Requirements for Grant of Licence in Form-28 for Manufacture of Medical Devices in India
Application for the grant of licence for manufacture of Medical Devices in India shall be made in Form 27 to:-
- The concerned State Drugs Licensing Authority, Address of all SLA are placed at Annexure-I.
- The concerned CDSCO Zonal/Sub-Zonal Office. Address of CDSCO offices are placed at Annexure-II and
- The Drugs Controller General of India CDSCO (HQ), FDA Bhawan, Near Bal Bhawan, ITO, Kotla Road, New Delhi-110002.
accompanied by the requisite fee in the form and manner as prescribed in the Drugs & Cosmetics Rules.
The following documents are required to be submitted in the following manner and order for grant of licence in Form-28 for Manufacture of Medical Devices in India: –
1. Covering Letter – The covering letter is an important part of the application and should clearly specify the intent of the application. The list of documents that are being submitted (Index with page number) as well as any other important and relevant information may be provided in the covering letter. The covering letter should be duly signed and stamped by the authorized signatory, indicating the name & designation of the authorized signatory.
2. An Authorization letter in original issued by the Director/Company Secretary/Partner of the Indian Agent firm revealing the name & designation of the person authorized to sign legal documents such as Form-27 on behalf of the firm should be submitted at the time of submission of the application for grant/Renewal of licence. It should have validity period as per company’s policies. Duly attested photocopies of the Authorization letter may be submitted at the time of submission of subsequent applications.
3. A duly filled Form 27 as per the Performa prescribed in the Drugs & Cosmetics Rules, signed & stamped by the Indian Agent along with name & designation.
The requisite fee as prescribed in the Drugs & Cosmetics Act & Rules viz. Licence fees of Rs.6000/- and an
4. Inspection fees of Rs. 1500/- (Total Rs. 7500/- for 10 items for each category of Device) and additional fees at the rate of Rs.300/- for a each additional item of Device.
5. Constitution Details Documents relating to constitution of firm viz. partnership-deed, memorandum and article of association etc.
6. Approved Manufacturing Premises Plan/Layout. A copy of Plan/layout approved by the Drugs Licensing Authority should be submitted as stated in Site Master File at C-I
7. Full particulars of competent and regular technical staff for manufacturing and testing of Medical Devices along with the copies of Educational Qualification, Experience Certificate, Appointment Letter, Acceptance Letter, Joining letter etc.
8. Site Master File
9. Specific Environmental Requirements
10. Device Master File for each category of device.
11. List of Medical Devices along with undertaking
12. Details of Standards followed by the company for product evaluation
13. Promotional literature, package insert, device labels etc
14.ISO 13485:2003 Certificate (if any)
15. Full Quality Assurance Certificate (if any)
16. CE Design Certificate (if any)
17. Declaration of Conformity (if any)
18. Any other approvals (e.g. US FDA)
- All certificates submitted should be within the validity period.
- In case of New Devices/not yet approved in India, the applicant has to submit a copy of necessary permission/NOC from the Drugs Controller General (I) along with the application.
- In case the applicant intends to manufacture both SLA(Syringes, needles and perfusion sets) and CLAA (remaining devices) devices, separate applications should be made and separate licenses should be obtained from the concerned licensing authorities.
Web Link for Download:
Guidance document on common submission format for Manufacture of Medical Devices (Form-28) Under CLAA Scheme
Feel free to contact us for any query or clarification
Dr. Manoj Karwa
Head- Clinical Operations
Auriga Research Ltd
Disclaimer: Auriga Research Ltd has tried to arrange content in a simplified manner and accepts no liability for the content. For more updated information, Please visit CDSCO website or link provided above.