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Singapore: Cybersecurity Labelling Scheme Presents a New Standard for Medical Devices
On 16 October 2024, the Cybersecurity Labelling Scheme for Medical Devices (CLS [MD]) was officially launched, following a successful...
ARQon
Oct 17, 20241 min read
India: CDSCO Secures IMDRF Affiliate Membership
In a major step towards strengthening its medical device regulatory framework, India’s Ministry of Health and Family Welfare has...
ARQon
Oct 15, 20241 min read
Thailand: Wound Dressings Under Medical Device Perspectives
The Thailand Food and Drug Administration (TFDA) has released an infographic outlining the classification of wound dressings as medical...
ARQon
Oct 14, 20241 min read
SIMPLIFYING THE KEY OBLIGATIONS UNDER SINGAPORE PERSONAL DATA PROTECTION ACT (PDPA)
Learn how we simplify the key privacy obligations for businesses and provide tips on helping businesses get started What You Need to Know...
ARQon
Oct 10, 20242 min read
New Zealand: New Vaping Regulations on Removable Batteries and Child Safety Requirement Set for 1 October 2024
Starting 1 October 2024 , retailers, manufacturers, and importers will be prohibited from selling or stocking vaping devices without...
ARQon
Oct 9, 20242 min read
Hong Kong: Revised Guidelines for Processing Application Renewal of Listed Medical Device (w.e.f 1 January 2025)
On 30 September 2024, the Medical Device Division (MDD) of Hong Kong introduced an updated procedure for processing renewal applications...
ARQon
Oct 8, 20241 min read
Singapore: SG-HSA eCTD Specification Package v1.0 (w.e.f 25 September 2024) and SHARE Portal Launching 7 October 2024 for Class 2 CTGTP Registration
The Health Sciences Authority (HSA) of Singapore released regulatory updates at the end of September 2024. The updates involve...
ARQon
Oct 1, 20242 min read
Malaysia: NPRA Updates Drug Labeling Requirements for Animal-Derived Ingredients
The National Pharmaceutical Regulatory Agency (NPRA) recently released an update of the Drug Registration Guidance Document (DGRD) to...
ARQon
Sep 25, 20241 min read
Indonesia: Mandatory GDP Certification for Medical Devices in the e-Katalog (w.e.f 1 January 2025)
The Ministry of Health of the Republic of Indonesia released a circular no. HK.02.02/E/1753/2024 to address the implementation of the...
ARQon
Sep 23, 20241 min read
Philippines: DOH Guidelines for the Registration of Pharmaceutical Products and Active Pharmaceutical Ingredients Exclusively for Export
On 19 August 2024, the Department of Health of the Philippines issued Administrative Order No.2024-0012, outlining the regulations for...
ARQon
Sep 11, 20243 min read
NGBA: Latest Import Regulations for Drugs and Medical Devices from Hong Kong and Macao into the 9 Cities of the Greater Bay Area (w.e.f 1 December 2024)
The Standing Committee of the 14th Guandong Provincial People’s Congress has adopted revised regulations for managing the importation of...
ARQon
Sep 10, 20242 min read
Malaysia: MDA Introduces Updated Guidelines for Medical Device Registrations with Expired EC Certificates and Self-Declared Class B IVDs
Medical Device Authority (MDA) only recognized EC Certificate (CE Marking) issued under Directive 90/385/EEC, 93/42/EEC, or 98/79/EC, or,...
ARQon
Sep 4, 20242 min read
Thailand: TFDA Releases Guidance on Diagnostic Test Registration for Monkeypox
On 20 August 2024, the Medical Device Control Division of TFDA released registration guidance for monkeypox (Mpox) diagnostic tests as a...
ARQon
Aug 28, 20241 min read
EU: Compliance for Portable Batteries and Waste Batteries in Medical Devices and IVDs (w.e.f 18 August 2024)
Under the European Union (EU) Battery Regulation 2023/1542, released last year, all medical device and in-vitro diagnostic device (IVD)...
ARQon
Aug 27, 20242 min read
Australia: Prescription Lenses and Their Exemption from Medical Device Classification (15 June 2024)
Compliance effective on 15 June 2024 , prescription lenses for refractive correction are exempted from the requirement for inclusion in...
ARQon
Aug 21, 20241 min read
Vietnam: DMEC Publishes Decision No.2302/QD-BYT - Guidelines for Evaluation of Legal Documents in Class C and D Medical Device Registration Dossiers
As published by the DMEC of MoH Vietnam on 5 August 2024, Decision No. 2302/QD-BYT will replace Decision No.3007/QD-BYT regarding...
ARQon
Aug 20, 20241 min read
PIC/S: Revised PIC/S GMP Guide on Manufacture of Sterile Products (Lyophilization - w.e.f 25 August 2024)
Annex 1 of the PIC/S Good Manufacturing Practise (GMP) Guide on the manufacture of sterile products has been revised and published. The...
ARQon
Aug 14, 20241 min read
India: CDSCO Announces New Updates to Cosmetic Division Affecting the SUGAM portal (w.e.f 16 August 2024)
Effectively starting 16 August 2024 , all stakeholders are reminded to note that the number of application submissions into the...
ARQon
Aug 13, 20241 min read
China: NIFDC Announces New Technical Guidelines for Cosmetic Stability, Preservative Challenge, and Packaging Compatibility Testing and Evaluation
The National Institutes for Food and Drug Control (NIFDC) formulated three new technical documents to facilitate the industry in cosmetic...
ARQon
Aug 7, 20242 min read
Singapore: Key Updates for Therapeutic Product Registration (w.e.f 1 Aug 2024)
The Therapeutic Products Branch (TPB) of the Health Science Authority (HSA) has announced the latest updates on regulatory procedures, as...
ARQon
Aug 6, 20242 min read
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