Online Service For Medical Devices Not Functioning Since Last Year

Despite the fact that an online service for grant of manufacture and sale licenses of medical devices was launched in Sugam portal in November a year ago, not a single application from the concerned stakeholders has been processed as the online platform for medical devices is lying defunct because of technical problems, as indicated by an official.

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

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

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

According to the government’s order, all applications for import, manufacture, sale or distribution and clinical examination, regardless of whether to be inspected by the DCGI or State Licensing Authority, should be made through a single online portal of the CDSCO i.e. Sugam portal.

The applicants looking for a renewal of licenses 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 already under the Drugs and Cosmetics Rules will be valid until July 31, 2018, or until they expire, whichever is later.

After the expiration date, every single existing licensee is 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 stay valid unless they are canceled.

The licensee is required to pay a recommended license permit maintenance expense every five years to avoid cancellation of license. According to 2017 Rules, medical devices have been divided into four classifications – A, B, C, D based on risk related to them.

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


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