Animals Medical devices are primarily regulated in Japan by the Law on Ministry of Agriculture, Forestry and Fisheries (MAFF) under Pharmaceutical and Medical Device Act.
A complex and difficult process is prepared for products to be placed on the market. RAPID will help you to get over that process smoothly and quickly as your marketing authorization license holder (DMAH).
RAPID supply all the services that are between your company and your client in Japan. Companies that want to export animals medical devices to Japan must obtain MAFF approval. Importers must comply with a set of MAFF procedures to import animals medical devices in Japan. Thanks to our expertise in MAFF -related fields we can work with your company to have your products approved for sale on the Japanese market.
If you have concerns that you do not know where you consult with us or you will enter the animals medical device industry from now on, please feel relieved to leave them to us.
RAPID provides free initial consulting advice.
Do you have such impression that “Regulatory affairs consulting are expensive”?
We can make a contract at an appropriate price (from 1 hour, monthly payment system and project-by-project basis) according to your company.
RAPID will always protect client confidentiality and will always provide honest and accurate answers. We follow a policy of ethics and transparency with our clients so that they, in turn, can approach regulatory authorities with the knowledge and confidence necessary to succeed.
RAPID provides DMAH services for companies who primarily enter the medical device industry to sell animals medical devices in Japan.
Application documents shall be submitted to the relevant governor since prefectural governors are authorized to license. The license is granted by the prefectural government after being reviewed of the conformity to GMP, GVP, etc.
In addition to the above, we will address the general business of regulatory affairs. Please feel free to contact us.
As there is a risk of a serious impact on the life and health of animals in the event of side effects or impairment of function, the appropriate management is required, and the Minister of Agriculture, Forestry and Fisheries designates specially controlled medical devices for animals by listening to the opinion of Pharmaceutical Affairs and Food Sanitation Council (Article 2, Paragraph 5 of the Act)
As there is a risk of an impact on the life and health of animals in the event of adverse effects or functional disorders other than specially controlled medical devices, and the Minister of Agriculture, Forestry and Fisheries designates specially controlled medical devices for animals by listening to the opinion of Pharmaceutical Affairs and Food Sanitation Council (Article 2, Paragraph 6 of the Act)
As there is a risk of an impact on the life and health of animals in the event of side effects or impairment of function other than Specially controlled medical devices and Management medical devices, the appropriate management is required, and the Minister of Agriculture, Forestry and Fisheries designates specially controlled medical devices for animals by listening to the opinion of Pharmaceutical Affairs and Food Sanitation Council (Article 2, Paragraph 7 of the Act)
For more information about RAPID services and inquiries, please feel free contact us.
Phone +81-50-5361-6640 9:00-17:00 Japan Standard Time