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...
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ARQon
5 days ago2 min
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...
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ARQon
Sep 251 min
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...
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ARQon
Sep 231 min
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...
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ARQon
Sep 113 min
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...
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ARQon
Sep 102 min
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...
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ARQon
Sep 42 min
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,...
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ARQon
Aug 281 min
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...
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ARQon
Aug 272 min
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)...
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ARQon
Aug 211 min
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...
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ARQon
Aug 201 min
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
Aug 141 min
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...
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ARQon
Aug 131 min
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...
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ARQon
Aug 72 min
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...
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ARQon
Aug 62 min
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...
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ARQon
Aug 11 min
Taiwan: TFDA Revolutionizes Cosmetics Industry with New GMP Standards
Starting on 1 July 2024, the Good Manufacturing Practise (GMP) Standards were implemented in the cosmetics industry, specifically for...
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ARQon
Jul 302 min
India: Requirement of Toxicity Studies for New Drugs, SNDs, and FDCs
On the 29th of July 2024, the Central Drugs Standard Control Organization (CDSCO) released new circular on the requirement for toxicity...
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ARQon
Jul 242 min
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 233 min
Ireland: Latest Insights about Windsor Framework (Q&A)
After the United Kingdom’s exit from the European Union, the UK and EU established the Windsor Framework, aiming to restore the smooth...
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ARQon
Jul 173 min
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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