License for manufacturing of Medical Devices including in-vitro
diagnostic devices are issued online at the CDSCO portal
as per the provisions of Drugs & Cosmetics Act and
Medical Device Rules 2017. The Licensing Authority for such licenses for Class A
and B products is the Drugs Controller of the state.
Stage 1
Application for grant of Manufacturing Licence
The applicant has to make application online at the CDSCO portal in requisite form such as MD-3, MD-7 (or MD-4, MD-8 for loan license) for license to be issued on form MD-5, MD-9 (or MD-6, MD-10 for Loan Lic).
Fee can be paid through Government Treasury challan, under Head of Account 0210- XX-XXX-XX-XX Other receipts
Documents to be uploaded along with the application form:
- Covering Letter
- Application Form.
- Receipt of fees challan
- Constitution of firm including
a. Partnership deed / Memorandum & Article of Association
b. Declaration of Proprietor/ Partners/ Director(s)/ Managing Director
c. List of all the Partners/ Directors with age & complete postal & residential
address. - Documents of Site ownership / Tenancy agreement
- Plant Master File (as per appendix I of Part III of fourth schedule)
Apart from the mandatory information as per appendix I of Part III of fourth schedule,
following documents should also be submitted:
a. Declaration of Manufacturing Chemist.
b. Declaration of Analytical Chemist.
c. Documents of educational qualification, experience and approval certificates of
proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters; Id
proof.
d. Registration from District Industries Centre.
e. Consent from Pollution Control Board. - Device Master File for each product (as per appendix II / appendix III of fourth schedule)
- Performance Evaluation Report (if applicable)
- Copy of Test License (if applicable).
- Undertaking that the manufacturing site is in compliance with the provisions of Fifth Schedule.
Following additional documents are required if applied for loan license on Form MD-4, MD-8: - Consent letter from principal manufacturing unit in case of loan license.
- Wholesale licenses of the applicant loan licensee.
- Valid manufacturing licenses and copies of product permission of the product in question
of the principal manufacturer.
Stage 2
Scrutiny of application. In case any shortcoming / discrepancy is noted, query shall be raised.
Further action shall be taken upon receipt of reply of query from the applicant. In case the
application is found in order, it will be processed for audit of factory premises by a notified body
as per Medical Device Rules.
Stage 3
Audit of applicant premises by notified body in case of Class A & B Medical devices and by CDSCO Zonal Team in case of Class C & D Medical Devices. The non-compliances, if any, shall be rectified by
the applicant. The audit report and the NC closure will be uploaded by the notified body.
Stage 4
Upon receipt of the audit report, it will be examined and if found satisfactory, it will be
forwarded for the next step.
Stage 5
Products Scrutiny. The details of the products applied for shall be scrutinized and if they are
found to comply with the norms, the application will be considered for grant of license.
Stage 6
Grant of Licence
If all the prescribed conditions are complied with, licence is granted