The PMD Act requires foreign manufacturers to apply to PMDA for registration of their manufacturing plants and obtain a foreign manufacturer registration (FMR) certificate. The FMR certificate is a requirement when submitting an application for medical device registration, and a certificate must be obtained before the application.
Japanese marketing authorization holder (? MAH) system stipulates that only after obtaining the MAH permission of a certain type of product can a specific product be put on the market.
And a class of medical devices (an application for pre-marketing registration must be submitted to PMDA. The application is a notification document, and PMDA does not make any audit opinions.
Registration process:? 1. Determine the product category
According to PMD Act and Japanese Medical Equipment Nomenclature (JMDN) code, the equipment classification is determined.
? 2. Authorized agent
A kind of equipment, designated as MAH in Japan. For other types of equipment, designate MAH or D-MAH to manage Japanese equipment registration.
? 3. Manufacturer registration
Japanese manufacturers submit applications for manufacturer registration (MR) to local authorities. Foreign manufacturers submit applications for foreign manufacturer registration (FMR) to PMDA.
? 4. Quality management system
The implementation of quality management system (QMS) needs to comply with PMD Act and MHLW regulations169. Class I equipment does not need QMS audit. The quality management system of secondary equipment shall be audited by a registered certification body (RCB). Class II (except special control), Class III and Class IV instruments shall be audited by the quality management system of PMDA. New devices without JMDN code, four types of devices or devices requiring clinical trials are usually reviewed by QMS on site. The quality management system certificate is valid for five years and will be updated six months before its expiration.
? 5. Submit an application for listing
Class I devices shall submit pre-marketing notice to PMDA. Class II devices shall submit an application for pre-marketing certification to the RCB. Category II (except special control), Category III and Category IV devices shall submit the pre-marketing approval application and registration documents in STED (technical document summary) format to PMDA. All submitted documents must be in Japanese.
6. Issue certificates
The second type of equipment is certified before listing by RCB. Category II (except special control), Category III and Category IV devices shall be issued with pre-marketing approval certificates by MHLW. Device registration has no validity period.
sell
Medical devices enter the Japanese market for sale.