Support for importing and marketing foreign made medical devices
- Since we hold licenses for 1st class marketing authorization, medical device manufacturer, specially controlled medical device distributor/leasing, it is possible for us to import foreign made devices, to store finished products, to distribute them in Japanese market.
- For those who wish to import foreign medical device, our regulatory affairs division will help to acquire the status of marketing approval, certification, and/or notification for the products.
- Quality inspection of the imported products can be done at our manufacturing site. Qualified products will then be packed with appropriate labels and package inserts accordingly. After making product release decision, the products will be able to be marketed. As for distribution, it can also be done by those who obtain a distribution/leasing license for medical device.
(You may also want to take a look at the web site of Tokyo Metropolitan Government for more details.)
Workflow for importing medical device into Japan
- Prior to obtaining licenses
- Drafting applications for a product approval, a certification, a notification
- Prior to obtaining licenses
- QMS conformity (only required when obtaining a product approval and/or a certification)
- After obtaining licenses
- Importing procedure, quality inspection, labelling and packaging, storing the finished products
- After obtaining licenses
- Making product release decision
- After obtaining licenses
- Marketing the products (to distributors or to hospitals)
What roles are we taking part under each license?
As a manufacturer
Quality Inspection / Labeling / Warehouse
Careful quality inspection, based on requirements for each product, will be done by operators who regularly receive trainings.
After labeling and package inserts are set, qualified products will be stored at our site.
As a 1st class market authorization license holder
Making a product release decision for domestic market
In order to market a medical device in Japan, it is required to have a Marketing Authorization Holder or Designated Marketing Authorization Holder make a product release decision permit.
Post-marketing actions
- Quality Assurance
We will regularly make non-conformance reports, improvement requests, other necessary liaisons to foreign manufacturers. - Maintaining GVP system
After a product being released in the market, we will collect safety information and handle complaints.
