Mumbai : The Central Drugs Standard Control Organisation (CDSCO) has started conducting training of Gujarat and Maharashtra Food and Drug Administration Medical Device Officers for effective implementation of new Medical Device Rules (MDR)-2017.
The new MDR 2017 currently requires compulsory registration of the medical device companies which are manufacturing all A, B, C and D classes of devices until the deadline of October 1, 2023. This will further pave the way for effective implementation of the new MDR licensing regime.
“Around 4 training sessions have been held for 80 notified medical device inspectors, who are also serving as drug inspectors in the state of Maharashtra. The training is equipping medical device inspectors on performance of the medical devices besides the aspects like validation, documentation, risk based assessment and quality management system (QMS) among others,” according to a senior Maharashtra FDA official.
The Maharashtra FDA has authorized all 80 drug inspectors as medical device inspectors to regulate all classes of medical devices under Drugs and Cosmetics (D&C) Act in a phase wise manner.
The Gujarat Food and Drug Control Administration (FDCA) has also notified all 89 drug inspectors as medical device inspectors.
“All the 89 medical device inspectors will get exposure to the intricacies of the new MDR with compliances on performance, safety and QMS among others. Gujarat FDCA has also collaborated with National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad and other stakeholders to train the medical device inspectors,” informed Dr H G Koshia, commissioner, Gujarat FDCA.
The new MD Rules 2017 were notified on February 11, 2022 and came into effect from January 1, 2018 onwards in the country. Following the notification, issues related to post grant compliance, data protection, product recalls and product liabilities among others will be implemented effectively towards device or product safety.
State Licensing Authorities (SLAs) have to send applications to the notified bodies for inspections and auditing of Class A and Class B category medical devices towards compliance to the new MD Rules. Class C and Class D categories are audited by the CDSCO independently as per the new MD Rules.
The Central government, after consultation with the Drugs Technical Advisory Board (DTAB) had notified MDR- 2017 effective from January 1, 2018.
As per the Government notification, 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 subject to a mandatory registration scheme from October 1, 2021, until September 20, 2022, and Class C and D medical devices were subject to a mandatory registration scheme until September 20, 2023. Following the mandatory registration period, these classes will then transition to a licensing system.
The medical device sector has largely remained unregulated. The MDR, 2017 were framed by the Union health ministry for a comprehensive regulation of medical devices in a phased manner, especially on the quality, safety, and efficacy aspects, under the Drugs and Cosmetic (D&C) Act, 1940.
The sector is expected to grow in market size from the present US$ 11 billion to US$ 50 billion by 2025.
