Market Approval for Medical Devices:
New Law Now in Force in Japan

New regulations apply for medical devices manufacturers that distribute products in Japan. The "New Japanese Pharmaceutical Affairs Law (PAL)" that came into force on April 1, 2005 heralds both a change in market approval requirements and harmonizes with the international regulatory system of medical devices and IVD reagents. TÜV Japan Ltd. is a Registered Certification Body (RCB) - and can conduct medical device certification in compliance with the new legal regulations. TÜV America now offers clients PAL assessment services through TÜV 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 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 Japan Ltd. can conduct the certification for all applicable products.

Local Marketing Business Unit Compulsory
All classes of medical devices are subject to one condition: A license or registration of the manufacturing facilities involved must be proven in order for a medical device to be distributed on the Japanese market. In the case of production units abroad, this is restricted to a registration. Above all, the Marketing Authorization Holder must have a valid license. In order to retain this, a marketing manager, a QM supervisor and a local safety supervisor in Japan are required in addition to the effective installation of a quality management system. The quality system requirements applicable to manufacturing facilities are the Good Manufacturing Practice (GMP), which substantially equals the requirements of the ISO 13485:2003. Requirements that apply to Marketing Authorization Holders are Good Quality Control Practice (GQP) and Good Vigilance Practice (GVP).

"Essential Principle Checklist" requirements to be fulfilled
Which documents now need to be prepared for a product approval? In both cases an official application has to be submitted describing the medical device or in-vitro-diagnostic in detail. In the case of a certification, the Third Party needs to prove that the respective product requirements as stated in the "essential principle checklist" have been met via documentation, such as the Summary Technical Documentation (STED). TÜV Japan, Ltd. accepts the STED both in the English or the Japanese language.

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.

No standardized transition period
The new version of the PAL marks a significant change in many respects to the Japanese medical device market. Which transition period applies for the new rules? According to the Japanese system, Japanese Manufacturing Facilities and Marketing Authorization Holders (former In-Country Care Takers) need to renew existing licenses every five years. The marketing business unit has to be set-up by the time the next renewal of business licenses comes up and the testing for class II products has to be replaced by a certification of a Third Party at this time.

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.