In India, the Drugs and Cosmetics Act of 1940 and its Rules from 1945 govern recognised medical devices as drugs. The Central Drugs Standards Control Organization (CDSCO) expedited the application process for issuing market standing certificates and non-conviction certificates for notified medical devices in India.This action is being taken to assist Indian medical device importers or manufacturers in submitting their applications for Market Standing Certificates of Notified Medical Devices.This applies to Indian importers and manufacturers of medical devices who wish to get a Market Standing Certificate of Notified Medical Devices and who hold a current manufacturing or import license.
The market standing certificate basically certifies that a particular manufacturer who has a valid license is allowed to manufacture for sale of various kinds of medical devices. It also verifies that the firm or manufacturer is manufacturing for sale for some particular year.
The Market Standing Certificate shall be valid for one year from the date of issuance or until the license expiration date, whichever comes first.
This is to certify that M/s.__________________________________________________ are holding license No. _______________valid till________ for manufacture for sale of various kinds of Medical Devices. It is further certified that the firm is manufacturing for sale, ________________________ for the last three years ______, ________, and ________.
State Drug Controller,
Certifying & Licensing Authority
Directorate General Health Services
Manufacturers with active licenses to produce medical devices for sale or distribution must submit an application to the State Drug Controller of the Central Licensing Authority of the Directorate General Health Services.
Covering Letter – The purpose of the application should be made crystal apparent 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.
A legitimate copy of the Central Licensing Authority’s license authorizing the manufacture of medical devices for sale, distribution, or import, as well as the license’s approved product list.
Bills of Entry and Import Information (if an import) over the last three years for the products in question.
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.
Products that need a Market Standing Certificate list (in compact Disc also).
The state drug controller of the certifying & Licensing Authority of the directorate general health services who has issued the license shall issue the market standing certificate.
