• 2025-07-10 10:02:10

The Malaysia Medical Device Authority (MDA) has published the latest edition of Harmonised Borderline Products in ASEAN which provides an updated classifications list for products that may fall under medical device regulations across ASEAN member states. This update helps establishments to determine their products classification (medical device or non-medical device).

• 2025-02-21 03:51:47

Indonesia's Ministry of Health has reclassified Filter Paper, specifically Dried Blood Spot (DBS) Filter Paper, as a Medical Device. This significant change, effective December 9, 2024, requires manufacturers to register their products as medical devices through the Online Single Submission (OSS) system. This reclassification necessitates compliance with specific regulations and quality standards, impacting product registration and market access in Indonesia.

• 2024-01-26 05:03:01

The Medical Device Authority (MDA) published Second edition Guidance Document, on “Guidance on Harmonised Classification of Medical Device in ASEAN”, on December 12, 2023. This guidance document provides the harmonised list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on their intended use/ purpose as claimed by the manufacturer.

• 2023-10-20 08:44:59

NMPA adjusted the "Medical Device Classification Catalog", involving 58 Medical Device Classifications. Among the important adjustments are strengthening the management of soft tissue ultrasound heads and breast rotary cutting products.

• 2023-10-20 06:31:20

Recently, TFDA has announced an amendment to the classifications of medical devices. The scopes and identifications of several medical device classifications have been updated to provide more specific and clearer instructions. Among these, the risk level of 3 classifications has been re-determined and there are 11 new additional classifications.

• 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.

• 2023-03-27 09:59:19

This guidance addresses the classification of IVDs and provides clarification rules as set out under Annex VIII of the IVDR.

• 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.

• 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 07:05:56

This document provides borderline cases and classification cases, for which the competent authorities of the Member States find difficulty regarding the uniform application of the regulations.