Voluntary 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 nonregulated medical devices. As the name suggests, these devices are not yet regulated by CDSCO, as it is according to the Medical Device Rules 2017.

The time period for voluntary registration:- For non-regulated medical devices, CDSCO has introduced a scheme of voluntary/compulsory registration. As per this scheme, registration is mandatory on a voluntary basis for a period of eighteen months from the date of this notification (ie till September 2021) and thereafter. The manufacturer or importer shall mention the registration number so obtained on the label of the medical device.

Relaxation period limited by the government: - After a period of thirty months (ie September 2022) for low risk - category A and low medium risk - category B and forty-two months (ie September 2023) such exemption will expire. Medium-High Risk – Category C and High Risk – Category D devices, respectively from the date of this notification i.e. such non-regulated medical devices shall be regulated as per MDR 2017 after the above time period.

After that, it will be mandatory to fulfill all the requirements mentioned in MDR 2017, that is, for manufacturing or selling of medical devices or in-vitro medical devices or for importing for distribution.

What Are The Documents Required For Voluntary Registration?

• ISO 13485 Certificate

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  Free Sales Certificate (in case of import)

What is the government fee for voluntary registration?

There is currently no government fee for voluntary registration of a non-regulated medical device.

How long does it take for voluntary registration?

If the customer has documents like ISO 13485 and Free Sales Certificate (in case of import) available, we help to do voluntary registration within 24 hours.

Importance of voluntary registration during import

Voluntary registration is required for the import of any type of non-regulated medical device. An importer presents a registration number or a file number generated after voluntary registration to the Customs Officer.

What do I have to do after the voluntary registration period is over?

Contact us for voluntary registration of your medical device, whether you are an importer or a manufacturer. We assure to give you the registration number at the earliest, no matter how complicated your case may be. We provide better services at an economical price.

ELT Corporate and Medical Device Registration:

ELT is renowned for its services in all areas of scientific licensing from Corporate Legal Metrology, BIS, Drugs & Cosmetics, Medical Devices, Food Safety, and Environment Safety to New Technology Patents. ELT Corporate has a team of Advocates, Engineers, M.Pharma, Chartered Accountants, and Company Secretaries. With such a unique combination of talent under one roof, it has always been a hassle-free wonderful experience for large 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.

How We Can Help You With Medical Device Registration?

• We help our clients to communicate with government portals and ministries to get licenses.

• In short, we assure our clients about any regulatory requirement for the Medical Device in India.

• We help our clients to develop all the documents whether it is Device Master File, quality manual, or management responsibility as the case may be.

• We help our clients to maintain various records which are mandatory as per MDR 2017.

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  We provide expert service in the development of Quality Assurance Laboratories.