Dec 2, 2010

As you may know, medical devices in Japan are classified as follows:

  • Class 1 (General)
  • Class 2 (Designated/Specified Controlled)
  • Class 2 (Non-Designated Controlled)
  • Class 3 (Highly Controlled)
  • Class 4 (Highly Controlled)

The list of devices that fall under the scope of Class 2 has recently been modified. On 27 September 2010, the Ministry of Health Labor and Welfare (MHLW) released Ministerial Ordinance No. 354, which announced additional pre-market certificate standards for 120 Class 2 medical devices. Essentially this means that 120 medical devices now considered Specified Controlled Devices and can be registered with the MHLW though the pre-market certification process (third party certification). To explain further, of the 1788 Class 2 medical devices in Japan, about 58% (916 plus the additional 120), are now Specified Controlled Devices and these devices are subject to the pre-market certification process. Click to download a graphic representation of the Japanese approval process.

It is our understanding that the MHLW is planning to issue pre-market certification standards for ALL Class 2 devices in 2011, but this information has only been disclosed verbally by the MHLW official at the Japan Federation of Medical Device Association Seminar (September 27th, 2010).

As another brief regulatory update, in late July 2010 the PMDA issued a draft proposal which, if adopted, would start a pilot program for a pre-review system of application documents for devices subject to Pre-Market Approval with clinical data.

Presently, the timeline to complete a clinical trial is lengthy, and subsequently, a device lag occurs. Under the pilot, the applicant could submit the application documents without clinical data, and the PMDA would then review the submitted materials in advance. The clinical data would be supplied when the clinical trial is concluded. In effect, this would be a “pre-consultation” system in order to expedite the review process.

The proposed implementation is 1 October 2010, and though we have not heard more about its issuance, our colleagues in our Tokyo office continue to monitor the topic and we inform you as we learn more.


  • Stewart Eisenhart