CDSCO To Switch Permanently On Online Registration For Medical Device Manufacturers And Importers

Following promulgation released by the Ministry of Health & Welfare in October 2019. Amendments have been made to the Medical Device Rules, 2017 relating to the registration procedure of medical devices.

These amendments are an addition to the Chapter III of Medical Device Rules, 2017 and will hence be classified as Chapter IIIA of these rules. These have already come into effect on 1^st April 2020 and may be called Medical Device(Amendment) Rules, 2020.

According to the new rule, medical devices referred in sub-rule(1) shall be registered with the Central Licensing Authority through an identified online portal established by CDSCO for this purpose.

This will be known as the “Online System for Medical Devices” and will allow the manufacturers or importers of medical devices to obtain registration numbers online.

The required documents for the submission of such applications are the same as before and have to be uploaded in scanned digital format to the portal.

Some common documents to be submitted on the portal include:

●     Identification details of the applicant and manufacturing facility

●     Full details of the medical device

●     Certificate of compliance w.r.t ISO 13485 accredited by NAB or International Accreditation Forum

●     Undertaking signed by the applicant

An extra document to be submitted by an importer of medical devices will be a copy of ‘free sale certificate from the country of origin”.

After furnishing these details along with the application form on the online portal. A registration number will be generated by the system. The manufacturer/importer must mention this registration number on the label of the medical device.

However, devices mentioned in the annexure of the eight schedules have been exempted from online registration until further directions. Furthermore, these exemptions will cease after some times depending upon the class of medical devices(30 months for Class A & B and 42 months for Class C & D)

It is important to note here that online registration under this new chapter is on a completely voluntary basis for a period of eighteen months, starting from 1st April 2020. However, this online registration will become a mandatory part of the medical device registration in India for all manufacturers and importers after the stipulated duration.

Benefits of this new step

As more and more processes are going online these days. The Indian medical device regulations must also conform to this fast-paced world of digitalization. Especially when the markets are globalized and India is a huge market for pharma companies.

This online initiative from CDSO will ease the already cumbersome process of medical device registration. While helping manufacturers and importers and encouraging them to bring and market more advanced and latest devices.