The Medical Device Authority (MDA) is set to enhance its application process by transitioning to a fully online system for advertisement...

The National Pharmaceutical Regulatory Agency (NPRA) is set to introduce key initiative aimed at strengthening the quality monitoring of...

The National Pharmaceutical Regulatory Agency (NPRA) has introduced a progressive initiative to improve the regulatory process for...

Effective 19 November 2024 , the National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 16/2024, announcing the...

The National Pharmaceutical Regulatory Agency (NPRA) recently released an update of the Drug Registration Guidance Document (DGRD) to...

Medical Device Authority (MDA) only recognized EC Certificate (CE Marking) issued under Directive 90/385/EEC, 93/42/EEC, or 98/79/EC, or,...

The Medical Device Authority (MDA) released an announcement on 31 May 2024 about the revocation of the MDA Circular Letter...

Based on the General Directive of the Minister of Health No.1/2024 , announced on 15 April 2024, following the provisions of the Medical...

Medical devices for importation, exportation, or being placed in the Malaysian market are obligated to register with the Medical Device...

Singapore Industry is preparing for Product, Importer/Wholesaler Licence with GDPMDS compliance where HSA is looking at transition period...

This is the latest gazettement of the Medical Device Regulations pursuant to the Medical Device Act 2012 (Act 737). The gazettement took...

This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their...

Control Of Orphaned, Obsolete and Discontinued Medical Device In Hospital, Healthcare Facilities Institution Or Any Related Facilities...

Date 12 February 2020 (Wednesday) | 8.00 AM – 5.30 PM (TRAINING) 13 February 2020 (Thursday) | 8.00 AM – 10.30 AM (EXAMINATION) Venue...

In September 2019, Malaysia halal medical device standard is published, known as: MS 2636 : 2019 Halal Medical Device - General...

Australia: Proposed changes to the Essential Principles for safety and performance Australia: Proposed changes to the requirements for...

Non-corrective contact lens is regulated as medical devices by the Medical Device Authority (MDA). According to the Medical Device...

MDA announced the training for competency module (regulatory requirements) for biomedical technical personnel. The module is designed to...

Australia: 2019 fees and charges released by the Therapeutic Goods Administration Australia: Conformity assessment standards for medical...

Circular Letter No. 1 Year 2019: Post-market Responsibility for Manufacturer and Authorized Representative Who Have Closed Their...