• 2023-06-28 07:35:36

HSA would like to consult the industry/stakeholders regarding updates and revisions of GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (R3). The key update includes clarification notes on the classification of control materials and software, also clarifications to the risk classification rules 1-5. The consultation period is open from 2-30 May 2023 through email to HSA.

• 2022-12-27 05:30:57

To promote an effective reviewing procedure, Thai FDA granted that therapeutic medical devices shall be classified and registered under Listing (Class 1 medical device), in effect from 3rd December 2022 onward.

• 2022-10-25 06:38:16

The MDA published the First Edition of the Guidance Document of the "Harmonized Classification of Medical Devices in ASEAN" (MDA/GD/0062) on September 5, 2022. This guidance document provides the harmonized list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices, based on their intended use or purpose as claimed by the manufacturer.

• 2022-06-29 02:30:03

The termination of Thai FDA's "Pre-Submission" resulted in the establishment of a new route to determine product risk classification and medical device grouping via the E-submission system.

• 2020-10-21 02:06:33

CDSCO has issued draft of new risk-based classification lists for previously non-notified general and IVD medical devices, in order to clarify regulatory pathways and requirements.

• 2020-06-16 08:03:29

This draft of medical device definition for manufacturers and importers to follow when registering their medical devices according to risk-based classification, to emphasize the milestone transition of Thailand away from policy-based classification.

• 2020-02-21 07:04:40

Thai FDA clarifies 3 types of classification of non-in vitro medical device, Licensed medical device, Notified medical device, and General medical device regarding risk assessment. And for In-vitro medical device, the product is classified from class 1 to class 4.

• 2020-05-06 09:11:58

MOH established a Medical Device Risk Classification System on the MOH website called SIKLARA. This system aims to facilitate applicants in classifying medical devices and minimalize errors in class determination. However, this system is only available in Indonesian.

• 2020-05-06 07:48:03

The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products scheduled for notification and regulation as medical devices starting April 1, 2020.

• 2020-02-14 07:27:45

Thai FDA announces that they will modify the Medical Device Act and will be adopting the international risk classification method (Class I-IV) in order to comply with the ASEAN Agreement on Medical Device Directive.