Registration of Medical Devices by Manufactures and Importers

Timeline:

Notification Name	Date
Chapter IIIA - Registration of certain medical devices	10 February 2020
Amendment to Medical device definition	10 February 2020
Registration and Labelling Requirements for Medical devices	18 September 2021
Guidance Document	21 September 2021
Amendment in Chapter IIIA rule 19B-19E	12 October 2021
Unique Device Identification of medical device	31 December 2021
Rule 43A - Suspension and Cancellation of license	18 January 2022
Further amendment in Rule 19B-19E	18 January 2022
Public Notice - BIS Standards	01 February 2022

In 2020, the Indian Government via notification dated 10 February, 2020 brought about a change in law to the effect that manufacturers and importers of all medical devices other than the 37 categories of medical devices have to obtain registration 'voluntarily' before October 1, 2021.

The notification inserted a new chapter - IIIA as 'Registration of certain medical devices' which inserts Rule 19A - 19E dealing with registration of medical devices by manufacturers and importers and its process. Further via notification dated 11 February 2020 a new expanded definition of medical devices was inserted to cover a large scope. Thus from April 1, 2020, medical devices that meet the definition given in the notification will be regulated as drugs under the DCA and MDR.

A period of 18 months w.e.f 1st April 2020 i.e till 30.09.2021 was provided for registering all the four classes of medical devices. This shall be followed by a 'mandatory' registration within 12 months for the Class A and B devices and 24 months for the Class C and D medical devices.

Accordingly the revised dates for mandatory registration according to the public notice issued by CDSCO dated 18 September 2021 are as follows:

• Class A and B medical devices - 30 September 2022
• Class C and D medical devices - 30 September 2023

Thus after the respective dates all the class four medical devices will fall under the licensing regime. Those manufacturers and importers who are unable to obtain registration before October 1, 2021 would have to either stop business of said medical devices till they obtain the requisite registration, or risk facing penal consequences of violating DCA and MDR.
The CDSCO has issued numerous notices between July 12, 2021 to September 27, 2021 specifying the risk classification for medical devices.

The Risk Classification Notices categorize the medical devices into classes A to D in ascending order of risk. The devices are categorized as low risk, low-moderate risk, moderate-high risk, and high risk respectively. This classification is based upon the intended use of the device, risk associated with the use of the device, and the other parameters specified in the First Schedule of MDR.

The Medical Devices Rules Amendment (April 2020) makes two significant adjustments to MDR.

1. The addition of a new chapter to allow producers and importers to register Newly Notified Medical Devices as mentioned above.
2. The 37 categories of existing regulated or notified medical devices established under the new chapter are exempt from the registration requirement.

The CDSCO on further amendment via notification dated 12 Oct, 2021 amended Rule 19B(2) hereby inserting the point of inclusion of ISO Certificate and provisional registration in lieu of it till 31st May 2022. Further via notification dated 18 Jan, 2022 the date for providing an undertaking for compliance with ISO certification and getting a provisional registration was extended to 28th feb, 2022 (earlier one was 30th Nov, 2021).

The registration process would require submission of name and address of the company as also the address of the manufacturing sites, device details, ISO 13485 certificates etc. The ISO 13485 certification is kept as a pre-condition for registration to ensure that indigenous medical device manufacturers are ready to access and compete in the world market and would be treated at par with leading global companies.

Along with these details, the importers would also have to furnish a free sale certificate from the intended country of origin for a particular medical device. Since registration with the government-designated portal is to be followed up with an application for license with the Central Drugs Standard Control Organisation (CDSCO), it ensures a sort of a double-checking of the credentials of the manufacturers.

The Medical Devices Compliance Orders state that existing manufacturers/importers of the Notified Devices may continue their manufacture/import activities up to June 30, 2022 provided they have already made an application for the relevant license to the CDSCO before April 18, 2021. From July 01, 2022 importers/manufacturers are required to operate with a license and print the license number on the label of the Regulated Device.

All incomplete applications submitted before April 18, 2021 are required to be completed with necessary documents before March 31, 2022. The Order also requires the Licensing Authority to dispose of applications within three months of the date of receipt of the application.

Registration Certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device

Timeline

Notification	Date
Insertion of 87A-87I and Form MD-41 via Medical Devices (Amendment) Rules, 2022	09 February 2022

The Ministry of Health and Welfare via Medical Devices (Amendment) Rules, 2022 inserted in rule 87, at the end of sub-rule(1), (1)A which states that anyone who intends to sell medical devices shall obtain registration certificate as per rule 87A-87D which are also inserted via same amendment notification.

It introduces a new form MD- 41 which is to be filed for registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device before the state licensing authority.

These new rules also deal with the compliance requirements for a registration certificate, its validity, suspension and cancellation. It also provides the procedure for appeal before authority in case of rejection of registration certificate with the timeline. Authors Note:
This note is divided into two chapters:

1. Chapter 1 - Registration for Manufactures and Importers
2. Chapter 2 - Sale of Medical devices

I have tried to cover all the recent primary sources i.e notifications, amendments, notices and FAQs issued on this behalf and secondary sources i.e online web articles and news reports for further reference.