• 2026-07-27 01:56:36

On June 1, 2026, the NMPA issued an announcement to further clarify the work related to registration and filing following the adjustment of the management classification category of medical device products. The announcement covers various scenarios, including initial registration, renewal registration, and change registration, and sets forth corresponding requirements for the production, distribution, and import of the products.

• 2025-12-26 03:31:27

The Malaysian Medical Device Authority (MDA) has implemented a Product Classification Letter with a two-years (2) validity in alignment with regulatory requirements. Letters issued before specified dates may expire or require renewal under the updated framework.

• 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 04:28:54

The NMPA's new IVD Reagent Classification Catalog, effective January 1, 2025, introduces a standardized classification code format for streamlined registration. The update replaces the previous system, requiring compliance with the "6840-XX-XXXXX" format and providing guidelines for multiplex and unclassified products. Early preparation is essential to avoid approval delays.

• 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.

• 2024-06-20 06:13:07

The TGA's new "Examples of Boundary and Combination Products" clarifies how to classify complex goods that blur the lines between medicines, medical devices, and biologicals. This list includes common products like injectable fillers and contact lens solutions.

• 2024-01-26 06:58:53

This guidance explains the qualification and classification of products without an intended medical purpose listed in Annex XVI of the MDR.

• 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.