Regulatory Requirements concerning Quality Assurance of Medical Devices in Japan

Japan is an interesting market, also for medical devices. But in some parts the country is very different from Europe with regard to culture (writing, requirements concerning the appearance of packaging etc.). Insofar, it is interesting to know which requirements concerning medical devices are imposed by the authorities in Japan. There exists a translation of the relevant Japanese regulation in the English language as concerns the regulatory requirements on the quality assurance of medical devices. The Japanese Ministry of Health, Labour and Welfare issued a Ministerial Ordinance under the number 136 in 2004 which also is available in English.

Apart from general provisions the document also describes the standards concerning the topic quality assurance for medicinal products, quasi medicinal products and cosmetics. The requirements on the quality assurance for medical devices are addressed separately. The Ordinance is supplemented by annexes (such as a flow chart on the handling of deviations).

In the chapter on the general provisions (chapter 1) article 1 explains the purpose of the document. Article 2 determines definitions. Chapter 4 addresses the standards for quality assurance of medical devices in 5 articles (articles 21 - 25). The articles regulate the following:

• Article 21: Handling of notifications concerning repair 
• Article 22: Requirements imposed on distributors concerning quality assurance  
• Article 23: Handling of notifications concerning distribution 
• Article 24: Control of documents and reports concerning medical devices 
• Article 25: Reference to provisions on medicinal products (provisions to be applied mutatis mutandis)

In article 25 reference is also made to the tasks of the head of quality assurance and to the duration of archiving periods comparable to those laid down in the provisions on medicinal products.

Conclusions: The provisions concerning medical devices in the Ministerial Ordinance No 136 of the Japanese Ministry of Health, Labour and Welfare are relatively short and essentially closely related to the provisions on medicinal products.

You will find further details in the Ministerial Ordinance.

Postscript: If you are interested in what the future regulations for medical devices in Europe could look like we recommend participating in the ECA Webinar "The new EU Regulations for Medical Devices - What could happen? taking place on 20 February 2013.