Recognised Foreign GMP Certificates
ISO 13485 (most widely used)
MFDS recognises ISO 13485:2016 certificates from certification bodies accredited by IAF MLA member accreditation bodies. Requirements:
- Certificate valid at time of application
- Scope includes the product types and manufacturing activities for the applied device
Country-specific GMP recognition
MFDS has entered GMP mutual recognition arrangements with certain countries. A GMP certificate from the national competent authority (e.g., TGA, European Authorised Representative GMP) of a recognised country may be accepted.
FDA inspection reports
A current FDA QSIT inspection report (EIR with no major findings) may support an application but is not always independently sufficient.
Critical: scope must match
Regardless of which certificate is used, the scope must specifically cover the device type being applied for. A "general medical devices" scope may not satisfy MFDS for a specific implantable device application.