CDSCO Begins Training of Gujarat, Maharashtra FDA Medical Device Inspectors for implementation of New MDR

The Central Drugs Standard Control Organisation (CDSCO) has begun training Medical Device Officers from Gujarat and Maharashtra Food and Drug Administration for the proper implementation of the new Medical Device Rules (MDR)-2017. The new MDR 2017 now requires medical device companies that manufacture all A, B, C, and D classes of devices to register until the deadline of October 1, 2023. This will pave the path for the new MDR licencing regime to be implemented effectively. "In the state of Maharashtra, approximately four training sessions have been held for 80 notified medical device inspectors who also serve as drug inspectors."

According to a top Maharashtra FDA official, the training "equips medical device inspectors on performance of medical devices as well as aspects like validation, documentation, risk based assessment, and quality management system (QMS) among others." The Maharashtra FDA has authorised all 80 drug inspectors to act as medical device inspectors under the Drugs and Cosmetics (D&C) Act in a phased manner. The Gujarat Food and Drug Control Administration (FDCA) has also informed all 89 drug inspectors that they have been designated 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 medical device industry has mostly gone unregulated. Under the Drugs and Cosmetic (D&C) Act of 1940, the Union Health Ministry drafted the MDR, 2017 for a phased comprehensive regulation of medical devices, focusing on quality, safety, and efficacy. The sector is expected to grow in market size from the present US$ 11 billion to US$ 50 billion by 2025.