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...

AHWP: Proposed competency framework for medical technology regulators IMDRF: Principles and practice for medical device cybersecurity are...

It was confirmed by the European Commission on 30 October 2019 that the Medical Device Regulation (MDR) EUDAMED will be delayed for two...

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...

Albania: Amendments proposed to ‘Law on Medical Devices’ EU: New MDCG documents on Notified Bodies, the person responsible for regulatory...

Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting...