3 Steps to Quality System Conformity Under the Japanese PAL

  1. If you're selling in to Japan for the first time, appoint a Market Authorization Holder (MAH) - a company located in Japan who will be responsible for selling your devices locally. Your MAH may be a distributor or another third party, or it may be your own company if you have an office in Japan.

    If you are already selling in Japan, confirm when your current authorizations expire. You will need to meet the new requirements of the PAL to renew these authorizations or obtain new ones.

  2. With the help of your MAH, classify your product to determine the next action:

    ClassRequirements
    Class I - General Medical DeviceApproval for marketing authorization not required
    Class II - Designated Controlled Medical Device (DCMD)Third-party certification required for both the product and your quality system
    Class II - Controlled Medical DeviceMinister's approval needed for marketing authorization
    Class III or IV - Highly Controlled Medical DeviceMinister's approval needed for marketing authorization
  3. Intertek can help you if your device is a Class II DCMD. We will perform the quality system audit with local auditors who are qualified by both Intertek and Nanotec Spindler. Your MAH will need to apply to Nanotec Spindler, a third-party certification body recognized by the MHLW (Japan's Ministry of Health, Labor, and Welfare) under the PAL.

    To help you meet product certification requirements, Intertek can also test your product to the CB Scheme and both the Japanese and IEC versions of the safety standard for the MHLW.

 
 

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