As per G.S.R. 78(E) under the
Medical Devices Rules, 2017, any company intending to import a new In
Vitro Diagnostic (IVD) medical device into India must obtain prior
permission from CDSCO before import, sale, or distribution.
Who Requires Import Permission?
An Indian authorized agent or
importer must apply to CDSCO if:
- The IVD device is new (not previously approved
in India), and
- The device is intended to be imported for sale or
distribution in India
Application for Grant of Import Permission
The application must be submitted
online through the CDSCO SUGAM portal in the prescribed format.
Information Required in the Application
1.
Applicant Details
- Name of the applicant / Authorized Indian Agent
- Nature and constitution of the applicant
(Proprietorship / Partnership / LLP / Company / Trust)
2.
Address Details
- Corporate / Registered Office Address
- Authorized Agent Address in India
- Overseas Manufacturer Address
- Contact details including phone number and email ID
3.
Manufacturer & Manufacturing Site Details
The applicant must provide:
- Name and address of the foreign manufacturer
- Name and address of all manufacturing sites
- Contact details of each site
Details of the New IVD Medical Device
Complete device information must be
provided in an Annexure, including:
- Generic name of the IVD device
- Model number
- Intended use
- Risk classification (Class A, B, C, or D)
- Materials of construction
- Dimensions (if applicable)
Documents Required for Import Permission
As per Part IV of the Fourth
Schedule of MDR, 2017, the following documents are required:
- Authorization letter from the foreign manufacturer
- Device Master File (DMF)
- Plant Master File (PMF)
- Free Sale Certificate from the country of origin
- Quality Management System certificate (ISO 13485)
- Risk analysis report
- Clinical performance evaluation data (IVD-specific)
- Labeling, Instructions for Use (IFU), and package
inserts
- Undertaking and declaration by the authorized agent
Fee Payment
- Government fees must be paid online through the CDSCO
portal
- Details such as fee amount, date of payment, and
transaction ID must be mentioned in the application
Declaration by the Applicant
The authorized agent/importer must
declare that:
- All information submitted is true and accurate
- All documents specified under MDR 2017 have been
enclosed
The application must be digitally
signed by the authorized signatory.
CDSCO Review & Approval
- CDSCO reviews the application and supporting documents
- Any queries raised must be responded to within the
stipulated time
- Upon satisfactory review, CDSCO grants permission to
import the new IVD medical device
Conclusion
Import of a new IVD medical device
into India requires strict compliance with G.S.R. 78(E). Timely
submission of accurate documentation, proper authorization, and regulatory
alignment with CDSCO ensure a smooth approval process.
