GLGlossary
Manufacturer and manufacturing site.
The company that actually makes the device (the manufacturer) and the location where that production takes place (the manufacturing site).
These are basic details recorded on the certificate and in the product labeling, and for imported devices the overseas manufacturer's details have to be confirmed and stated as well. Where production is subcontracted, or where different processes are carried out at more than one site, the role of each site and the relationship between them must be set out in the documentation, and what is required can vary with the product and the production structure. A change of manufacturing site can trigger a change approval or change notification, so it is safer to check in advance.
Related work & timing
This is one of the first things fixed when the application is drafted and the scope of the KGMP audit is set. The more the production is subcontracted or spread across countries, the longer this takes to pin down.
Basis
- Enforcement Rule of the Medical Device Act (Korea) — Manufacturing/import approval applications and required particulars
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.
Other terms
← Back to glossary- Regulatory approval
- Classification (device class)
- Technical documentation
- KGMP (manufacturing and quality management standard)
- Test report
- Clinical evaluation
- Import and manufacturing business
- Post-market management
- Certification body / review body
- Labeling and advertising
- ISO 13485
- Identical, equivalent, and improved devices
- UDI (Unique Device Identification)
- CB test report
- Validation
- Risk management