Medical Device Registration & Sales Support
Regulatory Affairs & Compliance Services
Compliance Service for Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (PMD Act)
Would you like to launch your products in Japanese market?
We solve the challenges faced about Marketing Authorization Holder (MAH) for Medical Device.
One-Stop Support for PMD Act by Taiwan and Japan teams
Our teams in Taiwan and Japan work together to provide a one-stop support for everything needed to enter the Japanese market, primarily serving manufacturers in Taiwan and overseas: Product Classification Consulting, MAH Agency Service, PMD Act Submission, Domestic Logistics in Japan, Warehouse Coordination, Sales Channel Introduction. Our team of experts, well-versed in both Taiwan’s TFDA regulations and Japan’s PMD Act, will help you enter the market in the shortest time and at the lowest cost, maximizing your return on investment.
Are you facing these issues?
I have a buyer in Japan, but I was asked to submit my MAH certificate.
It is unclear which Japanese laws apply to our products.
The PMD Act process is complex, and we don’t know where to start.
We do not have a Japanese subsidiary and cannot obtain the necessary approvals on our own.
Services
MAH Agency Service: The Japanese team handle the matter as the legally responsible entity.
PMD Act Submission: Support from document preparation to submission to the Ministry of Health, Labour and Welfare.
Product Classification Consulting: Determining the Classification of Medical Devices
Domestic Logistics and Warehouse Coordination (Further consultation is needed)
Sales Channel Introduction (Further consultation is needed)
Applicable Products
Medical Devices (General Medical Devices / Controlled Medical Devices)
Please feel free to contact us even if you are unsure of the classification.
Our Strengths
No language barriers due to our headquarter in Taiwan
Expertise in both Taiwan TFDA and Japan PMD Act
Practical support provided by our Japanese subsidiary
Business operations conducted in English and Chinese
Service Flow
Applicable Products:
Medical Devices (General Medical Devices / Controlled Medical Devices)
Application Under the PMD Act in Japan
When entering the Japanese medical device market, it is necessary to submit regulatory applications in accordance with Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (PMD Act). We explain the roles and application procedures established for each certification.
Medical Device Marketing Authorization Holder (MAH) and Medical Device Designated Marketing Authorization Holder (DMAH)
In order to sell products from overseas manufacturers in Japan, the manufacturer must first obtain certification as a “foreign manufacturer”. Then, “Medical Device Marketing Authorization Holder” submit regulatory applications to the Pharmaceuticals and Medical Devices Agency (PMDA) on behalf of overseas manufacturers to obtain approval for sales in Japan. There are two types of medical device marketing authorization holders: standard marketing authorization holder (MAH) and designated marketing authorization holders (DMAH). In the case of an MAH, the MAH submits the application and also serves as the MAH. In the case of DMAH, the applicant is a foreign manufacturer, and the approval itself is granted to that foreign manufacturer. This is referred to as a “foreign special approval”. Since the manufacturer holds the approval related to the application, there is no need to rely on a MAH thereafter.