GLGlossary
Import and manufacturing business.
The business qualifications required to import or manufacture medical devices for sale.
Separate from getting a product approved, these are the requirements the company handling the product must meet. The facilities and management system required differ depending on whether it is import or manufacturing. A structure suited to your company's situation can be advised through consultation.
Related work & timing
Separate from product approval, this is a license the company itself must hold, and preparing it involves meeting requirements such as facilities and a quality manager. It is also addressed as part of our import and certification structure design service.
Basis
- Medical Devices Act — Article 6 (Manufacturing Business License) and Article 15 (Import Business License)View source →
- Enforcement Rule of the Medical Devices ActView source →
The references shown are for guidance; confirm the exact, current requirements against the source text and through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.