In India import, manufacture, sale and distribution of Medical devices is regulated under Drugs and Cosmetics Act, 1940; and Rules, 1945.
- Cardiac Stents
- Drug Eluting Stents
- Intra Ocular Lenses
- I.V. Cannulae
- Bone Cements
- Heart Valves
- Scalp Vein Set
- Orthopedic Implants
- Internal Prosthetic Replacements
Documents required for applying for Manufacturing License of Medical Devices:
Manufacture of notified medical devices (Under CLAA Scheme) for sale in India, License in Form-28 is required under Drugs and Cosmetics Rules. The Rule 76 of Drugs and Cosmetics Rules describe the information/data required for grant of manufacturing license. Application is to be submitted to Licensing Authority appointed by the State Government or Center Government.
Below we are listing detail of documents that will be required for applying for grant of licence in form-28 for Manufacture of Medical Devices in India:
- 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 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.
- 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.
- 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 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.
- Constitution Details Documents relating to constitution of firm viz. partnership-deed, memorandum and article of association etc.
- 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
- 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.
- Site Master File as per Annexure-IV
- Specific Environmental Requirements as per Annexure-V
- Device Master File as per Annexure-VI for each category of device.
- List of Medical Devices along with undertaking in prescribed pro-forma as per Annexure VII.
- Details of Standards followed by the company for product evaluation
- Promotional literature, package insert, device labels etc
- ISO 13485:2003 Certificate (if any)
- Full Quality Assurance Certificate (if any)
- CE Design Certificate (if any)
- Declaration of Conformity (if any)
- Any other approvals (e.g. US FDA)
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.
All certificates submitted should be within the validity period.