Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
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.
With the help of your MAH, classify your product to determine the next action:
|Class I - General Medical Device||Approval 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 Device||Minister's approval needed for marketing authorization|
|Class III or IV - Highly Controlled Medical Device||Minister's approval needed for marketing authorization|
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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