Medical Device Exports During Administrative Sanctions or After GMP Expiry.

A suspension of manufacturing or importing prohibits the affected activity, while domestic sales and exports may remain possible. A sales suspension allows manufacturing and importing but prohibits domestic sales. Export eligibility requires case-specific assessment because the legislation and MFDS interpretations may differ.

Key Requirements

• Manufacturing/import suspension: The affected devices cannot be manufactured or imported; domestic sales and exports may remain possible.
• Sales suspension: Manufacturing/importing may continue, but domestic sales are prohibited. Exports are generally restricted, with differences in interpretation.
• Expired GMP certification: Manufacturing/importing and exports may remain possible, but domestic sales are prohibited.
• Export-only devices may follow simplified registration procedures; an export-only import authorisation may also be available.

Practical Implications

• Exports and domestic sales have different legal definitions, so exports may be possible under specified conditions despite an administrative sanction or expired GMP certification.
• The circumstances may require an MFDS interpretation or legal review, and separate export-only manufacturing or import authorisation may be needed.
• In particular, differing interpretations of exports during a sales suspension may lead to legal disputes.

Conclusion

• Exports may remain possible in some circumstances involving administrative sanctions or expired GMP certification. Consult MFDS or legal counsel to determine the permitted scope of activities.
• Before exporting, review the relevant legislation and administrative guidance to manage regulatory risks.

Contact BCG for further information.