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Pakistan: DRAP Reminds Manufacturers & Importers to Appoint QPPV/LSO
On 16 August 2023, the Drug Regulatory Authority of Pakistan (DRAP) released a reminder to all Registration Holders, manufacturers, and...

ARQon
Sep 11, 20232 min read


Canada: Health Canada Revised Guidance on Medical Device Establishment Licensing (GUI-0016)
Effectively on the issuance date, 6 September 2023, Health Canada released a few key changes in the guidance on Medical Device...

ARQon
Sep 8, 20233 min read


Malaysia: Decision on the Implementation and Requirements of QMS and Traceability Form
General Registration Technical Committee Meeting by Medical Device Authority (MDA) has made the decision on the requirements of quality...

ARQon
Sep 6, 20231 min read


UK: MHRA Appointed 3 New Approved Bodies for Medical Devices
TÜV SÜD, Intertek, and TÜV Rheinland UK joined in as the latest addition to the UK Approved Bodies announced on 29 August 2023 by the...

ARQon
Sep 5, 20231 min read


China: Implementation of Administrative Measures of Drug Standards (1 January 2024)
Starting from 1 January 2024, the National Medical Products Administration (NMPA) will enforce the implementation of Administrative...

ARQon
Sep 4, 20231 min read


USA: FDA Released Guidance for Enhanced Drug Distribution Security Requirement (27 November 2023)
FDA published guidance to comply with the requirements of the enhanced drug distribution security, under Section 582(g)(1) of the Federal...

ARQon
Sep 1, 20232 min read


China: CMDE Reworks the Medical Device Classification Catalogue
On 15 August 2023, the State Food and Drug Administration under the Centre for Medical Device Evaluation (CMDE) announced the adjustment...

ARQon
Aug 30, 20232 min read


South Africa: SAHPRA Appointed as RCORE for Vaccines Regulatory Oversight
On 25 August 2023, the South African Health Products Regulatory Authority (SAHPRA) was appointed as the Regional Centre of Regulatory...

ARQon
Aug 29, 20231 min read


Australia: TGA Add-on Reporting Requirements for Medicines Shortages in Australia
Prior to the changes of the Therapeutic Goods Act 1989 which was enforced in March 2023, sponsors are required to notify the Therapeutic...

ARQon
Aug 28, 20231 min read


New Zealand:_ Regulation Guidelines Updates of Therapeutic Products (Manufacture of Medicines)
On 16 August 2023, MedSafe released updates on the guidelines of therapeutic products (manufacture of medicines) focusing on the addition...

ARQon
Aug 25, 20231 min read


Finland: _ FIMEA Put-Off Submission of Device Notifications Until Further Notice
Finnish Medicines Agency (Fimea) announced on 2 June 2023, put the submission for device notifications on hold due to the large numbers...

ARQon
Aug 24, 20231 min read


Ukraine: MOH Executes Revised Procedures of Maintaining Register of Responsible Persons
The transitional period for notification submissions of registering medical device information in paper form alongside electronic...

ARQon
Aug 22, 20231 min read


Israel: Implementation Outline of Reformation Plan for Medical Devices by MOH
An implementation plan for the reformation of medical device and equipment registration was released by the Israeli Ministry of Health...

ARQon
Aug 21, 20232 min read


South Korea: Enforcement of Digital Signature Certificates for Cosmetic Companies (16 August 2023)
As of 16 August 2023, the Korea Cosmetic Association (KCA) will begin enforcing the requirement for electronic signature certificates....

ARQon
Aug 18, 20231 min read


Ghana: Additional Requirement for Import Permit Application (Level 2 Code)
Following the expiration deadline of the client registration on ProPer platform, the Food and Drugs Authority (FDA) of Ghana has...

ARQon
Aug 17, 20231 min read


Vietnam: DAV Announces Fee Rates for Pharmaceutical and Cosmetics (1 August 2023)
Effectively from 1 August 2023, the Department of Management Pharmacy will be implementing a new amended standard administrative fee in...

ARQon
Aug 16, 20231 min read


USA: FDA Updates Off-The-Shelf Software Guidance
FDA released updated guidance for off-the-shelf (OTS) software on 11 July 2023, supplanting the previous guidance updated in 2019. Prior...

ARQon
Aug 15, 20231 min read


Italy: Request Methods for Free Sale Certification and GMP Declaration
Requesting Free Sale Certificates and Good Manufacturing Practice Declarations for cosmetics were instructed to be sent via certified...

ARQon
Aug 14, 20231 min read


UK: Guidance of Packaging and Labelling Human Use Medicinal Products (The Windsor Framework)
MHRA released a statement stating that from 1 January 2025, all new medicines in Northern Ireland will be authorized by MHRA and all...

ARQon
Aug 11, 20233 min read


Malaysia: Termination of Stock Level Records Monitoring Activities for Registered Products
Ministry of Health (MOH) stated that as of 15 July 2023, Product Registration Holders (PRH) will no longer be responsible for updating...

ARQon
Aug 10, 20231 min read
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