Federation of Indian Chambers of Commerce and Industry (FICCI) is organizing a two-day workshop on April 23 and 24, 2010, at FICCI, New Delhi with an objective to create an awareness and discuss existing regulations for medical devices as well as the proposed regulatory system exclusively for medical devices. 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 would 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: implementation and compliance; and proposed comprehensive regulatory framework for Medical Devices
The four workshops planned specifically to address medical devices are as follows – medical devices and invitro diagnostic- definition and risk based classification; design, development, clinical evaluation and risk analysis; 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.