In light of the increasing importance of medical devices and invitro diagnostics in today’s healthcare, regulations are critical for patient safety and a thriving industry. Indian government along with the industry has been working towards evolving robust regulations as well as learning from international standards and practices.
With an objective to create an awareness and the need for a dedicated comprehensive regulatory regime for medical devices,Federation of Indian Chambers of Commerce and Industry (Ficci) in collaboration with Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare is organizing a two-day workshop on June 11 and 12 in New Delhi. It will further disseminate information on current regulations and process of compliance. This programme is in line with Ficci medical device forum’s activities towards making Indian medical device industry globally competitive.
The workshop will have speakers from European Commission- Directorate General for Enterprise and Industry, Cosmetics and Medical Devices, US FDA, Global Harmonization Taskforce, as well as trainers from abroad, who will be sharing their experience on framing and implementing regulators for medical devices.
Key topics of discussion include – role of stakeholders in ensuring robust regulations for a thriving industry; current regulations: challenges and issues in compliance; and proposed comprehensive regulatory framework for medical devices.
Sessions planned specifically for medical devices are – Medical Devices and Invitro Diagnostic- Definition and Risk Based Classification; Design, Development, Clinical Evaluation and Risk analysis; Bio- compatibility; Quality Audits; and Vigilance Reporting
This programme will also see a debate on “Suitable Regulation in India: Towards Harmonization and Law of the Land” between Regulators from India, EU, US & Industry.