Quality Management Systems (QMS) Compliance Audits for Medical Devices in Japan

In Japan, medical device applicants for product registration must demonstrate QMS compliance. A QMS audit may be on-site or paper. For higher risk medical products, the PMDA is more likely to visit the foreign facilities in person. Japanese QMS standards are closely based on ISO 13485 standards, but have a few distinct differences. Ministerial Ordinance 169 is the main regulation specifically listing QMS requirements.

Physical audits for QMS compliance for the foreign factory are required for Class III and IV medical devices and sometimes Class II devices. QMS audits also cover other facilities besides manufacturing facilities, such as the contract sterilization facility, contract testing facility and contract design facility.

To help medical device companies with QMS audits, PBM can do a "mock audit" prior to the PMDA visit.

For more information on Japanese medical device quality standards, please see the following PBM publications and/or contact us to discuss your specific needs.

More on Japan

Get Sourcing/Manufacturing in Asia Consulting

Back to top