Singapore HSA, GN-21 Revision: Guidelines for Change Notification of Registered Medical Devices

In July 2025, the Health Sciences Authority (HSA) of Singapore revised GN-21: Guidelines for Change Notification of Registered Medical Devices. This guideline is designed to help determine whether a Change Notification should be submitted for medical devices registered in the Singapore Medical Device Register (SMDR). According to the Health Product (Medical Devices) Regulations 2010, any changes..

Vietnam DAV, Amendment to the Cosmetic Management Regulation

On Jully 3, 2025, the Vietnamese Drug Administration (DAV) issued Circular 34/2025/TT-BYT, amending certain provisions of Circular 06/2011/TT-BYT The main amendments to the regulation are as follows: 1) Online submission and electronic signatures can be used during the submission process. 2) Ingredients must be listed accurately according to the INCI. Chemical names and botanical names must also..

The Therapeutic Goods Administration (TGA) of Australia has strengthened post-market surveillance measures for medical devices to better identify and manage safety issues, enabling swift responses whenever problems are detected. The key initiatives for monitoring adverse events related to medical devices include the following. 1) Medical device companies: Enhanced reporting mechanisms are being..

On June 16, 2025, the European Commission (EC) revised the Glossary of common ingredient names used in cosmetics labeling. This revision reflects the new ingredient names currently in use for cosmetics placed on the EU market. The key amendments are as follows.1) New INCI names, published by the Personal Care Product Council, have been adopted, and corrections have been made to existing ingredi..

The Therapeutic Goods Administration (TGA) charges fees for services such as product evaluations and activities involving Australian sponsors. In addition, an annual charge, which is a type of tax applied to the regulated industry, is imposed based on the financial year running from 1 July to 30 June each year. According to the Australian financial year, from 1 July 2025, the following annual c..

On June 19, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced a partial amendment to the Enforcement Decree and Enforcement Rule of the Cosmetics Act. This amendment aims to establish matters delegated by the Act in relation to Cosmetics Day and the investigation of the current status of directly purchased foreign cosmetics. Following the amendment to the Cosmetics Act (effect..

On June 5, 2025, the medical device Authority (MDA) of Malaysia announced a revised regulatory approach regarding the use of expired EC certificates for the purpose of new medical device registration in Malaysia. CE Marking (EC Certificate) issued under EU Directives 90/385/EEC, 93/42/EEC, and 98/79/EC continues to be recognized by the MDA as a valid form of approval for conformity assessment in..

In June 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced the publication of the following two guidelines concerning alternative animal testing methods for cosmetic product safety- Guideline on In vitro skin sensitization assay (EpiSens A) for cosmetics and related products- Guideline on Ocular irritation test method using reconstructed human cornea-like epithelium (RhCE) for ..

On February 19, 2024, China’s National Medical Products Administration (NMPA) announced five new test methods for cosmetic ingredients, including the method for azelaic acid and its salts. These methods will be officially incorporated into the Technical Guidelines for Cosmetic Safety (2015 Edition) and will take effect starting July 1, 2025. The test methods to be included in the 2015 Edition of..

On May 21, 2025, Singapore’s Health Sciences Authority (HSA) announced that it will replace the current medical device registration submission system, MEDICS, with a new one-stop digital portal for regulatory services, SHARE, starting July 14, 2025. This system transition will affect all ongoing and upcoming registration applications for medical devices. To ensure a smooth transition, stakeholde..