REGULATORY UPDATE: MHLW requires all class 2 medical devices to be reviewed by 3rd parties by the end of March 2012
On September 27, 2010, Japan MHLW issued the new Ministerial Ordinance (MO) No 354. This is the supplementary document of MO No. 112. According to the MHLW Action Plan to reduce device lag, all class 2 medical devices will be transferred to the 3rd party certification scheme by the end of March 2012.
Currently, there are 1,036 generally named class 2 devices that are designated to be handled by the 3rd party organizations. When MO No. 354 goes into effect, this number will include all 1,788 class 2 medical devices in Japan.
I asked our colleagues in UL Japan for help in locating the MO document in English. Unfortunately, the information is only available in Japanese at this time. However as a 3rd party under the Japan Pharmaceutical Affairs Law (PAL), the staff of UL Japan will be glad to help you to how to put your devices on Japanese market. The UL Japan staff are continuously participating the working group of this Action Plan and know the details of the type of devices and the applicable standards. Your local UL Account Executive can help connect you with our UL Japan experts. Click here to find the contact information for your local office.
For more information on UL's 3rd party services for market access to Japan, visit our webpage:
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