Nov 10, 2014

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 Act (PMD Act) 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 PMD Act 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 PMD Act 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:

  • The device or product name to be registered
  • Product group
  • Manufacturing facility

Certificates of QMS Conformance are valid for five years, and facilities listed on these certificates do not have to undergo additional assessments in cases where they produce additional devices in the same product groups listed on those certificates.

New registration pathways for manufacturers

The PMD Act does away with PAL requirements that domestic device manufacturers obtain manufacturer licenses and that foreign manufacturers obtain foreign manufacturer accreditations. Instead, domestic manufacturers must now register their manufacturing facilities with their local prefectural authorities; foreign companies, on the other hand, must register their facilities with the Pharmaceutical and Medical Devices Agency’s (PMDA) main office.

Expanded third party certification options

Under the PAL, registrants could opt to undergo third-party certification from Registered Certification Bodies (RCBs) instead of standard PMDA reviews only if their devices were classified as Specified Controlled and qualified for premarket certification.

Now, the PMD Act will allow more Class II as well as some Class III devices to qualify for third-party certification, which could lead to less complex market pathways for some foreign manufacturers.

Less challenging market access in Japan?

Japan’s medical device market authorization process has been considered one of the most challenging and rigorous in the world. Although implementation of the PMD Act won’t necessarily make Japanese registration easy, it should at least make the process less challenging and more transparent.

For a full analysis of the PMD Act and its effects on the Japanese medical device registration process, please see Emergo’s whitepaper on Japanese medical device regulatory reforms.


  • Stewart Eisenhart