Vietnam IMDA, Notice on Changes to Medical Device Registration Fees

On July 2, 2025, the Ministry of Health (MoH) of Vietnam announced that medical device registration fees will be reduced to 50% of the original fees for the period from July 1, 2025, to December 31, 2026. The reduced registration fees for medical devices are as follows. ClassificationOriginal fee50% Discounted fee (2025.07.01 ~ 2026.12.31)Class A1,000,000 VND500,000 VNDClass B3,000,000 VND1,500,..

EU CPNP, Update of the glossary of common cosmetic ingredient names for labeling

On June, 16, 2025, the European Commission (EU) announced implementing decision (EU) 2025/1175, which updates the glossary of common ingredient names used in cosmetic labeling to reflect to newly adopted ingredient names for cosmetic products placed on the EU market. This amendment includes a total of 30,149 entries, will enter into force on July 30, 2025, and will be fully applicable from July..

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..

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 ..