Legal reforms affecting medical device regulation in Japan have passed the country’s Diet and are now published in the official Japanese gazette, bringing them closer to full enactment in Asia’s largest single medical device market.
The Pharmaceutical Affairs Law (PAL) Reform Act (links to document in Japanese), introduced in mid 2013, will have the following broad effects on medical device manufacturers in Japan:
- Stronger safety measures for devices and medical equipment
- Establishing regulations based on device characteristics
- Regulation for regenerative medical devices and equipment
PAL reforms specifically geared toward Japan's medical device market include establishing a Marketing Authorization Holder (MAH) authorized representation chapter for medical devices separate from MAH requirements for drugs, and expands Japan’s third-party review system (Ninsho) to cover some devices classified as Highly Controlled.
In addition, regulatory reforms would require standalone software used for diagnostic purposes to undergo pre-market submission (Todokede), pre-market certification (Ninsho) or pre-market approval (Shonin) depending on product risk characteristics. Quality management system conformity assessments will also undergo rationalization under the PAL Reform Act.
Long-term impacts of regulatory reforms on medical device registration and approval in Japan are not yet apparent; guidance on PAL Reform Act enforcement processes are expected in 2014. Emergo Group consultants in Tokyo will provide further details in the coming months.