{"id":17773,"date":"2021-03-25T10:32:32","date_gmt":"2021-03-25T09:32:32","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=17773"},"modified":"2023-01-24T14:59:01","modified_gmt":"2023-01-24T13:59:01","slug":"new-thai-fda-rules-device-classification-registration","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2021\/03\/25\/new-thai-fda-rules-device-classification-registration\/","title":{"rendered":"THAILAND: new THAI FDA rules on device classification and registration"},"content":{"rendered":"\n

The Thai Food and Drug Administration (Thai FDA) has issued new rules <\/strong>on classification <\/strong>and registration\n<\/strong>of Medical Devices and IVDs. <\/p>\n\n\n\n

\"New
New THAI FDA rules on device classification and registration<\/figcaption><\/figure>\n\n\n\n

New Medical Device and IVDs classification<\/strong><\/h2>\n\n\n\n

The new regulations\nprovide for 4 classes of risk <\/strong>(unlike\nthe previous 3) and they apply to both Medical Devices (DM) and in Vitro\nDiagnostic Medical Devices (IVD). <\/p>\n\n\n\n

The following table summarises the new classification: <\/p>\n\n\n\n
Previous classification <\/strong> <\/td>New classification<\/strong> <\/td>Effective date<\/strong> <\/td><\/tr>
General <\/td>Class 1 – Insertion <\/td>17 March 2021 <\/td><\/tr>
Notified <\/td>Class 2 \u2013 Notified
Class 3 \u2013 Notified <\/td>
15 February 2021 <\/td><\/tr>
Licensed <\/td>Class 4 \u2013 License <\/td><\/tr><\/tbody><\/table>\n\n\n\n

Impact on Medical Device and IVD Registration <\/strong><\/h2>\n\n\n\n

The documentation for the\napplication for registration <\/strong>must now be submitted in two steps, with the\npossibility to evaluate the grouping into systems, sets, kits and families for\ndevices of all classes. In particular the defined steps are: <\/p>\n\n\n\n