Medical device quality system certification is called Good Manufacturing Practice (GMP).
GMP certification, commonly referred to as ISO 13485 certification, is a process managed by a medical device manufacturer over the life cycle of the medical device, from the development of the device to the post-production stage, including disposal.
There are many countries that can be licensed with ISO 13485 certificates, but some countries require quality certification by country based on ISO 13485 certificates,
For example, Korea must obtain a KGMP certificate separately from the ISO 13485 certificate to proceed with the licensing process, and Canada requires an MDSAP certificate.
The table below provides information on which countries to certify ISO 13485 certificates and which countries to not certify themselves.
| Country | ISO 13485 certificate recognition status |
| U.S - FDA | X (21 CFR Part 820) |
| EU - CE MDR | O (ISO 13485) |
| Canada - Health Canada | X (MDSAP) |
| Korea - MFDS | X (KGMP) |
| Brazil - ANVISA | X (BGMP) |
| China - NMPA | X (IMP) |
| Maxico - COFEPRIS | O (ISO 13485) |
| Peru - DIGEMID | O (ISO 13485) |
| U.K - UKCA | O (ISO 13485) |
| Switss - Swiss Medic | O (ISO 13485) |
| 호주 TGA | O (ISO 13485) |
| Australia - MEDSAFE | O (ISO 13485) |
| Russia - EAEU | O (ISO 13485) |
| Japan - PMDA | X (ordinance #169) |
| India - CDSCO | O (ISO 13485) |
| Saudi Arabia - SFDA | O (ISO 13485) |
| Malaysia - MDA | O (ISO 13485) |
| Taiwan - TFDA | O (ISO 13485) |
| Philippine - Philippine FDA | O (ISO 13485) |
| Singapore - HSA | O (ISO 13485) |
| Vietnam - DMEC | O (ISO 13485) |
| Thailand - Thailand FDA | O (ISO 13485) |
| Indonesia - MOH | O (ISO 13485) |
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