China Clinical Requirements Update On 13th December, the CMDE published the Public Consultation (Deadline: 13 Jan 2020) on “Technical...

Singapore Launch of OSCAR System for FSCA Reporting As part of HSA’s on-going effort to improve efficiency in our processes, HSA is...

Breast Implant regulation: B.E. 2562 Main content revision from regulation B.E. 2540 Signed date: 7 November 2019 Announced date: 18...

Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft for Software Developer and Software in...

Singapore HSA ‘Regulatory Guidelines for Software Medical Devices – A lifecycle approach’ Draft for Software Developer and Software in...

WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (WHO SAGE IVD) The World Health Organization (WHO) has established a...

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

The ASEAN Cosmetic Directive (ACD) is an agreement among ASEAN countries to harmonize the requirements of cosmetic products so as to...

ARQon shared industry view in ASEAN meeting 5 years back on having recognition like Hague Apostille Convention, finally came true....

MDR 'Up-Classified' Class I Medical device Extension European Parliament finalized the EU MDR Second Corrigendum following ENVI and INTA...

Thai FDA issued an announcement for alternative Concise Evaluation route for registering Notified and Licensed medical device, including...

MOH Indonesia published the Guideline for Consultation with MOH Directorate Medical device and House-hold product on 24 December 2019,...

The Vietnamese MOH has released the proposed amendment at the end of 2019 to the Vietnamese medical device industry while waiting for the...

Singapore Health Sciences Authority (HSA) final document presents the specific requirements applicable for NGS IVDs that are to be...

Following the consultation with industry since Aug 2016, the Singapore National Environment Agency (“NEA”) gazette additional controls...

Announcement made by Saudi Arabia SFDA in August hits the local registrants. In-country representatives as SFDA are closing all the...

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

EU: Commission Implementing Decision (EU) 2019/1396 on the designation of expert panels EU: Industry expresses concerns about proposed...

USA: FDA medical device user fees for fiscal year 2020 increase by almost 6% USA: Comments sought on possible exemption of powered...

Brazil: Requirements finalized for custom-made and patient-specific medical devices Brazil: Proposed changes to requirements for syringes...