Singapore HSA Updates Multiple Medical Device Guidances
In July 2025, HSA launched the new online platform SHARE (Singapore Health Product Access and Regulatory E-System) for Medical Devices …
Australia TGA presents the UDI Launch Workshop (Sydney)
Are you a Sponsor or Manufacturer of a medical device on the ARTG? Are you aware of the Unique Device …
Minister of Finance of Vietnam Promulgates Circular Prescribing Fees in Medical Device Sector
Circular 59/2023/TT-BTC introduces regulations on fees in medical sector, and the collection, transfer, management and use thereof. Such fees in …
Singapore HSA Revises Medical Device Adverse Events Reporting Guideline
Singapore HSA revised GN-05: Guidance on the Reporting of Adverse Events for Medical Devices with the following update: – Included …
Singapore HSA Updates Medical Device Adverse Event Reporting Form
Singapore’s Health Sciences Authority (HSA) updated the Medical Device Adverse Event Reporting Form for Medical Device Dealers (MDAR1 Form). As …
Singapore HSA Accepts MDSAP certification for Medical Device’s QMS Certification
Singapore HSA included Medical Device Singapore Audit Program (MDSAP) certification as one of the acceptable lists of Medical Device’s QMS …
Singapore HSA Updates Guidance on the Risk Classification of IVD Medical Devices (GN-14)
Singapore’s Health Sciences Authority (HSA) has finalised the updated GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical …
Malaysia MDA Updates on the Approach to Expired EC Certificate for New Registration and Re-registration of Medical Device
MDA has taken an approach to allow expired EC Certificates to be used for conformity assessment procedures due to the …
Malaysia MDA Update on Transition Period for the Use of Electronic Medical Device Registration Certificate
Malaysia MDA released an update on the use of Electronic Medical Device Registration Certificate starting 2 May 2023. Establishment can …
More News
#pharmaceuticalindustry
#regulatoryaffairs
ASEAN
Australia
Biologics/Biosimilars
Canada
China
Clinical Trials
Cosmetics
CTGTP
eCTD
EU
Global
Health Supplements
Herbal/Traditional Medicines
Hong Kong
India
Indonesia
Japan
Malaysia
Medical Devices
New Zealand
Pharmaceutical Drugs
Philippines
regulatory
regulatoy
Singapore
South Korea
Sri Lanka
Switzerland
Taiwan
Thailand
United Kingdom
United States
Vietnam