最新消息

HONG KONG: EXPEDITED APPROVAL SCHEME FOR MEDICAL DEVICE LISTING APPLICATIONS EXPANDED TO INCLUDE CLASS B/C/D IN VITRO DIAGNOSTIC MEDICAL DEVICE - August/September 2024

HONG KONG: EXPEDITED APPROVAL SCHEME FOR MEDICAL DEVICE LISTING APPLICATIONS EXPANDED TO INCLUDE CLASS B/C/D IN VITRO DIAGNOSTIC MEDICAL DEVICE - August/September 2024

  • 2024-09-17 03:42:57

The Expedited Approval Scheme for Medical Device Listing Applications has been expanded to include Class B/C/D In Vitro Diagnostic Medical Devices. Eligibility criteria remain unchanged, while some additional regulatory agencies have been recognized. Applications must be submitted through Medical Device Information System and refers to both GN-02 and GN-06.

了解更多
THAILAND: GUIDELINE FOR EVALUATING DOCUMENTS FOR CLASS 2,3,4 MEDICAL DEVICES THROUGH CONCISE EVALUATION AND RELIANCE PROGRAM - APRIL/MAY 2024

THAILAND: GUIDELINE FOR EVALUATING DOCUMENTS FOR CLASS 2,3,4 MEDICAL DEVICES THROUGH CONCISE EVALUATION AND RELIANCE PROGRAM - APRIL/MAY 2024

  • 2024-05-07 08:47:38

Thai FDA has replaced its previous criteria for evaluating medical devices via expedited routes with new guidelines published in 2024. The aim is to streamline the evaluation process for Licensed and Notified medical devices (Class 2,3,4) while ensuring quality, efficiency, and safety. The announcement outlines criteria, documents required, and regulatory procedures for the Concise Evaluation and Reliance Program routes under expedited route review.

了解更多
MALAYSIA: Harmonised Classification of Medical Device in ASEAN. –January/February 2024

MALAYSIA: Harmonised Classification of Medical Device in ASEAN. –January/February 2024

  • 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.

了解更多
TAIWAN: TFDA NOTICE: AMENDMENT ON “REGULATIONS GOVERNING THE CLASSIFICATION OF MEDICAL DEVICES”– OCTOBER/NOVEMBER 2023

TAIWAN: TFDA NOTICE: AMENDMENT ON “REGULATIONS GOVERNING THE CLASSIFICATION OF MEDICAL DEVICES”– OCTOBER/NOVEMBER 2023

  • 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.

了解更多
SINGAPORE: HSA IS RECOGNIZED BY WHO AS STRINGENT REGULATORY AUTHORITY (SRA) FOR CLASS C AND D IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVD) - JULY/AUGUST 2023

SINGAPORE: HSA IS RECOGNIZED BY WHO AS STRINGENT REGULATORY AUTHORITY (SRA) FOR CLASS C AND D IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVD) - JULY/AUGUST 2023

  • 2023-07-21 02:32:25

Singapore's Health Science Authority (HSA) is pleased to announce their status as a recognized Stringent Regulatory Authority (SRA) for Class C and D IVD by WHO. The SRA status means high-risk IVD products registered with HSA might obtain faster evaluation through WHO prequalification assessment, enabling manufacturers accelerated access to global markets.

了解更多