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Canada: Key Guidelines to Crafting an Effective CAPA Plan by Health Canada
Health Canada releases step-by-step guidance on developing an effective Corrective and Preventive Action Plan (CAPA), consisting of three...

ARQon
Dec 2, 20241 min read


Vietnam: Addressing Import License Expirations in Vietnam (by 25 December 2024)
On behalf of the Ministry of Health of Vietnam, the Infrastructure and Medical Device Administration (IMDA) has requested all related...

ARQon
Dec 2, 20241 min read


Malaysia: NPRA Bans Chloroform and Chloroform Spirit as Preservatives (w.e.f. 19 November 2024)
Effective 19 November 2024 , the National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 16/2024, announcing the...

ARQon
Nov 27, 20242 min read


Australia: Key Deadlines for Patient-Matched Medical Devices (PMDDs)
The Therapeutics Goods Administration (TGA) has established a transition period to facilitate smooth transitions and allows continued...

ARQon
Nov 26, 20242 min read


Thailand: Guidelines for Document Referencing, Transfers, & Compliance in Medical Device Applications (w.e.f. 20 September 2024)
In alignment with the guidelines for licensing requests or notifications of medical device details by individuals, entities, or...

ARQon
Nov 20, 20242 min read


Nigeria: Zero VAT on Pharmaceuticals and Medical Devices
On the 9 October 2024, the Nigerian Federal Ministry of Health and Social Welfare has finalized an Executive Order implementing zero...

ARQon
Nov 13, 20241 min read


Indonesia: New Requirements for Medical Device Distributors Licensing Compliance (w.e.f 1 January 2025)
The Ministry of Health of Indonesia has introduced new guidelines for medical device distributors to enhance regulatory compliance,...

ARQon
Nov 12, 20241 min read


Belgium: Reminder End of Transition Period & Important Year-End Deadlines for Submitting Dossiers to the FAMHP
End of Transition Period for Clinical Trials FAHMP reminds all stakeholders, that starting from 31 January 2025 , all clinical trials...

ARQon
Nov 6, 20241 min read


Switzerland: Swissmedic Enhances Fast-Track and Temporary Authorization Processes for Human Medicine (w.e.f 15 Oct 2024)
Swissmedic, the Swiss regulatory authority for therapeutic products, has introduced updates to its guidance documents for the Fast-track...

ARQon
Nov 5, 20242 min read


New Zealand: Rollout New Life Changing Medicines for Public Health (w.e.f 1 October 2024)
In a significant advancement in healthcare, Pharmac, Te Aho o Te Kahu | Cancer Control Agency, Ministry of Health and Health New Zealand...

ARQon
Oct 30, 20241 min read


US: FDA’s DSCSA Exemptions, Waiver, & Exception
FDA’S Exemptions Granted to Trading Partners The U.S. Food and Drug Administration (US FDA) recently announced broad exemptions under the...

ARQon
Oct 29, 20242 min read


Australia: Critical Challenge for Medical Devices Due to 3G Network Shutdown
Starting on 28 October 2024 , both Telstra and Optus will be shutting down their third-generation (3G) networks. This follows the earlier...

ARQon
Oct 22, 20241 min read


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
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