On August 25th, 2023, Qualtech hosted a webinar discussing the requirements of medical device registration in Japan, with a special emphasis on reliability inspection. The webinar was hosted by Ms. Irene Lu and Ms. May Huang, and they were joined by the company's in-house regulatory specialist for Japan, Ms. Ayaka Minamoto, who imparted her extensive expertise to a diverse audience of over 70 participants.

The webinar commenced with a brief overview of Japan’s process for medical device registration, followed by an introduction to its reliability inspection procedures. Subsequently, a comprehensive discussion delved into the specific requirements outlined by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the reliability inspection, covering both clinical and non-clinical evidence.

The process of registering medical devices in Japan involves five key players:

a)	foreign manufacturer
b)	local manufacturer
c)	designated marketing authorization holders (DMAHs)
d)	distributors
e)	the PMDA or the Regulatory Certification Body (RCB).

When a manufacturer wishes to bring a medical device to the Japanese market, they would need three certificates, namely a Foreign Manufacturing Accreditation (FMA), a product license, and a Quality Management System certification. Among these, the registration process for a medical device’s product license is the most rigorous, as the PMDA mandates a reliability inspection of the submitted test reports.

Throughout the inspection, the PMDA meticulously reviews a particular product dossier to examine whether its test reports align with the regulatory guidelines. For the documents to be considered reliable, the PMDA stipulates that the submissions must be accurate, complete, and preservable.

With the reliability inspection, PMDA will be examining the non-clinical and clinical evidence submitted for the medical device. During a non-clinical inspection, PMDA will inspect records relating to test protocol, primary documents, test results, and records of equipment calibrations. While clinical inspection involves the examination of whether the clinical trial was properly conducted, if the Case Report Form (CRF) was properly created, accurately reflects the database, and if unfavorable results were depicted, the general inspection framework of the two types can be seen in the figure below:

Through our August webinar, Qualtech has presented a detailed overview of the rigorous reliability inspection process conducted by the PMDA. With Qualtech's experienced guidance and support, you can navigate the intricate terrain of Japanese product registration with confidence, guaranteeing compliance with all regulatory mandates for your medical devices. Our commitment lies in delivering comprehensive and dependable registration services to streamline your market access and bolster your success.

For the latest promotions and events, please visit our Facebook page. If you have any inquiries or require assistance with Japanese product registration, don't hesitate to reach out to Ms. Irene Lu at irene@qualtechs.com.