I. Introduction of PMDA

PMDA is known as Pharmaceuticals and Medical Devices Agency (PMDA), which is an independent administrative body under the jurisdiction of MHLW. PMDA's business includes review, safety countermeasures, health damage relief, etc., and technical review of medical devices and related research work.

II. Regulations

In Japan, laws and regulations governing pharmaceuticals and medical devices are categorized into three tiers:

Acts enacted by the Japanese Diet;

Cabinet Orders approved by the Cabinet;

Ministerial Ordinances issued by the Minister of Health, Labour and Welfare.

The core legal framework is the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (commonly abbreviated as the PMD Act).

Revised from the former Pharmaceutical Affairs Law, the regulatory system comprises the PMD Act, its Enforcement Order, the QMS Ministerial Ordinance, public notices, and administrative guidelines.

III. Classification

The Japanese Medical Device Nomenclature (JMDN) code specifies the path for classification and registration of medical devices. Medical devices are categorized into Class I, Class II, Class III and Class IV according to their risk level.

Class I are general medical devices, which are considered to be products with extremely low risk to humans even if an adverse event occurs, such as scalpels. → Subject to local government filing and no substantive review.

Class II are controlled medical devices that are considered to have a relatively low risk to humans even if an adverse event occurs, such as electronic endoscopes and catheters for digestive organs. → The third-party certification body, RCB, must be responsible for the review.

Class III is highly regulated medical devices that are considered to pose a relatively high risk to humans in the event of an adverse event. Examples include dialyzers, artificial bones, artificial respirators, and balloon catheters for cardiac vessels, etc. → PMDA review is required.

Class IV is highly regulated medical devices, which are products that are highly invasive to patients and have the potential to directly cause life-threatening injuries in the event of an adverse event, such as pacemakers, artificial hearts, and stents. → PMDA review is required

IV. PMDA certification information

1. Marketing Authorization Holder (MAH)/Designated Marketing Authorization Holder (D-MAH)

2. STED Summary (Registration Dossier) includes:

01 Product Specifications

02 Stability and Shelf-life Data

03 Performance Test Data

04 Risk Analysis

05 Clinical Data

06 Manufacturing (Process, Monitoring, Sterilization)

07 Compliance with Applicable Standards and Essential Principles

08 Development History (Previous Device Versions, Global Approvals)

3. Quality Management System (QMS) Audit

Conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) or a Registered Certification Body (RCB).

Required documents: Quality Manual, Procedural Documents, ISO 13485 Certificate, Organizational Chart, Manufacturing Flowcharts, Equipment List.

Scope: Covers facilities linked to the MAH, medical device design, and manufacturing.

On-site inspection necessity is determined by the certification body.

4. Multi-Regulatory Compliance

Foreign manufacturers must also comply with additional regulations (e.g., Electrical Appliances and Materials Safety Law [DEN-AN], Radio Wave Law [DENPA-HO]) for Japan market entry.

V. System Assessment

1. J-GMP audit is not required for Class I devices.

Class II devices are subject to J-GMP audit by the registered certification body (RCB).

Class II (except for special control), Class III and Class IV devices, QMS audit by PMDA.

2. New devices without a JMDN code, Class IV devices, or devices that require clinical trials are usually reviewed on-site.

J-GMP is a set of quality management system requirements based on ISO 13485 and additional special requirements of Japanese laws and regulations that must be met by medical device companies entering the Japanese market.

VI. PMDA medical device registration process

1. Determine the classification of medical device products

2. Appointment of MAH/D-MAH

All categories of devices: Appointment of MAH or D-MAH to manage the pre-market application or approval of devices in Japan.

MAH and D-MAH

Marketing Authorized Holder (MAH) can only file an application to market a specific product once he has received an MAH licence for a particular type of product. Since the foreign company does not have an office in Japan, it is necessary to appoint a Designated Marketing Authorization (D-MAH), who holds a business license in Japan, to coordinate the release of goods to the foreign company's distributors and to handle complaints and alert information matters.

3. Conducting manufacturer registration:

Japanese manufacturers submit Manufacturer Registration (MR) applications to local authorities.

Foreign manufacturers submit an application for Foreign Manufacturer Registration (FMR) to PMDA.

MR and FMR

Medical device products released into the Japanese market must comply with the Pharmaceutical and Medical Device Act (PMD Act).

○ The PMD Act requires Japanese manufacturers to apply for registration of their manufacturing sites with local organizations and obtain a Manufacturer registration (MR) certificate;

○ The PMD Act requires foreign manufacturers to apply to PMDA for registration of their manufacturing sites and obtain a Foreign manufacturer registration (FMR) certificate.

○ MR and FMR certificates are a requirement when submitting an application for registration of a medical device, and the certificates must be obtained before submitting the application.

4. Quality management system J-GMP

5. Submission of Marketing Application

(1) Pre-market registration application (Todokede)

Class I medical devices (A pre-market registration application must be submitted to PMDA. The application is a notification document, PMDA will not make any review comments.

(2) Pre-market certification (Ninsho)

Class II (and some Class III) devices with certified standards (Japanese Industrial Standards, JIS) must pass premarket certification. MAH should submit an application to the Registered Certification Body (RCB) and passes the certification.

(3) Pre-market approval (Shonin)

MAH or DMAH submits an application for pre-market approval to PMDA and obtains approval from the Ministry of Health, Labor and Welfare (MHLW) for Class II devices other than those under special control, and for Class III and IV devices.

6. Issuance of Certificates

Class II devices are issued a premarket approval certificate by the RCB.

Class II (except for special control), Class III and Class IV devices are issued a certificate of premarket approval by the MHLW.

There is no expiration date for device registration.

7. Entry and Sale of Medical Devices into the Japanese Market