MedTech stakeholders discuss regulatory harmonization at 22nd AHWP conference

New Delhi: The 22nd conference of Asian Harmonization Working Party (AHWP) is currently being conducted by Central Drugs Standard Control Organization (CDSCO) and National Drug Regulatory Authority (NDRA) of India in collaboration with Ministry of Health and Family Welfare at New Delhi.

The key objective of the five-day event recently inaugurated by Ms Anupriya Patel, MoS (Health and Family Welfare) is to develop and recommend approaches for the convergence and harmonization of medical device regulations in Asia and beyond and to facilitate the exchange of knowledge and expertise amongst regulators and the industry.

Asian Harmonization Working Party (AHWP) was established in 1999 as a voluntary non-profit organization of the 30 national regulators of member countries and industry members with a goal to promote regulatory harmonization on medical device regulations in Asia and other regions in accordance with the guidance issued by International Medical Device Regulators Forums (IMDRF). The AHWP works in collaboration with related international organizations such as IMDRF, WHO, International Organization for Standardization (ISO), etc.

The Government has effected an ecosystem to promote Make In India, R&D, and innovation in medical device sector in the country. Moreover, the Health Ministry has also come out with the recent regulation i.e. Medical Devices Rules, 2017, for the better harmonization with global regulatory practices and to have transparent, predictable and robust regulatory system which will further ensure safety, quality and performance of medical devices and In vitro diagnostics being manufactured in the country. Additionally, the Government has already allowed 100% FDI in the medical devices sector to promote Make in India. With these combined efforts for Make in India and with a strong regulatory framework, the government has strived to create the ecosystem which caters to all stakeholders.

The Government intends that with such efforts, affordable medical devices to the best of the quality standards is made available to the citizens across the vast and diverse geographical locations.

The inaugural function was also attended by Mrs Preeti Sudan, Secretary (HFW), Dr R K Vats, Additional Secretary (Health) along with the other senior officers of the Ministry, CDSCO, NDRA, dignitaries from other countries and representatives of the development partners.