top of page
.png)
Search
Australia: TGA Adopts 2021 Sunscreen Standard (w.e.f 1 July 2024)
Starting 1 July 2024, the Therapeutic Goods Administration (TGA) will adopt the 2021 Sunscreen Standard (Australian/New Zealand Standard...
ARQon
May 15, 20241 min read
Malaysia: Navigating Trade Barriers for Medical Devices in Nations without Diplomatic Ties
Medical devices for importation, exportation, or being placed in the Malaysian market are obligated to register with the Medical Device...
ARQon
May 14, 20241 min read
Hong Kong: MDD Introduces a One-Stop e-Service, Medical Device Information System (MDIS)
Medical Device Division (MDD) of Hong Kong introduced a new one-stop e-service platform for online application submissions for medical...
ARQon
May 8, 20241 min read
Brazil: ANVISA Announces to Extend B-GMP Certificates for MDSAP-Certified Medical Device Manufacturers (w.e.f 1 April 2024)
On 20 March 2024, ANVISA published Resolution RDC 850/2024 with an official announcement to extend the Brazil Good Manufacturing...
ARQon
May 7, 20241 min read
Philippines: South Korean MFDS as Reference Drug Regulatory Authority
On 29 April 2024, the Philippines FDA added Korea’s Ministry of Food and Drug Safety (MFDS) as its new Reference Drug Regulatory...
ARQon
May 2, 20241 min read
Philippines: Regulatory Flexibility Extension for the Unlisted Class B, C, and D Medical Devices in the Registrable Medical Devices List
The Philippines FDA (PFDA) extended the Regulatory Flexibility period further through the issuance of FDA Circular No. 2024-003 on 26...
ARQon
Apr 23, 20241 min read
Malaysia: Directive Overview of Natural Product Registration Based on 'Guideline on Natural Products with Modern Claim' (w.e.f 4 April 2024)
The Drug Control Authorities (PBKD) agreed to register natural products based on the Guideline on Natural Products with Modern Claim,...
ARQon
Apr 16, 20242 min read
Australia: Proposed Revision of Manufacturing Principles for Medicines, Active Pharmaceutical Ingredients, and Sunscreens (w.e.f 3 June 2024)
Australia will be commencing the PIC/S Guide to GMP – 1 February 2022, PE009-16, starting on 3 June 2024, as the manufacturing principles...
ARQon
Apr 9, 20241 min read
Singapore: MOH ACE Implant Subsidy List (ISL) and HTA Process Updates
The Ministry of Health (MOH) of Singapore implementing the Implant Subsidy List effectively from 1 December 2023. The list consists of...
ARQon
Apr 8, 20241 min read
Hong Kong: MDACS Accepts Marketing Approval from Health Sciences Authority (HSA) of Singapore (w.e.f. 2 April 2024)
The Health Sciences Authority (HSA) of Singapore was added to the Medical Device Division (MDD) acceptance list for marketing approval...
ARQon
Apr 3, 20241 min read
India: PSUR Online Submission for Medical Devices/In-Vitro Devices Marketing Authorization (w.e.f 01 April 2024)
The Circular, PSUR-13011(15)/1/2024-eoffice, was circulated by the Central Drugs Standard Control Organization (CDSCO) regarding the...
ARQon
Apr 2, 20241 min read
Singapore: UDI Phase 2 Compliance Date Approaching (w.e.f 1 November 2024)
The Health Sciences Authority (HSA) is reminding all stakeholders, manufacturers, registrants, importers, and wholesalers for the...
ARQon
Mar 27, 20241 min read
Argentina: ANMAT Reviewing Changes to Sales Conditions for Medicinal Specialties (21 March 2024)
Ministry of Health mandated the National Administration of Medicines, Foods, and Medical Technology (ANMAT) through Resolution...
ARQon
Mar 26, 20241 min read
Hong Kong: CP-05 for Listed Medical Devices Distributors by MDD (1 March 2024)
On March 1, 2024, the Medical Device Division (MDD) released the code of practice (CP-05) specifically for the listed medical device...
ARQon
Mar 20, 20242 min read
Taiwan: Essential Insights into Medical Mask Registration Requirements (15 March 2023)
Following the amendment for the Medical Mask (CNS 14774 (T5017)) and Disposable Dust Respirators (CNS 14755 (Z2125)) under the...
ARQon
Mar 19, 20241 min read
UK: New Guidance for Established Medicines Marketing Authorization Application Process Changes (w.e.f 1 March 2024)
Effectively from 1 March 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) released new process changes for the...
ARQon
Mar 14, 20242 min read
Singapore: Final Phase for Transition of the ISO 13485 Certification Granted by SAC-Accredited Body for Medical Device Dealer License Applications (w.e.f 1 January 2025)
Health Sciences Authority issued a reminder about the final transition year for all medical device dealers to obtain confirmation from...
ARQon
Mar 6, 20241 min read
Switzerland: Updated Application Documentation for Medicinal Product Establishment License Discontinuation (w.e.f 9 January 2024)
Generally, companies that intend to manufacture and/or distribute medicinal, transplant, gene therapy products, or genetically modified...
ARQon
Feb 28, 20241 min read
Singapore: Latest Iteration of the Medical Device Product Registration Guidance (GN-15) (w.e.f 24 January 2024)
The Health Sciences Authority (HSA) recently revised the guidance of the medical device product registration (GN-15) under Revision 10...
ARQon
Feb 27, 20241 min read
Philippines: Revision in Application Process for CMDR/CMDN, Initial & Renewal (10 January 2024)
Effectively starting from 10 January 2024, all initial applications for Certificate of Medical Device Registration (CMDR) and renewal...
ARQon
Feb 21, 20241 min read
bottom of page