• 2023-01-19 01:28:15

As we are easing into the first quarter of 2023, we are thus simultaneously entering into the last phase of Thai FDA grace period regarding the transition to the risk-classification approach. Thus, Thai FDA has published a summary of the medical device categories on their official website instructing medical device registration via Full CSDT submission and Partial 2 Submission route.

• 2021-06-25 12:51:04

The guidance, released as Decision No. 2426/QĐ-BYT, was constructed according to AMDD and with reference to the guidance of Singapore and Malaysia, and applicable to medical devices Class B, C, D including in-vitro diagnostic IVD MD.

• 2020-02-12 15:57:24

It is divided into 12 distinct parts, wherein the 3rd to 11th parts include technical documentations with the following main sections (a) the safety& effectiveness checklist (b) summary of the device (c) research study (d) manufacturing process, (e) clinical evaluation study (f) risk management report (g) technical requirements (h) test reports, and (i) IFU and labels.

• 2020-02-12 15:58:33

For the registration of any medical device with most regulatory authorities around the world, the first step would be to prepare the device’s technical documentation or a dossier. Technical documentation are the documented evidence, normally an output of the quality management system,

• 2020-02-12 15:58:33

For the registration of any medical device with most regulatory authorities around the world, the first step would be to prepare the device’s technical documentation or a dossier. Technical documentation are the documented evidence, normally an output of the quality management system,