CDSCO launches online service for medical devices, diagnostics in Sugam portal

CDSCO launches online service for medical devices, diagnostics in Sugam portal

Mumbai, November 21, 2017:

With an aim to facilitate single window clearance for medical device and diagnostics industry, the Central Drugs Standard Control Organization (CDSCO) has launched online service for grant of import, manufacture, clinical investigation, sale and distribution licences of medical devices and diagnostics in Sugam portal.


The online solution for application, submission, processing and grant of permission to medical device and diagnostics was launched by CDSCO recently as per Medical Devices Rules, 2017 which will be effective from January 1, 2018.


All applications for import, manufacture, sale or distribution and clinical investigation, whether to be examined by the DCGI or State Licensing Authority, will have to be made through a single online portal of the CDSCO i.e. Sugam portal. The applicants seeking renewal of licences are also required to submit application online.


Once 2017 Rules becomes effective, all licenses and registrations for medical devices issued previously under the Drugs and Cosmetics Rules will be valid until July 31, 2018 or until they expire, whichever is later. After expiration date, all existing licensees are required to get a license issued under the 2017 Rules.


The licenses issued under the 2017 Rules are permanent, they will remain valid unless they are cancelled. The licensee is required to pay a prescribed license retention fee every five years to avoid cancellation of license.


The 2017 Rules has removed need of registration certificate for registration of a foreign manufacturer, its manufacturing site and the products. Currently they need to make two separate applications (registration and import license) to import and market products in India. After commencement of the Rules 2017, the foreign manufacturer needs to appoint an authorized agent in India and apply for an import license through it to import and market products in the country. The applicant will get import license in nine months.


All licenses for sale of drugs other than homeopathic medicines issued prior to commencement of 2017 Rules will remain valid for sale of medical devices as well.


As per 2017 Rules, medical devices have been divided into four categories-- A, B, C, D based on risk associated with them.


The State licensing authority will assess the application for manufacture of Class A or Class B medical device and DGCI will assess the application for manufacture of Class C or Class D medical device.