Introduction: Indian MDR – Deadline Approaching for Non-Notified Medical Devices

This article deals with the Indian MDR Deadline Approaching for Non-Notified Medical Device Registration. The Central Drugs Standard Control Organization (CDSCO) is the Indian Advisory Body for Pharmaceuticals and Medical Devices wherein all Notified Medical Products are regulated by them. The responsibility lies with the Drugs Controller General of India (DCGI) under the CDSCO for the Indian MDR. The CDSCO is responsible for the  Indian MDR, regulation Drugs, Cosmetics, IVD’s and Medical Devices, control over the quality of Imported Devices, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. Manufacturers can leverage their approvals in the US, Canada, Europe, Australia or Japan for the Indian MDR. As per CDSCO’S Rule effective April 1, 2020 all medical devices requires registrations. As per the rule, all Medical Devices are classified into two major classes 

  1. Notified Medical Devices
  2. Non-Notified Medical Devices

Until now, only Notified Medical Devices Required Registration in India. There are 37 classes of Medical Devices under the Notified Rule. However, as per the rule from April 1, 2020, all Medical Devices have been roped in for Registration.As per the gazette notification, effective April 1, 2020, the medical devices that fall under the following definition will be regulated as “drug” – 

All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception.

Any Medical Device Falling which does not fall under the 37 mentioned Notified Medical Device has to undergo the process of Non-Notified Product Registration. The process to obtain registration for non-notified devices would be as follows- 

Step 1 : Check Gazette Notification

When a manufacturer decides to get their products registered in India, he/she must review the CDSCO’s gazette notifications to understand if the product falls under a notified or non-notified category.

Step 2 : Appointment of Indian Agent

The manufacturer must appoint an Indian Agent who will handle the submission of documents and help obtain the registration number for a non-notified device. 

Step 3 :  Compilation of Documents

The importer will have to compile the following documents – 

  1. Name of the company or firm or any other entity importing the medical device,  specification and standards of the particular medical device 
  2. Details of medical device
  3. Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device 
  4. FSC – Country of Origin 
  5. Undertaking signed by the importer stating that the information provided by the applicant is true and authentic

Step 4 : Process and Verification

Once the documents are submitted, the CDSCO will give a registration number for the particular medical device. The importer will then have to mention the registration number on the label of the medical device. The Central Licensing Authority will verify the documents at any point of time and investigate quality or safety related failure or complaints.  If the manufacturer fails to comply with the provision of the new rules, the Central Licensing Authority may cancel the registration number or suspend it for a period of time. 

Step 5 : Importation 

The manufacturer can import their device into the country only via the Authorized Indian Agent.

What happens if a Manufacturer Fails to Comply?

Every Manufacturer will have to display the Registration Number on the Importer Label while exporting to India. This requirement is not linked to the deadline for registration (October 1, 2021). If the importer fails to obtain registration by October 1,2021 then they will not be able to continue its import into India. All the Medical Devices must have the label with the Registration Number stuck in order to prevent the consignment being confiscated by DCGI. Any violation to obtain medical device registration including failure to obtain registration or license before the deadline may result in fine or imprisonment. 

Conclusion

As per the Medical Device Amendment Rules (MDR 2020)  in India, the enforcement of Product Registration for all Medical Devices commences on 1st October 2021. The grace period to register Medical Products is till 30th September 2021. It is advised that the companies work towards obtaining the Registration Certificate now to avoid last minute delays. Also to mention that, if the manufacturer fails to comply with the new rules, continued sales will not be permitted. 

How can Morulaa Help 

Morulaa HealthTech as successful regulatory consultants has delivered high level professionalism and quality towards our clients.We at Morulaa can help you learn more about the Indian MDR. Subscribe to our Website for Regulatory Consultancy wherein you learn about the Latest Rules and Indian MDR. Contact Harshita Gupta for additional consultation or information.


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