Hong Kong MDD, Updated the Guidance (GN-01) on Renewal Application for Listing Medical Device

The Hong Kong Medical Device Division (MDD) has implemented the Medical Device Administrative Control System (MDACS) to regulate medical devices, including operating a device registration system and an adverse event reporting system.  On September 30, 2024, the MDD updated Sections 5.14 and 5.15 in the Guidance (GN-01) on the Overview of the Medical Device Administrative Control System (MDACS), ..

China NMPA, Updates Safety and Technical Standards for Cosmetics (2015)

On October 30, 2024, the National Medical Products Administration (NMPA) of China updated the Safety and Technical Standards for Cosmetics (2015). The update includes the addition of five testing methods, one of which is for the “Test Methods for Azelaic Acid and its Salts in cosmetics”These new and revised standards are now incorporated into the 2015 edition of the Safety and Technical Standard..

When a holder of a manufacturing or import license for a medical device wishes to transfer the license to another company, the transfer of the license may be required.  The Thai Food and Drug Administration (TFDA) updated the guidelines for the transfer of medical device licenses for manufacturer and importers on September 19, 2024.  For medical devices that do not require expert review for appr..

On September 24, 2024, the Thai FDA updated its cosmetics advertising guidelines to provide oversight and regulatory direction for cosmetics advertising management, in accordance with the 2015 Cosmetics Act.  The 2024 revised guidelines comprehensively cover topics related to cosmetics advertising, including the definition of cosmetics advertisements, relevant advertising laws, principles for co..

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..

PMDA (Pharmaceutical and Medical Device Agency) is a comprehensive pharmaceutical and medical device organization that aims to contribute to improving national health by guiding and examining the quality, efficacy, and safety of pharmaceuticals and medical devices, and collecting, analyzing, and providing information on safety after marketing. Japan's medical device classification system is base..

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..