Chapter 1 Japanese Medical Device Administration

1. Japanese MHLW / PMDA

Ministry of health，labor and welfare (MHLW) is responsible for the quality and safety of medical device, and to promote the formulation and implementation of relevant policies and regulations. The majority of the responsibilities include:

①Formulate medical device regulatory policies

② Final audit of registration approval

③ Product delisting

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is the body responsible for product audit and regulation of the marketing of medical devices. It is a relatively independent administrative agency that works with WHLW to ensure the safety and quality of medical devices. PMDA assists in the implementation of WHLW medical device regulatory policies, and its responsibilities include:

① Audit and approval of medical devices

② QMS/GLP/GCP inspection

③ Collection and analysis of adverse event reports

2. Administrative Regulation

Pharmaceutical and Medical Device Act，Abbreviation PMD act.

https://www.japaneselawtranslation.go.jp/ja/laws/view/3214

3. Risk Level Classification

Japanese medical devices are divided into four risk levels: I, II, III and IV

4. Applicant/Certificate Holder

5. Registration Language

Japanese.

Chapter 2 Registration Flow

1. Registration Flow

2. Medical device registration approach

3. Label | Packaging requirements

Article 63 of the PMD Act specifies the information required to be stated on the direct container or package of a medical device:

① The name and address of the marketing authorization holder

② Name

③ Manufacturing number or manufacturing code

④ For the medical devices specified by MHIW, the weight, volume, quantity, etc., of the contents

⑤Where standards for medical devices are prescribed in accordance with the provisions of Articles 41 (3) and 42 (2), the matters specified in these standards shall be printed on the direct container or direct package

⑥ Validity period of medical device specified by MHLW

Chapter 3 FAQ

Q: What issues should be paid attention to after the approval of medical devices?

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.

Q: Does it require a QMS certificate for medical device registration in Japan?

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.

Q: How to register medical devices without a company in Japan?

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.

Q: The manufacturer does not have ISO13485 system certificate, is it acceptable to use MDSAP certificate?

A: Agreed. Japan is one of the five MDSAP countries (Australia, the United States, Canada, Brazil, Japan).

Q: How to determine whether a medical device is a specific conservative device in 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.

Chapter 4 Certificate Template