Mumbai : Even as registration of Class A and Class B medical devices with the Central Drugs Standard Control Organization (CDSCO) became mandatory from October 1, 2021, it has received a lukewarm response from device manufacturers. Taking serious note of this, Maharashtra food and drug administration (FDA) has directed manufacturers of medical devices falling under Class A and Class B in the state to speed up registration with the CDSCO.
The deadline for voluntary registration of Class A and Class B medical devices with the regulator ended on September 30, 2021 and registration became compulsory from October 1, 2021. Manufacturers are required to complete mandatory registration with the CDSCO by September 30, 2022. It has come to the notice that a significant number of device manufacturers in the state are yet to register with the CDSCO.
Medical devices categorised into Class A and Class B will fall under license regime with effect from October 1, 2022.
According to a circular issued by Maharashtra FDA recently, action will be initiated against the manufacturers of Class A and Class B medical devices for failing to register with the online portal of CDSCO within the stipulated time frame.
As per Medical Devices Rules 2017, all medical devices have been classified into four different categories– Class A, Class B, Class C and Class D. Any company which intends to manufacture these devices for sale or distribution is required to apply for a manufacturer’s license with CDSCO.
Class A and Class B devices are classified as low risk and moderate risk devices. The license for manufacturing these devices can be applied and obtained at the state licensing authority. The application is made using form MD-5 whereas the permission is granted through form MD-6.
Class C and Class D devices are regulated by CDSCO according to the provisions of the said Rules.
According to the ministry of health and family welfare’s notification on February 11, 2020, the medical devices were under voluntary registration scheme from April 1, 2020 till September 30, 2021. From October 1, 2021, Class A&B medical devices will be under compulsory registration scheme up to September 30, 2022 and Class C&D medical devices will be under compulsory registration scheme up to September 2023. After the compulsory registration period, these classes will respectively move to the licensing regime.
“Accordingly, all the medical devices manufacturers in the state are directed to complete the procedure of mandatory registration within prescribed time limit. The medical devices manufacturers of Class A and Class B are hereby intimated that if the mandatory registration is not completed within the stipulated time period, further necessary action will be initiated by the department,” said DR Gahane, joint commissioner (headquarter), Maharashtra FDA.
The notified medical devices were regulated in accordance to the provisions of Drugs and Cosmetics Rules, 1945 prior to the publication of Medical Devices Rules, 2017. However, the list of notified medical devices was not exhaustive to cover the entire class of medical devices. The central government has notified the Medical Devices Rules, 2017 in exercise of the powers conferred by Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940 and the said Rules are effective from January 1, 2018. Under the said Rules a large range of preventive care devices, diagnostic devices and therapeutic devices are notified.
