November 10, 2014 by Stewart Eisenhart
Revised medical device registration and approval requirements in Japan will become law November 25, 2014, and will impact several compliance areas for foreign manufactures active in the market, According to Emergo’s Tokyo office.
Replacing the Pharmaceutical Affairs Law (PAL), the Pharmaceutical and Medical Device Law (PMDL) will affect all major components of Japanese device registration, including in-country representation, quality management system compliance, third-party certifications and regulation of medical software.
New package insert rules
The PMDL contains more comprehensive requirements for device package insert information than previous Japanese regulations. Manufacturers of Class I, II, III and IV devices must use up-to-date medical literature as well as safety and vigilance data to prepare their package insert materials. Proposed package insert materials must also be included in registrants’ premarket applications.
Changes to Marketing Authorization Holder system
In order to qualify as a Marketing Authorization Holder (MAH) to provide authorized representation to foreign manufacturers in Japan, firms must now not only employ three qualified managers but also implement their own quality systems based on the Ministry of Health, Labour and Welfare’s Ordinance No. 169.
In most cases, the PMDL also subjects MAHs to quality system conformity assessments on a product rather than a facility basis. A Certificate of QMS Conformance is issued to the MAH, and now covers: