Regulation of Medical Devices
There are two regulatory authorities responsible for regulation of medical devices in Japan: the Ministry of Health, Labour and Welfare (MHLW) and the PMDA. The MHLW is responsible for the administrative actions, e.g, guidance or decision of product approval pursuant to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter, PMD Act) and judgment on whether or not the product is considered as medical devices. On the other hand, the PMDA undertakes product review and post-market safety measures.
- PMD Act (Link for The Japanese Law Translation Database System (website managed by the Ministry of Justice that provides translations of Japanese laws and regulations))
Classification of Medical Devices
In Japan, medical devices are classified into four classes based on the risk level; Class I (Extremely low risk), Class II (low risk), Class III (medium risk) and Class IV (high risk). In order to market medical devices in Japan, a foreign manufacturer has to obtain approval/certification or submit notification, depending on the classification, pursuant to PMD Act, through a Japanese Marketing Authorization Holder (MAH) or a Japanese manufacturer appointed by such foreign manufacturer. Required procedures for each device classification are shown below.
Class I devices:
Notification to the PMDA
Class II devices
- for those certification standards exist:
Certification by registered certification body
- other Class II devices:
Approval of the MHLW
Class III devices
- for those certification standards exist:
Certification by registered certification body
- other Class III devices:
Approval of the MHLW
Class IV devices:
Approval of the MHLW
Regardless of the Class of the medical device, the MAH of such device must ensure efficacy, safety and quality thereof based on the evidence before submission.
- For Medical Devices that are required to be Certified
For devices that require “Certification by registered certification body”, the product must be certified by a registered certification body.
List of Registered Certification Bodies (available only in Japanese):
- For Medical Devices that are required to be Approved
Medical devices that require “Approval of the MHLW” have to be evaluated for safety and efficacy by the PMDA (i.e, product review). Regulatory requirements for individual products to be approved are assessed on a case-by-case basis and answered in the PMDA's face-to-face consultation meetings (fees applicable).
Please refer to “Consultations” page for details of the PMDA's face-to-face consultation meetings.
Other Information
Scope of approval/certification of medical devices and basic rules of evaluation criteria for medical devices are provided in “Medical devices” page (available only in Japanese).
Specific criteria for each product category are available from the following link. Pease note that amount of available information may differ between Japanese and English.
Medical Device Standards Related Information (Japanese)
Criteria for Medical Devices (English)
In addition, regulatory information (e.g, Ministerial Ordinances, Regulatory Notifications, etc) is provided “Regulatory Information” page.