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Singapore: HSA Recognized Under WHO Prequalification Program for IVD Industry
On 15 June 2023, the Health Sciences Authority (HSA) of Singapore has been recognized by WHO as one of the stringent regulatory authority...

ARQon
Jun 21, 20231 min read


Denmark: Additional Criteria Requirement to Notify Medicines Supply Shortage
Medicines supply shortage in the healthcare market is an event that must be avoided from happening. The Danish Medicines Agency (DMA)...

ARQon
Jun 19, 20231 min read


China: 2023 Development Plan - Medical Device Registration Review Guidelines
The Centre for Medical Device Evaluation (CMDE) released a development plan for guidelines for the medical device registration in China...

ARQon
Jun 19, 20231 min read


UK: Timeline Extension of CE-Marked Medical Devices for the UK Market
The permitted of CE-marked medical devices in the UK under the regulations of Medical Device Regulations 2022 (UK MDR) will end on 30...

ARQon
Jun 16, 20231 min read


Malaysia: DNA Test Requirement for Final Biologic Products Containing Materials of Animal Origin
The Drug Control Authority (DCA) updated the Drug Registration Guidance Document (DRGD) on the requirements of DNA testing for final...

ARQon
Jun 15, 20231 min read


UK: Medical Devices Registration Guidelines for Great Britain & Northern Ireland Markets
Previous articles on The Windsor Framework discussed the human medicine deal arrangement between Great Britain and the Northern Ireland...

ARQon
Jun 14, 20234 min read


Australia: ISO 13485 Draw To An Ending Phase for IVD Medical Devices
Beginning on 26 May 2023, the Therapeutic Goods Administration (TGA) has stopped accepting ISO 13485 certificates as supporting evidence...

ARQon
Jun 12, 20231 min read


Singapore: Laboratory Developed Tests (LDTs) Regulatory Guidelines
Singapore's Health Sciences Authority (HSA) has issued draft guidelines on Laboratory Developed Tests (LDTs) from 12 July 2022 until 12...

ARQon
Jun 9, 20233 min read


Ireland: Post Brexit Deals Between UK and EU - The Windsor Framework (Human Medicines)
The Windsor Framework was proposed as a post-Brexit agreement to address the movement issue for goods between European Single Market and...

ARQon
Jun 8, 20232 min read


Switzerland: Mobile Technologies Guidance for Medicinal Product (QR Code)
Mobile technologies are accessible by anyone to search for information including people with disabilities. Mobile technologies come in...

ARQon
Jun 7, 20232 min read


Indonesia: Halal Certification For Drugs, Biological Products and Medical Devices
Ministry of State Secretariat of Indonesia promulgated the Presidential Decree 6/2023 for Halal Certification for Drugs, Biological...

ARQon
Jun 6, 20232 min read


Malaysia: MDA Published Third Edition Guidance for Medical Face Mask and Respirator
Since the world got hit by the Covid 19 pandemic, face masks and respirators were not mandatory only for healthcare workers but the...

ARQon
Jun 1, 20231 min read


India: CDSCO Reminds of the Medical Devices Class C & D of License Registration (30 September 2023)
All non-classified medical devices listed under Class C and Class D are authorized to undergo the licensing regime with full effect...

ARQon
May 31, 20232 min read


Saudi Arabia: SFDA Officially Joins PIC/S
On 12 May 2023, Saudi Food and Drug Authority (SFDA) officially approved being a part of the Pharmaceutical Inspection Co-operation...

ARQon
May 30, 20231 min read


Australia: Guidelines Update for Sunscreens by TGA
The Therapeutic Goods Administration (TGA) released updates for sunscreen regulatory guidelines in line with the proposed data...

ARQon
May 29, 20231 min read


Australia: TGA Recognition on EU MDR Transition
The European Union consented to extend the European Union Medical Device Regulation (EU MDR) transition based on the concerns proposed by...

ARQon
May 26, 20232 min read


Australia: EU MDR Transition: Overview of Australia Regulatory Framework Management
The transition between MDD into MDR certifications has affected a few requirements such as device classification, medical device...

ARQon
May 25, 20232 min read


Malaysia: Circular Update of GMP Requirements for CTIL Application for Foreign Manufacturers
The National Pharmaceutical Regulatory Agency (NPRA) published a circular on updating the Good Manufacturing Practice (GMP) requirements...

ARQon
May 24, 20231 min read


EC: SCHEER Opens Call for Information for Guidelines Updates on Phthalates in Medical Devices
The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) received requests from the European Commission to review...

ARQon
May 24, 20232 min read


Malaysia: The Removal of Incomplete Medical Device Registration and Change Notification Application
Medical Device Authority (MDA) of Malaysia released a statement on 23 March 2023 regarding the abortion of new or renewal medical device...

ARQon
May 22, 20231 min read
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