By notification in the official gazette with the Board’s consultation, the Central Government of India, specify the list of medical devices from time to time. Medical devices are meant for internal or external use in the diagnosis, prevention, treatment and mitigation of diseases in human beings or animals. Medical devices are regulated by Drugs & Cosmetic Act 1940 & Rules 1945. Application for registration is submitted to the Drugs Controller General of India.
Necessary documents mandatory to acquire license permit:
Granting license for manufacturing of medical devices requires filling Form-28 along with prescribed government fees in the form and manner as prescribed by the Act.
This application shall be submitted to the:
- Concerned State Drugs Licensing Authority,
- Concerned CDSCO zonal/sub-zonal office,
- The Drugs Controller General of India
Covering Letter- it speaks about the intent of the application. All the relevant information regarding documents is to be specified. A list should be prepared to specify page numbers and it shall be duly signed and stamped by authorized signatory making the application.
Authorization Letter- 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 license. It shall be issued by the Director/Company Secretary/Partner of the Indian Agent firm in the original. Photocopies of the authorization letter may be submitted but must be duly attested.
Form 27- a duly filled Form 27 in the manner prescribed in the Drugs & Cosmetics Rules, signed & stamped by the Indian Agent along with name & designation.
Fee- as prescribed in the Drugs & Cosmetics Act & Rules viz. License fees of Rs.6000/- and 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 an each additional item of Device.
Constitution details of the firm- documents like partnership deed, memorandum of association shall be submitted.
Details of technical staff- educational qualifications, experience certificate, joining letter and other details relating to the staff members who are responsible for the handling of medical devices is to be submitted.
Manufacturing premises layout- a copy of layout/plan approved by Drugs Licensing Authority shall be submitted.
Specific environmental requirements
- List of medical devices
- Detail of standards to be followed for production purposes.
- Full quality assurance certificate
- CE design Certificate
- Any other approvals.
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