Industry express relief over relaxation of ISO compliance norms for medical devices to register with CDSCO

Many of the manufacturers of medical devices are relieved with the partial reprieve given of attaining ISO 13485 by May 2022.

CDSCO, ISO 13485, registration, medical devices, licensing regime, draft Medical Devices Amendment Rules, 2021 notification
According to an earlier notification issued by the Union Health Ministry on February 11, 2020, medical devices were subject to a voluntary registration scheme from April 1, 2020 to September 30, 2021.

Industry experts have expressed relief over relaxation of ISO compliance norms for medical devices to register with Central Drugs Standard Control Organisation (CDSCO) towards transitioning into the new medical device licensing regime in accordance with new medical device rules (MDR), 2017.

CDSCO recently released a drfat Medical Devices Amendment Rules, 2021 notification giving an extension for submission of ISO 13485 for the purpose of registration for medical devices from the earlier date of September 30, 2021 to May 31, 2022 towards transitioning into the new medical device licensing regime as per MDR-2017.

The draft Medical Devices Amendment Rules, 2021 notification stated, “Provided that in case the applicant submits, on or before November 30, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the May 31, 2022 in lieu of a certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19B, a provisional registration number shall be generated which will remain valid up to the May 31, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.”

According to an earlier notification issued by the Union Health Ministry on February 11, 2020, medical devices were subject to a voluntary registration scheme from April 1, 2020 to September 30, 2021. Class A and B medical devices were then be subject to a mandatory registration scheme from October 1, 2021, until September 20, 2022, and Class C and D medical devices be subject to a mandatory registration scheme until September 20, 2023. Following the mandatory registration period, these classes will then transition to a licensing system.

“Many of the manufacturers of medical devices are relieved with the partial reprieve given of attaining ISO 13485 by May 2022 and of labeling of registration number on the packaging by that time period. The Covid related disruptions had challenged many manufacturers to seek this certification,” said Rajiv Nath, Forum Coordinator, Association of Indian Medical Devices Industry (AiMeD) that lobbies on behalf of the domestic manufacturers all over India.

“We however still do seek re-scheduling of manufacturing licenses of 8 categories of complex Class C & D notified medical devices to August 2023, in line with all other medical devices in Class C & Class D as manufacturers nor is the regulatory compliance verification system in adequate preparedness to enable them to be regulated. Only the importers will be compliant and this gives them a market access advantage over Indigenous manufacturers. The subsequent circular of April 18, 2021 rescheduled this only from April 1, 2021 to October 18, 2021 without any joint preparedness to meet this deadline. Those who are ready to get licensed may be given this earlier and rest may be given under registration system and discussions held with these manufacturers to support them by reviewing what infrastructure country needs to enable them to prove conformity compliance,” stated Nath.

“For manufacturers of non-critical class A, non-sterile medical devices like stainless steel non sterile surgical instruments a more basic Quality Management system compliance like ISO 9000 has been sought along with a simple self-declaration and checklist. Business continuity is important. Regulations don’t mean closure of business but continuity with more discipline to attain higher degree of patient safety than reliance on only traditional technical skills and some basic quality checks by micro size industry owner managed companies,” he added

While supporting the Government move, Pavan Chaudhary, Chairman, Medical Technology Association of India (MTaI) said, “We appreciate the extension provided by CDSCO for the submission of this certificate without causing any delay in the implementation of the registration procedures. This amendment will ensure that the industry, especially the MSME sector, gets more time to comply with the requirement of obtaining ISO 13485 and sync themselves with the regulatory framework within the deadlines. This will also help get some more time for the regulators to recalibrate their administrative procedures to stick to the schedule moving forward. This will also ensure that there is no disruption of services and supply of critical medical devices for the Indian patients during these adjustments.
Furthermore, instead of the provision that the firm “must mention the registration number” on the label of the medical device, Rule 19 C requires that the company “shall mention the registration number” on the label of the medical device. This has been changed to include the requirement that the manufacturer may, if requested, include the registration number or provisional registration number for a period of up to May 31, 2022. After this date, all registration holders will be required to include the registration number on the label.

The proposed regulation also added a provision and explanation to Rule 19D sub rule (2) item (iii), which deals with the registration of medical equipment by importers, stating that the importer can also submit a registration application.

Sudish Sharma, Executive Partner of Lakshmikumaran Sridharan Attorneys added, “Regulators across industries have given temporary relaxation related to corporate compliances during Covid-19 pandemic. The idea of extending the due date for obtaining certificate of compliance with respect to ISO 13485 standard and bringing a mechanism for provisional registration with CDSCO through the draft Medical Devices (Amendment) Rules, 2021 is a welcome measure amidst the Covid-19 pandemic in the country. This will give more flexibility to the medical device industry to ensure regulatory compliance.”

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