Even though an online service for grant of manufacture and sale licences of medical devices was launched in Sugam portal in November last year, not a single application from the concerned stakeholders has been processed as the online platform for medical devices is lying defunct due to technical problems, according to an official.

The Central Drugs Standard Control Organization (CDSCO) had launched the online service for grant of import, manufacture, clinical investigation, sale and distribution licences of medical devices to facilitate single window clearance for medical device through Sugam portal.

Centre for Development of Advanced Computing (C-DAC), which has prepared the online Sugam portal for medical devices, is currently sensitising medical device and IVD manufacturers towards registration to the online portal for submissions of various forms, as per the mandate of the new Medical Device Rules.

The online platform for application, submission, processing and grant of permission of medical device and diagnostics were aimed at implementing new Medical Device Rules, 2017 which are effective from January 1, 2018.

As per the government’s mandate, 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 be submitted through online application mode.

Once the Medical Devices Rules 2017 become 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 new Medical Device Rules 2017.

The licenses issued under the Medical Device Rules 2017 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.

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 CDSCO will assess the application for manufacture of Class C or Class D medical device.