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Medical Device Product Registration and Approval in Japan

 
MEDICAL DEVICE REGULATION IN JAPAN
 

Medical devices are regulated by the Pharmaceuticals and Medical Devices Agency from the Ministry of Health, Labour and Welfare (MHLW) whose objective is to improve the public health and safety of Japan by reviewing applications for marketing approval of medical devices, conducting safety measures, and providing relief to people who have suffered from adverse reactions. Medical devices are regulated under the Pharmaceuticals and Medical Devices Act.

 

Japan is one of the member countries in the current IMDRF (also the founder members of the previous GHTF). Japan has been involved in the drafting process of IMDRF/GHTF documents, in principle, the country also updates their regulation in alignment to IMDRF/GHTF harmonization initiatives actively. These include the 4 risk classification, essential principles, quality system as well as its audit.

 
MEDICAL DEVICE REGISTRATION AND APPROVAL IN JAPAN
 

Medical devices are classified in the table below (Class I being the lowest risk category while Class IV is the highest risk category):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Source of table: PMDA

 

 

Class I:

 

Only medical device notification to PMDA is needed 

 

Class II and III:

 

  • Medical devices should either be reviewed by third-party certification body authorized by MHLW or

  • Reviewed by PMDA and approved by MHLW

 

Class IV:

Medical devices need to be reviewed by PMDA and approved by MHLW

 

In Japan, these 4 classifications are correspondence to the JMDN nomenclature. As the current GMDN nomenclatures cover multiple classes under the one nomenclature, PMDA requires to adjustment of the nomenclatures to fit with classification systems in PAL and therefore, JMDN was created and used in Japan.

 

Application process for Class II, III and IV by PMDA and third party certification body

 

The following illustrated the application type, documents and GMP conformity assessment to for Japan product approval.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Certain medical devices have clinical evaluation similar to Europe. The clinical trial data should be available and in some context, it has to be conducted in Japan.

 

Early planning is important during Medical Device design and development phases (MD3P) in Japan, not just the clinical evaluation requirements, but the preclinical testing is also incorporated with technical specifications that the manufacturer should not miss. Otherwise, the test reports may not be acceptable during the Japan product evaluation process.

 

Our ARQon team with an engineering background is also heavily involved in the product development work in MD3P for manufacturers and advising companies about the mandatory requirements that depend on the country to penetrate. Coupling with our active product registration globally, our experiences counted to facilitate the product approval process where the documents and the test reports submitted meet the Authority mandatory requirements.

 

Our team also presented in Japan to help with the product registration and planning of the clinical trial protocol with the PMDA if clinical trial has been determined required in Japan.

Example of Approval

Example of Approval

Source: MHLW

RESOURCES: 

Guidance Documents:

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