On November 7, 2024, the Korean Ministry of Food and Drug Safety (MFDS) issued a partial amendment to the Regulations on the Approval, Notification, and Review of IVDs.  The purpose of the amendment is to reflect minor changes in the Enforcement Rules of the In Vitro Diagnostic Medical Device Act, and to reasonably improve and complement the current system.  This includes expanding the recogniti..

On October 30, 2024, a Q&A was published regarding a gradual roll-out of Eudamed, to obligation to inform in case of interruption or discontinuation of supply, and the transitional provisions for certain in vitro diagnostic medical devices, in connection with Article 10a inserted in (EU) 2024/1860 (amended on June 30, 2024). This Q&A concerns the obligation to notify the discontinuation or inter..

As of October 11, 2024, the Ministry of Food and Drug Safety has registered the revised version of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials). The revised contents of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials) are briefly as follows. 1. R..

On October, 24, 2024, the Office for Product Safety and Standards (OPSS) requested all stakeholders, including the cosmetics industry, academia, consumer associations, and others, to submit scientific information related to the safety assessment of the following cosmetic ingredients:1.     Prostaglandins and prostaglandin analogues2.     Alpha and beta-arbutin3.     Vitamin A All scientific data..

On October 7, 2024, the Thailand Food and Drug Administration (TFDA) announced new guidelines regarding labeling requirements for In Vitro Diagnostic Medical Devices (IVD). These guidelines clarify labeling methods for both home-use and professional-use IVDs, with key points outlined below.  1.   Labeling Requirements for Home-Use- Labels must be affixed in clearly readable Thai and English (pro..

According to the announcement made by the UK OPSS on October 14, 2024, all cosmetics containing the banned ingredient “Lilial” must be discarded, and the recall of products sold after the ban is being considered.  Lilial(Butylphenyl methylpropional), a fragrance ingredient that provides a lily scent, has been used in shampoos, perfumes, and body products, etc. However, it is known to raise safet..

Health Canada (HC) published amendments to certain regulations concerning the disclosure of cosmetic ingredients (SOR/2024-63) on April 24, 2024, which came into effect on October 9.  This includes adjustments to regulatory requirements that may impact all stakeholders in the cosmetic industry, making it essential to review the updated regulations.  The amended regulations strengthen labeling re..

On October 8, 2024, the European Commission’s Medical Device Coordination Group (MDCG) announced guidance MDCG 2024-11 regarding the qualification of in vitro diagnostic medical devices (IVDs). To achieve qualification as an IVD or an accessory, a product must meet the criteria defined in Article 2(2) or Article 2(4) of the IVDR. The MDCG 2024-11 guidance clarifies the scope of products covered ..

The UK Office for Product Safety and Standards (OPSS) has requested the disposal of all cosmetics containing the prohibited ingredient "Lilial" (Butylephenyl methylpropional) on October 14, 2024. This ingredient is known to be harmful to the reproductive system and was added to Annex 2 of the Toys and Cosmetics (Prohibited Substances) Regulations in 2022, prohibiting the sale of products contain..

The Ministry of Food and Drug Safety announced a partial revision of the “Enforcement Regulations of the Medical Device Act” (Prime Minister’s Decree No. 1982) on September 20, 2024. The contents of the Partial Amendment Decree of the “Enforcement Regulations of the Medical Devices Act” (Prime Minister’s Decree No. 1982) are briefly as follows. : Improvement and supplementation of deficiencies i..