To ensure that quality medical devices are provided to patients, the state government and the Pune Food and Drugs Authority (FDA) have issued a letter to all medical device manufacturers to make sure that they register themselves and get a license before September 2022. Those who fail to get registered within the stipulated time will face action under the Cosmetics and Drugs Act and the Medical Devices Rules, 2017. The registration of medical devices ranging from cotton wool rolls to CT scan units will ensure that the medical devices supplied are as per ISO rules.
S B Patil, joint commissioner, FDA, Pune division, said, “Under the Act passed in 2017, it is mandatory for all medical device manufacturers to be registered under the said act. This will ensure that all medical devices are registered and supplied as per the ISO mark. Since 2017, we have had about 22 manufacturers who have got their license. The act covers about 352 devices under the A, B, C and D categories which range from as small as cotton wool and catheters to complex CT scan units. All devices used for diagnosis and treatment are included in the act. Those who do not register by September this year will face action for violation of the said act and also the Cosmetics and Drugs Act.”
Prior to the Medical Devices Rules, 2017, notified medical devices were regulated as per the provisions of the Drugs and Cosmetics Rules, 1945. However, the list of notified medical devices was not exhaustive enough to cover the entire class of medical devices. The central government notified the Medical Devices Rules, 2017, in exercise of the powers conferred by sections 12 and 33 of the Cosmetics and Drugs Act, 1940 and the same have been effective since January 1, 2018. Under the said rules, a large range of preventive care-, diagnostic- and therapeutic- devices have been notified. The Medical Devices Rules, 2017, have also introduced a risk-based classification for regulation and classified the medical devices as low risk (Class A), low moderate risk (Class B), moderate high risk (Class C) and high risk (Class D). Class A and B devices are regulated by the state licensing authority while Class C and D devices are regulated by the central licensing authority as per the said rules.
As per the state government notification, medical devices’ manufacturers should be registered with the central licensing authority through the online portal established by the Central Drugs Standard Control Organisation (CDSCO) for this purpose by a notification dated February 11, 2020. According to the notification dated February 11, 2020, registration will be on a voluntary basis for a period of 18 months from the date of notification after which it will be mandatory. Accordingly, the 18 month voluntary registration period ended on September 30, 2021. Thereafter according to the guidance document published by CDSCO on September 21, 2021, it has been intimated that the voluntary registration period of 18 months for Class A and B medical devices will be followed by a mandatory registration period of 12 months namely up to September 30, 2022. Hence with effect from October 1, 2022, the medical devices under Class A and B will fall under the license regime.
Accordingly, all medical devices manufacturers in the state have been directed to complete the procedure of mandatory registration in the prescribed time limit. Manufacturers of Class A and B medical devices have been intimated that if the mandatory registration is not completed within the stipulated time period, further necessary action will be initiated by the department. Hindustan Times