Asian Harmonization Working Party

The group, comprised of 15 experts from industry, academia, and government, seeks to formulate recommendations on how Japan could improve access to pharmaceuticals and medical devices in Asia. During the first year, the task force held a series of discussions on a grand design for regulatory harmonization and relevant matters, which it then submitted to the Executive Committee. Japan has committed to promoting universal health coverage UHC as part of its contribution to the global health field. In other Asian countries, however, the access to pharmaceuticals and medical devices—including products that utilize innovative technologies—is insufficient, posing a serious issue to that objective.

The objective of the study is to expose the achievements of advance application of textile material. Previously textiles are only used as normally wound care products, diapers, braces, prostheses and outhouses, wipes, breathing masks, bedding and covers, ropes and belts etc but the technology has been upgraded. Textile materials and products that have been engineered to meet particular needs are suitable for many applications as well as medical and surgical application in which a combination of strength, flexibility, and sometimes moisture- and air-permeability is required. Materials used include monofilament and multifilament yarns, woven, knitted, and nonwoven fabrics, and composite structures. The applications are many and diverse, ranging from a single-thread suture to the complex composite structures used for bone replacement, and from the simple cleaning wipe to the advanced barrier fabrics used in operating rooms.

The key objective of the event was 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 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. Moreover, the Health Ministry has also come out with the recent regulation i. Medical Devices Rules, , for 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.

Gain practical advice on how regulations are being applied to enable you to take full advantage of this rapidly growing market. Now that the European medical device market is well established, the next growth area is Asia-Pacific. China, together with other countries in this region, have all implemented, or are in the process of implementing, their own medical device regulations.