In Japan, the Ministry of Health, Labor and Welfare (MHLW) regulates the manufacture, sale, and distribution of medical devices. The current law is the Pharmaceutical and Medical Devices Act (PMD Act), revised in November 2014 and replacing the former Japanese Pharmaceutical Affairs Act (JPAL).

Medical device approval (certification) in Japan will take the next step.

Applicant:

1. Companies with a manufacturing and marketing license for medical devices in Japan (MAH: Marketing Authorization Holder) can be an applicant.

2. Foreign manufacturers designate companies with a manufacturing and marketing license for medical devices in Japan (MAH) as a dedicated marketing authorization holder (D-MAH: Designated-Marketing Authorization Holder), and D-MAH becomes an applicant

MAH holds product liability for the product under the PMD-Act. As a company located overseas has product liability, D-MAH can be changed through a simple procedure.

Step 0:

Search for the generic name (which is determined by JMDN [Japan Medical Device Nomenclature]) of the medical device you wish to apply for, and review the application method and technical issues based on their approval (certification) criteria and the status of prior devices in Japan.

(If it corresponds to a device that is de novo (completely new) in Japan, it is necessary to consult with the PMDA before submitting the application).

Step 1: Select an applicant (MAH or D-MAH) and prepare the application.

Please note that all application and technical documents must be prepared in Japanese.

To prepare the application, the manufacturing plant (Design, assembly, and sterilization) must be registered under the PMD Act (Manufacturing plants in Japan must be registered by the prefecture, and overseas manufacturers must apply for registration with the PMDA.). Each plant will be prepared to comply with the QMS Ministerial Order in compliance with ISO 13485: 2016 (with some additional requirements).

Step 2: Apply for medical device certification

Applications will be submitted to an RCB (Recognized Certification Body) or PMDA based on the Class determined by the generic name of the device.

Class I is only submitted to the PMDA.

Class II and Class III with certification criteria are submitted to an RCB.

Class III and Class IV pre-marketing approval applications and registration materials are submitted to the PMDA in STED format for review.

Step 3: QMS Conformity Assessment

Class I has a QMS Conformity Assessment upon application.

Class II and Class III medical devices with certification standards undergo a QMS assessment by an RCB. This process can be replaced by obtaining an MDSAP or ISO 13485 certification that meets certain conditions, but MAH and D-MAH are required to conduct on-site audits or submit QMS compliance inspection reports issued during a certain period of time.

Class III and Class IV are subject to QMS review by PMDA.

In general, on-site audits are required for "new" devices that do not have existing JMDN codes, Class IV devices, and devices that require clinical investigation.

Step 4: QMS Certificate of Conformity

All classes require a QMS Certificate of Conformity issued by PMDA or an RCB.

Step 5: Certificate

For Class II, after the technical documentation of the medical device, a certificate is issued for each product by an RCB. For Class III and Class IV, an approval certificate is issued by the MHLW via PMDA.

Step 6:

Certificates issued by an RCB for each medical device (Class II and some Class III) and approval certificates issued by the PMDA do not have an expiration date.

However, the QMS must be maintained during annual audits.

DQS Japan, one of the DQS Group, has been accredited as an RCB by the MHLW of Japan since the enactment of the former JPAL in 2004 and is able to provide Class II and some Class III certification. In addition, DQS Medizinprodukte, as the Auditing Organization (AO) of MDSAP, is able to register for review of MDSAP, which is a QMS review of regulatory approvals common to the 5 countries of Japan, the United States, Canada, Australia, and Brazil.

 

The DQS Group is able to assist new medical device manufacturers entering the Japanese market while sharing roles.

Author
Hiroaki Kanki

Career:Researcher: Brain Science Institute (BSI), Institute for Physical and Chemical Research (RIKEN)Project Instructor: Physiology Department, Keio University Medical SchoolResearcher: Lifescience Institute, Saga-Prefectural Medical CentreRegulatory Affairs Manager (RAM): DQS Japan MDR/MDSAP Business Unit

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