Medical Device in Japan

In Japan, Medical devices and in vitro diagnostic products are regulated by the Ministry of Health Labor and Welfare (MHLW) under the Japan Pharmaceutical & Medical Device Act (PMD Act).

 

While the Japanese market is lucrative providing good opportunities for medical device and in vitro diagnostic products, it is also challenging due to the complexity of the regulations.

 

It is absolutely important to determine the proper classification and

applicable regulatory requirements to which your device or IVD must adhere, and it is the first step to the successful move in Japan.

 

Key Requirements to consider in Japan

 

• Device classification and grouping

• Japan Medical Device Nomenclature (JMDN) code with predicate devices

• Confirmation or Identification of Potential Predicate Devices

• Applicable registration route or pathway

(1) New / Improved / Generic, depending on the device novelty

(2) Pre-market Submission; Pre-market Certification; Pre-market Approval

• Applicable test requirements

• Quality System and Foreign Manufacturer Registration requirements



Please contact us at info@asia-register.com with your inquiries and brief explanation of your product.