Industry experts are satisfied with the relaxation of ISO compliance standards for medical devices for registration with the Central Drug Control Standard Organization (CDSCO) for the transition to the new medical device licensing system under the New Medical Device Rules (MDR), 2017.

CDSCO recently released the Medical Device Amendment Rules drfat, Notice 2021 which grants an extension to the submission of ISO 13485 for the purpose of medical device registration from the previous date of September 30, 2021 to May 31, 2022 towards the transition to the new medical device licensing system as per MDR-2017.

The Medical Device Amendment Rules Draft Notice, 2021, stated that “provided that in the event that the applicant submits, on or before November 30, 2021, the applicant must obtain an ISO 13485 certification on or before May 31, 2022 in lieu of a certification of compliance as indicated To it in Clause (3) of Sub-Rule (2) of Rule 19b, a provisional registration number shall be established which will remain valid until May 31, 2022 or the date on which the applicant obtained such ISO certification, whichever is earlier. Its creation is valid for all purposes.”

According to an earlier notification issued by the Federal Ministry of Health on February 11, 2020, medical devices were subject to the voluntary registration system from April 1, 2020 to September 30, 2021. The registration system is from October 1, 2021 until September 20, 2022, and Class C and D medical devices are subject to a registration system Mandatory until September 20, 2023. After the mandatory registration period, these categories will then move into the licensing system.

“Many medical device manufacturers are relieved by the partial deferral granted to obtain ISO 13485 by May 2022 and to have the registration number affixed to the packaging by that time period,” said Rajiv Nath, Forum Coordinator, the Association of Indian Medical Device Industry (AiMeD) lobbying on behalf of Domestic manufacturers across India:

“However, we are still seeking to reschedule manufacturing licenses for 8 classes of Class C and Class D complex medical devices through August 2023, in line with all other Class C and Class D medical devices as manufacturers and no regulatory compliance verification regime is in sufficient readiness. To enable them to regulate.Only importers will be obligated, this gives them market access advantage over OEMs.A subsequent circular of April 18, 2021 has rescheduled it from April 1, 2021 to October 18, 2021 without any joint willingness to meet this deadline.May be granted Those who are ready to obtain a license this early and can be given rest under the registration system and discussions with these manufacturers to support them by reviewing the infrastructure that the country needs to enable them to demonstrate compliance with conformity.”

“For manufacturers of Class A non-critical, non-sterile medical devices such as non-sterile stainless steel surgical instruments, compliance with a core quality management system such as ISO 9000 has been sought along with a simple self-declaration and checklist. Business continuity is important. He added that regulations do not mean business closure but continuity with more discipline to achieve a higher degree of patient safety than relying only on traditional technical skills and some basic quality checks by businesses run by small-scale industry owners.

While supporting the government move, Pavan Chowdhury, Chairman of the Medical Technology Association of India (MTaI), said: “We appreciate the extension given by CDSCO to provide this certification without causing any delay in the implementation of the registration procedure. This amendment will ensure that the industry, especially the micro-enterprise sector SMEs get more time to comply with ISO 13485 requirements and synchronize with the regulatory framework on deadlines.This will also help to get more time for regulators to reset their administrative procedures to stick to the schedule moving forward.This will also ensure that there is no outage in services And supply important medical devices to Indian patients during these adjustments.
Furthermore, instead of stating that the company “must state the registration number” on the medical device label, Rule 19c requires that the company “must state the registration number” on the medical device label. This has been changed to include a requirement that the manufacturer may, if requested, include the registration number or provisional registration number for a period 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 sub-rule 19D (2) Clause (3), which deals with the registration of medical equipment by importers, stating that an importer can also submit a registration application.

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

Source link

By admin

Leave a Reply

Your email address will not be published. Required fields are marked *