For manufacturers considering exporting medical devices to Japan
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We will assist you in compliance with Japanese law and regulations.
Acoma’s 100 years of experience
Since 1921, we have been dedicated to the manufacturing and sale of medical devices, delivering innovative products with advanced functions to the medical field. We have been able to enjoy the patronage of our customers for a long time, and in 2021 we celebrated our 100th year in business.
Acoma is a group of experts in all aspects of the development, manufacture, and sale of our own products.
Acoma’s License
Acoma holds license of Type I Marketing Authorization Holders (MAH) for medical devices.
Acoma can handle all medical device categories (except in vitro diagnostic) in Japan.
Achievements
Main Products: Anesthesia system, Ventilator, Anesthesia circuits, Breathing circuit, etc.
Acoma is doing regulatory applications for approval, certification, manufacturing control, quality control, and post-marketing safety management on Japan’s Pharmaceuticals and Medical Devices Act (PMD Act).
Other Licenses
- Medical Device Manufacturer Registration
- Sell and Leasing Specially Controlled Medical Devices License
- Repairing Medical Devices License
- Veterinary Medical Devices Marketing Authorization License
- Sell and Leasing Specially Controlled Veterinary Medical Devices License
- Repairing Veterinary Medical Devices License
- ISO 13485:2016 Certification