The Asian Harmonization Working Party (AHWP), an organisation that was constituted to forge a common direction for the harmonization of medical devices regulation in Asia and to facilitate a linkage with the Global Harmonization Task Force (GHTF), will hold its next meeting on November 5 and 6 in New Delhi. This is for the first time that AHWP meeting is being held in India.
The meeting could not have come at a more opportune time, as the government of India is presently framing a new regulatory mechanism for the medical devices industry in the country with an aim to bring the best quality medical devices to the people. There is a concerted effort to evolve regulations harmonized with the GHTF while balancing the special needs of the emerging Indian medical devices industry. The meeting is being held with the support and participation of Union health and family welfare ministry.
Apart from regulatory officials from Asian countries, US FDA officials are also expected to be present in the meeting. Representatives from government, regulatory authorities from AHWP Member Economies, professionals from the medical devices industry and other experts are also expected to participate in the meeting.
Senior Union health ministry officials including DCGI Dr Surinder Singh, secretary in the ministry of health Naresh Dayal and Director General of Health Services Dr R K Srivastava are expected to speak in the first session of the meeting which will be inaugurated by Union health minister Dr Anbumani Ramadoss.
The Indian medical devices industry is so far an unregulated sector in the country. Indian medical device market estimated to be the fourth largest market in Asia at $2.12 billion is growing at a rate of 15-17 per cent per year towards $5 billion by 2012.
The meeting will provide a forum for discussion and training, facilitate information exchange and initiates projects relating to GHTF harmonization among regulators and industry groups in Asia.
A pre-meeting workshop will be held on November 3 and 4 in conjunction with the 13th AHWP meeting. The pre-meeting workshop provides a platform for education and information sharing and exchange and is open for participation of representatives from the government, regulatory bodies and the industry from the Asian region. The workshop will deliberate on Topics like device classifications, ISO 13485, conformity assessment, post-market surveillance, risk management, in-vitro diagnostic devices, GMDN/UMDN and clinical evaluation.