PMDA Certification Support
What is PMDA?
The PMDA (Pharmaceuticals and Medical Devices Agency) is a public agency in Japan responsible for the review, safety measures, and post-market safety management of pharmaceuticals and medical devices. Products intended for the diagnosis, treatment, or prevention of disease, or products intended to affect the structure or function of the body, may be classified as medical devices in Japan. In order to manufacture and sell such products in the Japanese market, depending on the product classification and specifications, notification to the PMDA, certification by a registered certification body, or approval from the Minister of Health, Labour and Welfare is required.
Main classifications of medical devices
Depending on the design and the level of risk to human health in the event of a malfunction, the products are broadly classified into four classes. The required procedures (notification, certification, and approval) differ significantly for each class.
🔹 Class I: General medical device (extremely low risk)
[Product Examples] Non-woven masks, surgical gloves, adhesive bandages, surgical instruments, etc.
[Required Procedures]
In principle, sales become possible by submitting a "manufacturing and sales notification" to the PMDA (Pharmaceuticals and Medical Devices Agency) (there is no third-party review).
🔹 Class II: Controlled medical device (relatively low risk)
[Product Examples] Electronic blood pressure monitors, home massagers, contact lenses, hearing aids, etc.
[Required Procedures]
Products for which the government sets standards require "third-party certification" by a registered certification body.
For products for which there are no established standards, it may be necessary to apply for approval from the government (Minister of Health, Labour and Welfare).
🔹 Class III: Highly controlled medical device (relatively high risk)
[Examples of products] Hemodialysis machines, injection needles, infusion pumps, contact lenses (currently classified as Class III in Japan), etc.
[Required Procedures]
Some products are subject to certification by a registered certification body.
Other products must undergo a rigorous review by the PMDA and obtain "approval" from the Minister of Health, Labour and Welfare.
🔹 Class IV: Highly controlled medical device (directly related to life support and extremely high risk)
[Examples of products] Cardiac pacemakers, artificial heart valves, coronary artery stents, artificial joints, etc.
[Required Procedures]
In principle, it is necessary to undergo the most advanced technical and scientific review by the PMDA and obtain "approval" from the Minister of Health, Labour and Welfare.
Main support services
1. Product Classification and Applicability Survey
We will review the product's intended use, efficacy, specifications, and advertising claims to determine if it qualifies as a medical device in Japan, and if so, to identify its intended classification and the necessary procedures.
2. Support for business qualifications and organizational development
We provide support for the necessary licenses, registrations, and system development required depending on your business type, such as registration as a manufacturer or distributor in Japan, or as a foreign manufacturer.
3. Support for product notification, certification, and approval applications
We organize product specifications, technical documents, clinical evaluation data, and QMS-related materials in preparation for applications to the PMDA or registered certification bodies, and coordinate with relevant parties in both Chinese and Japanese.
4. Consistent support provided by Chinese-Japanese bilingual staff.
We act as an intermediary between Chinese factories, Japanese manufacturers and distributors, testing laboratories, and certification bodies, providing comprehensive support including translation of technical documents, checking for missing documentation, managing application schedules, and responding to inquiries.