The Indian Pharmacopoeia Commission (IPC) under the Ministry of Health and Family Welfare, Government of India, organized two days training programme on management and ensuring safety of medical device on May 2-3, 2019, at Shastri Bhawan, Central Drugs Standards Control Organization (CDSCO) zonal office, Chennai. The objectives of this workshop were to appraise the stakeholders (medical device manufacturers, importers, regulators, healthcare practitioners (HCPs) and biomedical engineers etc.) about the medical device quality and safety management and testing as per the medical devices rule 2017 in the interests of the public; also to encourage medical devices entrepreneurship and to extend technical support to startup on medical devices.
This two days training covers medical devices quality management system, risk management, adverse events reporting tools and other related areas. Training programme was attended by more than 75 participants of PAN India including Industry, HCPs, Government and CDSCO officials. The experts from Bureau of Indian Standards, CDSCO, IPC and Industries were invited as speaker/trainer to share their experiences in promoting medical devices standards and safety.
Dr. G N Singh, Secretary-cum-Scientific Director, IPC while inaugurating the training, complimented the stakeholders for coming together for very important cause. He retreated that IPC is always committed to promote the quality and safety of medical products for the global community. Dr. Singh acknowledged Dr. N. Murugesan, Director, Central Drugs Testing Laboratory, Chennai for his outstanding contribution to pharmaceuticals and medical devices testing and standardization, implementation of Indian Pharmacopoeia standards for promoting public health.
Benefits and Outcome:
- Sensitized the gathering on MvPI functioning and IPC activities/services
- Provided an opportunity to identify and improve the gap areas to enhance the Adverse Events reporting
- Understand tools to integrate vigilance activities with regulatory system, in coordination with AMTZ
- It was decided to constitute a Rapid Voluntary Surveillance Team (RVST) for alerting NCC-MvPI to ensure an effective dissemination/coordination with the matters related to Medical Devices safety-Participants expressed their interest
- Industry representatives expressed their interest to conduct a training programme on Causality Assessment of MDAE and other grey areas in particular to Medical Devices for IPC officials, CDSCO officials and other state regulators
- Government officials and industry representatives were in agreement to develop monograph on medical devices in particular to IVDs to ensure their safe use. Modalities to be worked out.