Webinar: Understand India's New Medical Device Regulations 2017
Today, we have two experts from India, Mr. Satyam Qatari and Mr. Josh Maurya, who bring extensive experience in quality assurance and regulatory affairs in the medical devices and pharmaceuticals sectors.
Mr. Qatari has over 17 years of experience in R&D, quality assurance, and regulatory compliance, while Mr. Maurya has 12 years of experience with multinational companies, specializing in regulatory affairs and quality assurance. They will provide insights into the current state of medical device regulations in India.
Currently, the Central Drugs Standard Control Organization (CDSCO) oversees medical device regulations, classifying devices as either notified (regulated) or non-notified (non-regulated). High-risk devices, such as stents and heart valves, require import licenses and compliance documentation, whereas low-risk devices do not.
Upcoming regulatory changes will replace the current classification system with a class-based system aligned with global standards, requiring import licenses for all classes. Notably, clinical trials will not be needed for Class A and B devices, but may be required for Class C and D devices depending on the country of origin.
The new regulations, still in draft form, are expected to see implementation soon, with ongoing discussions among stakeholders. Device manufacturers are advised to ensure compliance with ISO 13485 standards and maintain strong communication with Indian partners to navigate the regulatory landscape effectively.
The session concludes with a Q&A to address specific attendee questions.