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ARQon
15 hours ago2 min read
Finland: EU F-Gas Regulation for HFC-Containing Inhalers (w.e.f. 1 January 2025)
Effectively from 1 January 2025 , new regulatory requirements have come into effect for placing inhalation sprays containing...
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ARQon
2 days ago2 min read
Vietnam: Medical Device Import License Extended to 30 June 2025
The Ministry of Health of Vietnam (MOH) recently issued Decree No. 04/2025/ND-CP, introducing amendments and supplements to Decree No....
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ARQon
Dec 30, 20242 min read
Indonesia: Dried Blood Spot (DBS) Products Now Classified as Medical Devices (w.e.f. 9 December 2024)
Recently, the Ministry of Health of Indonesia announced that Kertas Saring, also known as Dried Blood Spot (DBS) , will be recognized as...
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ARQon
Dec 23, 20242 min read
Indonesia: Online Certification and Medical Device Licensing Systems to Close Temporarily
The Ministry of Health of Indonesia has temporarily closed the Medical Device Licensing and Online Certification Systems for scheduled...
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ARQon
Dec 11, 20241 min read
Singapore: HSA Launches Pilot for Change Management Program (CMP) Targeting SaMD and AI-Driven Innovations (w.e.f 4 December 2024)
Singapore's Health Sciences Authority (HSA) is taking a significant step toward modernizing regulatory frameworks with its pilot for the...
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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...
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ARQon
Nov 26, 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...
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ARQon
Nov 20, 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...
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ARQon
Nov 13, 20241 min read
Nigeria: Zero VAT on Pharmaceuticals and Medical Devices
On the 9Â October 2024, the Nigerian Federal Ministry of Health and Social Welfare has finalized an Executive Order implementing zero...
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ARQon
Nov 12, 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,...
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ARQon
Oct 22, 20241 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...
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ARQon
Oct 17, 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...
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ARQon
Oct 14, 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...
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ARQon
Oct 8, 20241 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...
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ARQon
Sep 23, 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...
22 views0 comments
ARQon
Aug 27, 20242 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)...
14 views0 comments
ARQon
Aug 21, 20241 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...
17 views0 comments
ARQon
Aug 20, 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...
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ARQon
Jul 24, 20242 min read
Hong Kong: Enhanced Measures Announced by DH for Medical Device Procurement Strategy
On the 4th of July 2024, the Department of Health (DH) announced its movement towards the second phase in enhancing the measures of...
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ARQon
Jul 17, 20243 min read
Australia: Navigating New Regulation Changes for Medical Devices
The Therapeutic Goods Administration (TGA) revised the medical device regulations and introduced the amendments on the 26th of June 2024....
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