Perspectives of harmonisation of medical device regulation and ways to bring about convergence of regulatory systems across countries will be discussed threadbare at the upcoming 13th Asian Harmonisation Working Party (AHWP) meeting in New Delhi on November 5 and 6.
The AHWP meeting will be preceded by two days of pre-meeting workshops on November 3 and 4. The topics have been selected to address the needs of the Indian industry and regulators, as well as those of other member economies. The two-day meeting is being jointly organized by FICCI and AHWP, with the support and participation of the Union Ministry of Health and Family Welfare.
The proposed pre-meeting workshop topics include GHTF device classification, ISO 13485, conformity assessment, post market surveillance, in-vitro diagnostic devices, risk management and clinical evidence. The organization of the 13th Asian harmonization Working Party (AHWP) meeting is a significant step reflecting the Government and the industry commitment to global harmonisation of medical device regulatory standards in line with international best practice, said a release by FICCI.
With medical device manufacturing becoming a globalised business, the need for convergence of medical device regulatory systems has increased. The Indian industry is largely unaware of the AHWP and the importance of harmonization. The upcoming meeting offers an opportunity for 4 days of intense interaction with regulators and industry professionals from more than 10 countries, it said.
An India-focused session is being planned on the sidelines of the AHWP meeting with leaders from various sectors talking about the India vision. FICCI is working very closely with the office of the DCGI to make this meeting pertinent to the Indian environment.