Under G.S.R. 78(E) – Medical
Devices Rules, 2017, any manufacturer intending to manufacture a new In
Vitro Diagnostic (IVD) medical device in India must obtain prior permission
from the Central Drugs Standard Control Organization (CDSCO).
Who
Needs Approval?
Any Indian manufacturer who plans
to:
- Manufacture a new IVD medical device, and
- Sell or distribute it in the Indian market
must apply to CDSCO before starting
production or marketing.
Application
for Grant of Permission
The application is submitted through
the CDSCO online portal (SUGAM) in the prescribed format.
Key
Details Required in the Application
1.
Applicant Information
- Name of the applicant
- Nature of the organization
(Proprietorship / Partnership / LLP / Company / Trust / Society)
2.
Address Details
- Corporate / Registered Office Address
- Manufacturing Site Address
- Authorized Agent Address (if applicable)
- Contact details including phone number and email ID
3.
Manufacturer & Manufacturing Site Details
- Name and full address of the manufacturer
- Name and full address of each manufacturing site
- Contact details of all locations
Details
of the New IVD Medical Device
The applicant must provide complete
details of the new IVD device, including:
- Generic name
- Model number
- Intended use
- Risk classification (Class A, B, C, or D)
- Materials of construction
- Dimensions (if applicable)
These details are usually submitted
in an Annexure format.
Documents to be Submitted
As per Part IV of the Fourth
Schedule of MDR, 2017, the following documents are required:
- Device Master File (DMF)
- Plant Master File (PMF)
- Free Sale Certificate (if applicable)
- Risk analysis report
- Clinical performance evaluation data (for IVDs)
- Quality Management System (ISO 13485)
- Labels, IFU, and package inserts
- Any additional documents as specified by CDSCO
Fee Payment
- The prescribed government fee must be paid online
- Fee details such as date, amount, and transaction ID
must be mentioned in the application
Declaration by the Applicant
The applicant must declare that:
- All submitted information is true and correct
- All documents required under MDR 2017 have been
enclosed
The application must be digitally
signed by an authorized signatory.
Approval by CDSCO
Once submitted:
- CDSCO reviews the application and documents
- Queries (if any) must be addressed by the applicant
- Upon satisfaction, CDSCO grants permission to
manufacture the new IVD medical device in India
Conclusion
Manufacturing a new IVD medical
device in India requires strict compliance with G.S.R. 78(E) under the
Medical Devices Rules, 2017. Proper documentation, accurate device information,
and regulatory compliance are essential for obtaining CDSCO approval smoothly.
