The highest Indian regulatory body supervising the manufacturing of notified medical devices is the Central Drugs Standard Control Organisation (CDCSO). In India, the regulatory authority is responsible for giving license and approval for the manufacturing of medical devices. This regulatory authority provides the manufacturing licenses in Form MD-9 which is required as per the provision of Medical Device Rules, 2017.
An application needs to be submitted to the Central Licensing Authority for a manufacturer license. This can be applied through the online portal of the Central Government. A manufacturer license allows the sale or distribution of Class C and Class D medical devices in Form MD-9 which is obtained by applying via Form MD-7.
The application for permission to manufacture Class C & D Medical Devices can be submitted by any person who wishes to manufacture these devices through Form MD-7.
A manufacture must apply for a Grant of License to manufacture for Sale and distribution Class C or Class D medical devices
|Application can be made to the Central Licensing Authority in Form MD-7|
The application requires the following documents:
A valid Form MD-9 license does not have fixed expiry date; it lasts forever subject to the timely payment of license retention fee within 5 years of the issue date as per the Second Schedule, unless it is suspended/ cancelled by the Central Licensing Authority . Upon failure of payment on time, the license stands suspended/cancelled.
The necessary documents required for the application with Form MD-7 are –
For Class C and D devices, the manufacturing site of the applicant must be according to the requirements of the Quality Management System that are mentioned under the Fifth Schedule. The device master files and site master files are essential and need to be prepared as per the format given in MDR 2017 at the time of application.
During the submission process, manufacturers can experience problems if the technical documents of the products are not filed according to MDR 2017. To avoid undue delay, these documents must be completely prepared as per the latest MDR guidelines.
The quality control data is generated based on a valid Test License must be submitted during the application process for quick approval.
After the submission of the application, within sixty days CDSCO inspects the manufacturing site of the Class C& D Medical devices.
A team comprising of minimum two medical device officers, one could be any officer senior to the medical device officer, with or without an expert, or a Notified Body.
The Central Licensing Authority conducts the inspection for class C and class D within a period of 60 days from the date of application. After complete satisfaction, Central Licensing Authority may grant a license within a period of forty-five days from the date the inspection report is received.
Yes. The undertaking signed stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule of MDR 2017 needs to be submitted in case of manufacture of Class C and D medical devices.
Yes. The medical device must obey the standards laid down by the BIS established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time. If no relevant standard of any medical device has been laid down under sub-rule 1, such device shall follow the standard laid down by the International Organization for Standardization (ISO) or the International Electro-Technical Commission (IEC), or by any other pharmacopoeia standards. In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall follow the validated manufacturer’s standard.
If the device has already been marketed and the Government of India notifies the same under 3(b)(iv) of the Drugs and Cosmetics Act, 1940 (23 of 1940), then the device will be regulated under the Medical Device Rules 2017.
Each medical device will be deliberated on a case-to-case basis, on the basis of their intended use, and with data available, to substantiate their safety and effectiveness. The matter may also be placed before Subject Experts Committee (SEC).