In India, approved medical devices are regulated like pharmaceuticals under the 1940 Drugs and Cosmetics Act and its 1945 Rules. For approved medical devices in India, the Central Drugs Standards Control Organization (CDSCO) sped up the application procedure for awarding market standing certifications and non-conviction certificates.
This action is being done to help importers or makers of medical devices in India file their requests for Non-Conviction Certificates of Notified Medical Devices. This applies to Indian makers and importers of medical devices who have an active license for manufacturing or importing and who want to get a Non-Conviction Certificate of Notified Medical Devices.
The non conviction certificate mainly certifies that a firm or a manufacturer who is holding the valid drug manufacturing license for a certain period has not been convicted under Drug & Cosmetic Act, 1940.
Depending on when the license expires, the Market Standing Certificate will be valid for one year from the date of issuance.
It is certified that M/s ———————————- situated at —————————— ————— are holding valid drug manufacturing license No.——————- valid till _______________ The firm has not been convicted under Drug & Cosmetic Act, 1940 and rules there under in _______ State.
State Drug Controller,
Certifying & Licensing Authority
Directorate General Health Services
The State Drug Controller of the Central Licensing Authority of the Directorate General of Health Services must receive an application from manufacturers who have active licences to make medical devices for sale or distribution.
The purpose of the application should be made crystal clear in the covering letter. Any other significant or pertinent information, including the list of papers being presented (indexed with page numbers), may be included in the covering letter. The authorized signatory must properly sign and stamp the covering letter, confirming their name and title as well as the name and address of the company.
The manufacturer or importer must sign a legal declaration on a 100 Rupee registered, notarized stamp stating that no legal action has been taken against them or that they have not been found guilty as a result of unfavorable events, market complaints, or Not of Standard Quality (NSQ) reports of any products in India.
The state drug controller of the certifying & Licensing Authority of the directorate general health services who has issued the license shall issue the non conviction certificate.
