Last Updated on January 19, 2024 by The Health Master
The Union health ministry will soon classify non-notified medical devices like adhesive drapes, gowns and coveralls under Class A, and surgical drapes and non- notified in-vitro diagnostic (IVD) as Class B medical device for its effective regulation.
The Drugs Controller General of India (DCGI) has asked all stakeholders and associations for comments and suggestions on classifying non-notified medical devices by October 3, 2020 for its effective regulation under the New Medical Device Rules (MDR-2017). As per a DCGI notice, stakeholders suggestions have been sought with reference to the earlier gazette notification, published on February 11, 2020 which stipulated that the medical devices will be regulated in phase-wise manner.
IVDs are classified under Chapter II, Rule 4, Sub-rule (2) of MDR 2017 on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely:—(i) low risk -Class A; (ii) low moderate risk-Class B; (iii) moderate high risk-Class C; (iv) high risk-Class D.
This is with reference to gazette notification, published on February 11, 2020 which stipulated that the medical devices which are covered under the definition will be regulated in phase-wise manner. In accordance to medical device rules (MDR-2017) Chapter II, Rule 4 (3) the Central Licensing Authority (CLA) needs to classify such medical devices as per risk based approach. In order to facilitate the process to classify all such medical devices including IVD medical devices, the devices are divided into 03 categories like IVD analyzer, IVD Instrument and IVD software and examined as per the classification followed internationally and First Schedule of MDR-2017.
Also read: Govt appoints Das as SDC, Mamina to continue as SLA: Odisha
As per DCGI, all concerned associations/stakeholders are requested to forward their comments at e-mail ID cdsco.class.mdgmail.com within 30 days from date of issue.
DCGI had recently issued an advisory to the manufacturers to voluntarily register on Central Drugs Standard Control Organisation (CDSCO)’s medical device online portal—cdscomdonline.gov.in. The registration will secure the manufacturers a registration number from the CDSCO, which will serve as a quality management system benchmark. PPE coverall is an important medical device for healthcare workers handling COVID-19 patients.
According to industry sources, as of today barely 25 manufacturers have ISO 13485 certification. Union health ministry on February 11, 2020 had notified all medical equipment used on humans or animals as “drugs” under Section 3 of the Drugs and Cosmetics (D&C) Act, with effect from April 1, 2020 to ensure that all medical devices including PPE kits meet certain standards of quality and efficacy.
In order to ensure patient safety at the point of care, experts had earlier also recommended that gloves, coveralls and masks intended for medical use should conform to Bureau of Indian Standards (BIS) as per MDR 2017. As of today, personal protective equipment (PPE) which include gloves, coveralls, goggles and masks are not being effectively regulated as medical device manufacturers have yet to get themselves registered voluntarily on the portal-cdscomdonline.gov.in. as per the mandate of MDR- 2017.
The DCGI has also recently issued an advisory to the PPE manufacturers to voluntarily register on the portal. PPE coverall is an important medical device for healthcare workers handling COVID-19 patients. Since MDR 2017 uses concept of notified bodies, certificates of conformity from any notified body of Central Drugs Standard Control Organisation (CDSCO) should be acceptable with National Accreditation Board for Certification Bodies (NABCB) logo,” recommended Anil Jauhri, former CEO, National Accreditation Board for Certification Bodies (NABCB).
To promote the supply of quality PPEs during the ongoing pandemic, BIS has also permitted relaxation in its norms of having in-house testing facilities for the following PPEs like filter half masks to protect against particles of Class FFP2 as per IS 9473:2002, surgical face masks as per IS 16289:2014 and eye protectors as per IS 5983:1980.
Those domestic manufacturers who are interested in applying for a BIS licence may register themselves and submit their application online through BIS website ‘www.bis.gov.in’.
We would suggest that BIS shall extend the same to all PPE components including surgical gowns. There is also an urgent need for complying with QMS systems like ICMED/ISO 13485 to be made mandatory for stricter controls of quality output from manufacturers,” explained Sanjiv Relhan, chairman, Preventive Wear Manufacturer Association of India (PWMAI).
Rajiv Nath, forum coordinator, Association of Indian Medical Devices Industry (AiMeD) said, “AiMeD has also been initiating steps to ensure that the new PPE manufacturers get trained to ICMED/ ISO 13485 voluntary quality assurance (QA) certification as well negotiated with BIS with help of Union ministry of textiles (MoT) and department of pharmaceuticals (DoP) to provide relaxation on temporary basis to get third party testing done.”
The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.
