Which approvals qualify for the recognition pathway
Published:
Only five reference regulators are recognised: US FDA, EU CE, UK MHRA, Japan PMDA and Korea MFDS.
The recognition (simplified) pathway shortens registration for devices that already hold an approval from a reference regulator. Under Resolution No. 738 the reference regulators are the United States FDA, the European Union CE marking regime, the United Kingdom MHRA, Japan's PMDA and Korea's MFDS.
An approval from any other authority does not open the recognition route; those devices follow the national pathway with a full dossier. Applicants should confirm that the approved device model, intended purpose and manufacturing site on the foreign certificate match the product presented in Uzbekistan — mismatches are the most common reason a recognition application is redirected to the national route.