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Planning to Enter the Medical Device Field in Japan? Get Familiar With the PMD Act

Posted by TUV Rheinland on Oct 11, 2018 3:33:28 PM
TUV Rheinland


In November 2014, Japan enacted the Pharmaceutical and Medical Device Act, or PMD Act.

Officially called “The Act on Securing the Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics”, the new law by the Ministry of Health, Labour and Welfare (MHLW) followed a thorough review and marked a substantial revision of the old Pharmaceutical Affairs Law (PAL).


Why Is There a Need for the New Act?

The medical device industry is expected to lead the Japanese economy in the future. About 90 percent of the 20 leading manufacturers of home electronics appliances in Japan have already diversified into the medical device field or have a plan for the development of medical devices, while 70 percent of the 99 leading chemical product manufacturers have already advanced into the medical device field or plan to develop medical devices in the future.

The PMD Act acts as a market barrier that makes it more difficult for manufacturers from different industries to enter the medical device field. Of particular note, when revising the PAL in 2013 to create the PMD Act, the government shifted the focus of regulations to design control (the “design and development process”), to allow the PMD Act to keep pace with its counterparts in the U.S. and Europe.


5 Important Differences Between the Old PAL and the New PMD Act

  1. Application of design control
  2. Revision of Essential Requirements and their application to software
  3. Treating stand-alone programs as medical devices
  4. Change in the framework of QMS Conformity Inspection
  5. Streamlining the QMS Conformity Inspection


The main purpose of the PMD Act is to help Japanese MAHs plan and complete their products based on the same rules as American and European manufacturers – in terms of quality, efficacy, safety, cost and the distribution of medical devices – so they can meet global standard regulations right out of the starting gate. It will also make it more likely that Japanese MAHs will achieve global competitiveness and be able to advance into overseas markets successfully.


This article first appeared on JapanIndustryNews.com. Click here to read the full article.


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Topics: compliance, Japan, medical devices