Most devices fall under Class II, with a small number classified as Class III. Certification is issued by Registered Certification Bodies approved by the Ministry of Health, Labour and Welfare. The following are some of the more representative organizations.
Official Website of Japan's PMD Act：https://www.japaneselawtranslation.go.jp/ja/laws/view/3214
Most of them are authorized for Class II medical devices under technical standards, while a small number cover Class III devices. Certifications are issued by Registered Certification Bodies (RCBs) approved by the Ministry of Health, Labour and Welfare (MHLW). Below are representative institutions of this type.
Japanese.
1. Class I Medical Device Notification Process
Preparation of product notification application materials
Submission of application to the PMDA
PMDA acceptance and stamping
2. Class II/Class III Medical Device Certification Process
(1) Product Approval
Preparation of Application Materials (Requires preparation of Annexes 1–7 and various supplementary documents, including intended use, design principles, raw materials, performance and safety, instructions for use, and accompanying documents)
Submission of Application Materials
Corrective Actions Based on Instructions from the Certification Authority
Completion of Approval
(2) QMS (Quality Management System) Audit
Submission of Audit Documentation (Including ISO 13485 certification, annual audit reports, and the QMS manual)
Documentary Review (if ISO 13485 certification is held)
QMS Audit of the Chinese Manufacturer and the Importing Company (QMS review is also required for Japanese warehouses)
Revision of the QMS Manual and Records
Documentary Review or On-site Audit
Implementation of corrective actions based on the certification body’s instructions
Completion of Approval (based on PMDA’s comprehensive assessment)
3. Approval Process for Class 2/Class 3 Devices Without Reference Standards and Class 4 Medical Devices
Preliminary Communication: Various meetings with PMDA to determine the application category, the need for clinical trials, and the availability of relevant reports; competitive product comparisons may be conducted; if clinical trials are required, they will be conducted (some steps may be omitted).
Product Approval: Preparation of application materials → Submission of application materials → Correction of issues raised by PMDA → Completion of approval.
QMS Audit: Process as described above for QMS review
A: Medical device registration does not expire, but registrants are required to renew their QMS certificate every 5 years, and registrants are required to initiate the renewal process six months in advance.
A: Class I product is not required; Class II and above level need, the basic requirements are the same as ISO 13485. In addition to directly providing ISO 13485 certificate and annual audit report, but also need to accept the Japanese regulatory authorities QMS system document audit.
A: It is acceptable to cooperate with Japanese import agents and entrust agents to help complete the procedures of product certification. Wiselink JP Co., Ltd. can serve as the Japanese DMAH of Chinese manufacturers to help Chinese manufacturers complete foreign manufacturer login, product compliance registration and customs clearance import services.
A: Agreed. Japan is one of the five MDSAP countries (Australia, the United States, Canada, Brazil, Japan).
A: Medical devices in Japan are divided into general devices, specific conservative devices, benchmarking, non-benchmarking devices and other categories. If you want to confirm the registration approach of devices in Japan, you can contact the business manager of Wiselink for inquiry.
