Japan Changing Foreign Manufacturer Accreditation and QMS Inspection Systems

Regulations in Japan are rapidly changing and the information in this news brief from 2013 may provide outdated information on Japan’s current medical device industry. For updated and in-depth information on Japan’s medical device regulations and registration process, please visit our Japan Medical Device Registration page.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will soon alter the way it accredits foreign manufacturers and conducts quality management system (QMS) inspections. Under the country’s newly revised Pharmaceutical Affairs Law (PAL), these systems will require fewer total inspections and less documentation up front, according to a PMDA spokesperson.

Currently, foreign medical device manufacturers are required to receive PMDA accreditation before they are allowed to register and market their products in Japan. In order to receive accreditation, they must submit documentation about their personnel and manufacturing facilities for PMDA approval. Under the new system, foreign medical device manufacturers will no longer have to submit manufacturing facility information. Instead, they will need to submit only personnel information, such as organizational flowcharts. If the PMDA requires an on-site FMA inspection (which is rare), only then will foreign medical device manufacturers need to submit manufacturing facility information like floor plans and production process flowcharts. If approved by the PMDA, foreign medical device and IVD manufacturers will no longer be accredited, but they will simply be registered.

QMS inspections will also undergo major changes under the revised PAL. Currently, either the PMDA or a third party must inspect each medical device before it goes on the Japanese market. According to the PAL revisions, future QMS inspections will take place according to the product family, rather than the individual product. For example, a manufacturer that produces three products in the same product family would have to undergo only one QMS inspection for all three medical devices. Regulators have not yet devised a final list of product families, but factors taken into account for grouping will include the usage method, the manufacturing process and the risk of the device.

Regulators expect the new PAL — which is still under revision — to go into effect in late 2014.