(ii)).
  • Importers must report regulatory action taken abroad within 15 days (Rule 38(1)(ii)).
• Notifying a change in constitution (importers): the published sources disagree. Rule 38(1)(viii) in the CDSCO-hosted text says the agent must inform CDSCO within 30 days; FAQ Q109 says 45 days.
• Labelling and import logistics:
  • Labels must meet Chapter VI. India-specific details, such as the import licence number, may be added by sticker (FAQ Q31, Q99).
  • Imports may come in only through ports notified under the Drugs Rules, 1945 (FAQ Q106).
• Distribution: a trader who handles only devices needs an MD-42 registration from the State Licensing Authority (application in MD-41). It should be issued within 10 days (FAQ Q144-147).

If you tell me the device and whether you're importing or manufacturing, I can look up its class in CDSCO's risk-classification lists and list the exact forms, documents and fees.