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5 days ago

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,...

Aug 28

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...

Aug 27

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)...

Aug 21

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...

Aug 20

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...

Aug 14

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...

Aug 13

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...

Aug 7

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...

Aug 6

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...

Aug 1

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...

Jul 30

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...

Jul 24

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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