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Market Approval for Medical Devices: Japanese Pharmaceutical Affairs Law
Established on April 1, 2005, the "Japanese Pharmaceutical Affairs Law (PAL)" regulates medical devices distributed in Japan. It heralds both a change in market approval requirements and harmonizes with the international regulatory system of medical devices and IVD reagents. TÜV SÜD Japan Ltd. is a Registered Certification Body (RCB) - and can conduct medical device certification in compliance with the new legal regulations. TÜV SÜD America now offers clients PAL assessment services through TÜV SÜD Japan Ltd.
The amended law regulates Medical Devices, IVD reagents, medicines, toiletry products and cosmetics. Based on the Global Medical Device Nomenclature (GMDN) system, medical devices are now divided into four classes. Class I includes lower risk devices (1195) that do not require involvement of an independent party in order to enter the Japanese market. Class 2 includes medium risk products (1785) for which a certification through a "Third Party" such as TÜV SÜD Japan Ltd. is necessary. Class 3 and 4 devices (1064) need to be approved by the Minister of Health, Labor and Welfare (MHLW) after evaluation by the Pharmaceuticals and Medical Devices Agency (PMDA).
The marketing certification system for class 2 devices is applicable to approximately 820 medical devices and 370 IVD reagents. For further products, marketing certification may become possible once conformity assessment criteria have been released by MHLW. Within the realm of its status of Registered Certification Body according to PAL, TÜV SÜD Japan Ltd. can conduct the certification for all applicable products.
Business Unit Compulsory
Principle Checklist" requirements to be fulfilled
With both of these procedures, not only is the product considered, but also the "Good Manufacturing Practice" of the respective manufacturing facilities. The Japanese GMP criteria can be proven through documentation or within the framework of an audit.
Foreign manufacturers who want to distribute their product in Japan are bound to the new rules and regulations beginning April 1, 2005.
For more information, contact us.