Japan Medical Device Registration

Regulatory Authority

Pharmaceuticals and Devices Agency (PMDA)

PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour, and Welfare.

Our obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.

We conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety. We are also responsible for providing relief compensation for sufferers from adverse drug reactions and infections by pharmaceuticals or biological products.

Link for Regulatory Authority

https://www.pmda.go.jp/english/index.html

Local Regulation

Pharmaceutical and Medical Device Act (PMD Act)

Classification of Medical Devices

1. Medical Device

2. IVD

Listing or Registration Requirements

• Pre-market submission (Todokede)
  To register General Medical Devices (Class I), you must file a pre-market submission to the PMDA. This is a notification, and no review/assessment by the PMDA will be conducted.
• Pre-market certification (Ninsho)
  Class II (and a limited number of Class III) devices which have an associated certification standard (JIS), are subject to pre-market certification. Many, but not all, Japan Industrial Standards are based on existing ISO/IEC standards. Your MAH will file your application with a Registered Certification Body (RCB). The process is similar to the European CE Marking process where reviews are outsourced to a third party similar to a Notified Body.
• Pre-market approval (Shonin)
  Class II and III devices without a specific certification standard are subject to the pre-market approval process. This also applies to all Class IV devices. In this case your MAH will file a pre-market approval application with the PMDA and obtain approval from the MHLW.

Documents Required for Japan Medical Device Registration

Depends on the class of the device. In general, the documents required are:

• Development history (previous device versions, global authorizations)
• Product specifications
• Data on stability and shelf life
• Compliance with the applicable standards and essential principles
• Performance test data
• Risk analysis
• Manufacturing (process, supervision, sterilization)
• Clinical data

Registration Timeline

1 – 3 Years depending upon the class of the device

Registration Fee

No fee

License Validity

Indefinite

License Renewal

6 months before expiry date

Language Requirements

All documents submitted during the authorization procedure must be in Japanese.

Pharmacovigilance

In Japan, the oversight of post-marketing surveillance for medicinal products and medical devices falls under the purview of the Pharmaceutical and Medical Device Agency (PMDA), working in collaboration with the Ministry of Health and Labour Welfare (MHLW). They employ a unique three-pillar safety system that encompasses the safety review of medicinal products, post-marketing safety measures, and relief services for adverse health effects. 

Adverse event reporting in Japan is voluntary, with healthcare professionals able to submit reports via email, fax, or post, while the public can utilize the website for reporting. Marketing Authorizing Holders (MAH) have the option to report through electronic transmission, post, or in person. The collected data undergoes scientific analysis to investigate causal relationships, and the resulting investigation report is submitted to the MHLW for further actions to ensure the safety of pharmaceuticals and medical devices. 

Japan has recently incorporated innovative techniques such as data mining methods and sentinel institution networks to enhance the accuracy and speed of responses, aiming to proactively address and predict safety concerns. Additionally, information regarding the appropriate usage of medicines and medical devices is readily accessible on the website for patient reference.

Who should make this Communication?

• Manufacturer
• Authorized Representative (Designated Marketing Authorization Holder – (DMAH))

When to make this Communication?

Before placing a medical device into the market.

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk

https://www.std.pmda.go.jp/stdDB/index_en.html  

https://www.std.pmda.go.jp/stdDB/index_en.html