IPC sensitises industry, regulators on medical device quality, safety and testing

The Indian Pharmacopoeia Commission (IPC) under the Union health ministry organized two-day training workshop recently at Central Drugs Standards Control Organization (CDSCO) zonal office in Chennai to sensitize medical device manufacturers, importers, regulators, healthcare practitioners (HCPs) and bio-medical engineers about the medical device quality, safety management and testing as per the Medical Devices Rule 2017. 

The main objective of the workshop was also to encourage medical devices entrepreneurship and extend technical support to start-up on medical devices. 

The two-day training workshop covered relevant topics like medical devices quality management system, risk management, adverse events reporting tools and other related areas. Training programme was attended by more than 75 participants from different parts of the country including industry, HCPs, government and CDSCO officials. Experts from Bureau of Indian Standards (BIS), CDSCO, IPC and Industries were invited as speakers and trainers to share their experiences in promoting medical devices standards and safety.

Speaking on the event, Dr G N Singh, Secretary-cum-Scientific Director, IPC complimented the stakeholders for coming together for very important cause. He reiterated 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 (CDTL), Chennai for his outstanding contribution to pharmaceuticals and medical devices testing and standardization, implementation of Indian Pharmacopoeia standards for promoting public health.

The event sensitized the gathering on Materio-vigilance Programme of India (MvPI) functioning and IPC activities/services. It 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 national co-ordination centre (NCC)-MvPI to ensure effective dissemination or coordination with the matters related to medical devices safety.

Industry representatives expressed their interest to conduct a training programme on Causality Assessment of medical device adverse event (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 particularly in- vitro diagnostics (IVDs) to ensure their safe use. 

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=115749&sid=1