The urgent need for setting quality standards for medical devices in India was stressed at a seminar on 'medical devices regulations - way forward' here on November 13. The speakers talked about international practices in medical devices regulation and called for a harmonized standard across the countries for medical devices. The event was organised by Indian Pharmacy Graduates Association (IPGA).
Speaking at the inaugural function, Dr M Venkataswarlu, Drugs Controller General (India) opined that licensing a medical device without setting a recognized standard for that device makes no sense. He narrated India's efforts to define standards for medical devices.
Expert speakers touched upon topics like 'medical devices - current regulatory scenario in the country', 'ISO 13485 - 2003 Quality Systems Requirement for Regulatory Purposes', 'GHTF recommendations for countries developing regulations', 'standards and manufacturing requirements for medical devices' and 'medical devices regulation in Asia Pacific'. The speakers were Carol Hunter (Lead Auditor, Intertek System Certification), Michael Gropp (Vice President, Abbot Vascular), Dr Sanjeev Gupta (Yashraj Biotechnology) and Dr M S Pillay (Deputy Director General, Ministry of Health, Malaysia).