On 20 August 2024, the Medical Device Control Division of TFDA released registration guidance for monkeypox (Mpox) diagnostic tests as a...

Under the European Union (EU) Battery Regulation 2023/1542, released last year, all medical device and in-vitro diagnostic device (IVD)...

Compliance effective on 15 June 2024 , prescription lenses for refractive correction are exempted from the requirement for inclusion in...

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...

Annex 1 of the PIC/S Good Manufacturing Practise (GMP) Guide on the manufacture of sterile products has been revised and published. The...

Effectively starting 16 August 2024 , all stakeholders are reminded to note that the number of application submissions into the...

The National Institutes for Food and Drug Control (NIFDC) formulated three new technical documents to facilitate the industry in cosmetic...

The Therapeutic Products Branch (TPB) of the Health Science Authority (HSA) has announced the latest updates on regulatory procedures, as...

Starting on 1 July 2024, the Good Manufacturing Practise (GMP) Standards were implemented in the cosmetics industry, specifically for...

On the 29th of July 2024, the Central Drugs Standard Control Organization (CDSCO) released new circular on the requirement for toxicity...

On the 4th of July 2024, the Department of Health (DH) announced its movement towards the second phase in enhancing the measures of...

After the United Kingdom’s exit from the European Union, the UK and EU established the Windsor Framework, aiming to restore the smooth...

The Therapeutic Goods Administration (TGA) revised the medical device regulations and introduced the amendments on the 26th of June 2024....

On the 2nd of July 2024, the Centre for Medical Device Evaluation (CMDE) announced the clarification by the National Medical Products...

Australia introduces new legislation, The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024, to regulate the...

“NextGen MD Initiative” was introduced by the Health Sciences Authority (HSA) on 13 June 2024 to facilitate the registration of...

The Pharmacy and Poisons Board of Hong Kong (“the Board”) announced that the Refuse-to-File (“RTF”) Mechanism will be enforced in the...

Effective 6 June 2024, the Thailand Food and Drug Administration (TFDA) has executed the new announcement on the registration...

Overall responses from full and thorough jurisdictions based on the current situation in Hong Kong and public consultation led by the...

On the 28th and 30th of May 2024, the Department of Pharmaceuticals of India released 2 Standing Orders regarding the new...