This guide has been developed to clarify the approval process for "combination products of medical devices and quasi-drugs" by providing submission requirements, review criteria, and examples for products packaged together. Approval may be applied for as a medical device only when the "primary intended use" of the combination product aligns with that of a medical device. When medical devices and..

On December 16, 2024, the Indonesian Ministry of Health (MoH) issued a regulation (FR.03.01/E.V/2672/2024) classifying Dried Blood Spot (DBS) products as medical devices.  This regulation refers to the classification of DBS as a medical device under the U.S. FDA’s CFR 21 and follows Law No. 17 of 2023 on Health, Article 143, which mandates that the supply of pharmaceuticals, medical devices, and..

The Therapeutic Goods Administration (TGA) of Australia has announced new guidelines (PRAC, Procedure for Recalls, Product Alerts, and Product Corrections) for taking market action to address issues related to therapeutic products that may pose a risk to public health and safety.  Currently, the procedure for taking market actions to address issues with therapeutic products sold in Australia fol..

On December 23, 2024, the Ministry of Food and Drug Safety (MFDS) announced a partial amendment to the Enforcement Rules of the In Vitro Diagnostic Medical Devices Act. The purpose of this amendment is to establish the necessary provisions for implementation in line with the revision of the In Vitro Diagnostic Medical Devices Act, which allows clinical performance testing to be conducted at inst..

The Ministry of Food and Drug Safety Revised the "CGMP Guidelines" as of December 30, 2024The CGMP (Cosmetic Good Manufacturing Practice) is a standard for manufacturing and quality control to ensure the production and supply of high-quality cosmetics. It sets guidelines for the handling and implementation of processes involving personnel, facilities, equipment, raw materials, bulk products, and..

On December 12, 2024, Brazil ANVISA published the updated Cosmetics Classification Rules under Resolution RDC No. 949 (2024).  In Brazil, cosmetics are classified into Grade 1 and Grade 2 products based on their health surveillance level. The classification is outlined in Resolution RDC No. 949 (2024) - Grade 1 products currently total 71 items- Grade 2 products currently total 46 items All prod..

On December 20, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) emphasized the importance of Post-Market Surveillance (PMS) by announcing the final PMS Statutory Instrument (PMS SI) as the Medical Devices (Post-Market Surveillance Requirements) (Amendment) Regulations 2024 (SI 2024 No. 1368). While most of the PMS SI requirements align with EU PMS requirements, new requir..

On December 9, 22024, the Philippines FDA announced Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration under Administrative Order No. 2024-0016.  For the past 20 years, the FDA’s fees and charges were based on Administrative Order No. 50s, 2001. However, due to recent technological advancements and the development of the health products industry, ..

On December 12, 2024, the Ministry of Food and Drug Safety (MFDS) published the 2024 FAQ to help improve understanding of the cosmetics safety management system and support its practical application in various operations.  The FAQ includes answers and explanations to a total of 330 commonly asked questions related to the Cosmetics Act. The document convers a wide range of topics, including:  - D..

On December 11, 2024, the Ministry of Health (MoH) of Indonesia issued a notice (FR.03.01/EV/2653/2024) announcing the temporary closure of the medical device licensing and online certification system for maintenance purposes.  Details regarding the temporary closure of Indonesia’s medical device licensing and certification systems are as follows:  1. Medical device and PKRT Licensing Registrati..