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Voluntary Medical Device Registration

What is the Voluntary Medical Device Registration?

Government Notification:- As per the Gazette Notifications GSR 102 (dated 11 Feb 2020), besides the certain medical devices, rest all are under the category of non regulated medical devices. As the name suggests, these devices are not yet regulated by CDSCO, as it is according to the Medical Device Rules 2017.

Time Period of Voluntary Registration:- For, the non-regulated medical devices, the CDSCO has launched a scheme of Voluntary/ Compulsory Registration. As per this scheme, the registration is on voluntary basis for a period of eighteen months from the date of this notification (i.e. till Sep 2021) and there after it is mandatory. The manufacturer or importer mention the registration number, thus obtained, on the label of the medical device.

Limited Exemption Period by Government:- Such exemption shall cease after a period of thirty months (i.e. Sep 2022) for low risk - Class A and low moderate risk - Class B and after a period of forty-two months (i.e. Sep 2023) for moderate high risk – Class C and high risk – Class D devices, respectively from the date of this notification i.e. such non-regulated medical devices will be regulated as per MDR 2017 after the above mentioned time period.

After that, it shall be mandatory to fulfil all the requirements as mentioned in MDR 2017 to manufacture or to import for sale or for distribution of Medical Devices or In-Vitro Medical Devices.

What are the Documents required for voluntary registration?

  • ISO 13485 Certificate

  • Free Sale Certificate (in case of import)

What is the government fee for the Voluntary Registration?

There is no government fees at present for the voluntary registration of non regulated Medical Device.

How much time does it takes for Voluntary Registration?

If the documents like ISO 13485 and Free Sale Certificate (in case of import) are available with client then, we help to get Voluntary Registration done within 24 hours.

Importance of Voluntary Registration During Imports

Voluntary Registration is necessary for the import of any type of non-regulated medical device. An importer present to the custom officer an registration number or file number generated after the voluntary registration.

What I need to do after the ending of Voluntary registration period?

Contact us for the voluntary registration of your medical device either you are an importer or a manufacturer. We assure to deliver you registration number as soon as possible irrespective of how complex your case may be. We provide better services with economic price.

ELT Corporate and Medical Device Registration:

ELT Corporate is renowned for its services in all the fields of scientific licenses staring from Legal Metrology, BIS, Drugs and Cosmetics, Medical Devices, Food Safety, Environment safety to New Technology Patent. ELT Corporate has a team of Advocate, Engineers, M.Pharma, Chartered Accountants, Company Secretary. With such a unique combination of talent under a single roof, it has always been a hassle-free wonderful experience to the big corporates.

ELT Corporate is one of the best Medical Device Ragistration Consultant in India and always try to provide the best experience to our clients.

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