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Procedure To Obtain Manufacturing License For Medical Devices

The document outlines the 6 step process for obtaining a manufacturing license for medical devices in India. Applicants must apply online, paying fees as required. Required documents include details of the company/organization, site ownership documents, plant and device master files, and qualifications of manufacturing and analytical chemists. The application then goes through scrutiny, an audit of the manufacturing site, product scrutiny, and if all is found to comply with regulations, a license will be granted.

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Sachin Pisal
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237 views2 pages

Procedure To Obtain Manufacturing License For Medical Devices

The document outlines the 6 step process for obtaining a manufacturing license for medical devices in India. Applicants must apply online, paying fees as required. Required documents include details of the company/organization, site ownership documents, plant and device master files, and qualifications of manufacturing and analytical chemists. The application then goes through scrutiny, an audit of the manufacturing site, product scrutiny, and if all is found to comply with regulations, a license will be granted.

Uploaded by

Sachin Pisal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Procedure to obtain Manufacturing License for Medical Devices

License for manufacturing of Medical Devices including in-vitro


diagnostic devices are issued online at the CDSCO portal
cdscomdonline.gov.in 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 Controllerof the state.
[License for Class C and D products is granted by the Central Licensing Authority,
New Delhi]

Step 1

Application for grant of Manufacturing Licence


The applicant has to make application online at the CDSCO portal cdscomdonline.gov.in
inrequisite form such as MD-3 (or MD-4 for loan license) for license to be issued on form MD-5,
or as applicable as per the Medical Device Rules, along with necessary fees challanas given in
fee chart under ‘Forms & Fees’.
Fee can be paid through Government Treasurychallan, under Head of Account-
0210- 04-800-02-00 Other receipts
Department Name: Drugs Controller, Rajasthan, Jaipur
Office Name: Asstt. Drugs Controller, NDNP, Jaipur, Rajasthan

Documents to be uploaded along with the application form:

1. Covering Letter
2. Application Form.
3. Receipt of fees challan
4. 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.

5. Documents of Site ownership / Tenancy agreement


6. 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 to establish & consent to operate from Rajasthan State Pollution Control
Board.

7. Device Master File for each product (as per appendix II / appendix III of fourth schedule)
8. Performance Evaluation Report (if applicable)
9. Copy of Test License (if applicable).
10. 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:
1. Consent letter from principal manufacturing unit in case of loan license.
2. Wholesale licenses of the applicant loan licensee.
3. Valid manufacturing licenses and copies of product permission of the product in question
of the principal manufacturer.

Step 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.

Step 3
Audit of applicant premises by notified body. 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.

Step 4

Upon receipt of the audit report, it will be examined and if found satisfactory, it will be
forwarded for the next step.

Step 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.

Step 6
Grant of Licence
If all the prescribed conditions are complied with, licence is granted.

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