Medical Device Registration Goes Completely Online With New Portalby Divya S. Content Writer
The world is now supported and connected by the internet like never before. Everybody from large corporations to small business owners uses the power of the internet to conduct their operations. In recent times, the GOI has taken long steps to match the fast-paced work procedures on the internet.
In resolve to this, the GOI now plans on shifting the registration of new medical devices totally online[NM2]. These new rules shall be called the Medical Device (Amendment) Rules, 2019 and feature the addition of Chapter IIIA after Chapter III of the Medical Device Rules, 2017.
The new rule will be applicable to all devices notified under clause (b) of section 3 of the Act except
the medical devices and devices specified in the Annexure of Eighth Schedule of these rules.
According to this new rule, the medical devices referred to in sub-rule(1) shall be registered with the Central Licensing Authority through the identified online portal established by CDSCO. The portal is known as the “Online System of Medical Devices”.
For the registration of a new medical device, the manufacturer shall upload all the relevant information (as mentioned in sub-rule (2)) to the online portal. This information includes the name &address of the company, details of medical device, certificate of compliance and an undertaking.
Once all the information has been furnished by the applicant, the portal will generate a registration number. This number shall be printed on the label of the medical device.
The process is similar to the import of medical devices. However, a free sale certificate from the country of origin will be an extra document required for online registration.
The medical devices and devices which have been exempted from this online registration process have been listed in an Annexure of the eight schedules of this new chapter. However, this exemption shall cease to exist for different classes of medical devices after a certain period of time for each, starting from the date of this notification.
It is also important to note that the central licensing authority can at any time, cross verify the documents and may cancel the registration if it deems fit.
Medical Device Registration India under this new rule is on a voluntary basis for a period of eighteen months. But using the online portal for registration will be mandatory after the specified deadline.
This is a commendable step taken by the GOI. Since offline registration takes too much time and effort due to the slow processing of documents. This step will not only boost the registration process but will also encourage new manufacturers and entrepreneurs to enter the market and play their part.
Created on Jan 17th 2020 06:07. Viewed 162 times.