SASO has notified the draft decision as regards the unification of chargers’ type for smart phones and electronic devices to be USB Type-C as a minimum for all products of radio and information technology equipment under the scope of the decision. The produces covered by the notification is as follows: The draft decision to introduce a common charging solution for the products of Radio & Informa..

In Australia, sunscreens are classified as primary sunscreens or secondary sunscreens according to the SPF. Sortation Sortation Regulatory body Primary sunscreens Products with SFP of 4 or higher whose main purpose is to protect against UV Categorized as Theraputic Goods - TGA regulation: Must be listed in ARTG. Secondary sunscreens (Products regulated by TGA) Products that have main purposes ot..

To enter the Thai beauty market, it is essential to register cosmetics with the Thai FDA. Thai cosmetics are regulated under Cosmetics Act BB.E 2558(2015). Also, Thai cosmetics are regulated by ASEAN Cosmetic Directive(ACD) under the guidelines of ASEAN Cosmetic Committee(ACC). When registering cosmetics, PIF and label are basically required. - Material safety data sheet (MFDS) - GMP or ISO of m..

Taiwan Medical Device Registration is managed by the Food and Drug Administration (TFDA). First, in Taiwan, classification of general medical devices is classified into Class I, II, and III according to the FDA rating system in the United States, and is classified into 16 items below. No. Item name 1 Clinical chemistry and clinical toxicology 2 Hematology and pathology devices 3 Immunology and m..

SIRIM has issued Announcement No. SQASI/CMCS/1/23/0006, which updates the arrangement of services operation by CMCS, in light of the improved situation regarding the COVID-19 pandemic and the subsequent lifting of lockdown measures. According to the announcement, the following announcements published during the pandemic became invalid: SQASI/CMCS/1/20/0004 EXTENSION OF MOVEMENT CONTROL ORDER (MC..

CNCA has issued the National Certification and Accreditation Administration Announcement No. 12 of 2023, on Compulsory Product Certification Certificate (hereinafter as CCC Certificate) and Marking Management. With the announcement, CNCA expands the application of electronic certificates and improves the management of CCC Certificate and Marking. The summary of the announcement is as follows: CC..

On August 18, 2023, ENACOM has published Resolution 1132/2023 in the Official Bulletin of Argentina, which approves new versions of two standards – ENACOM-Q2-63.02 V23.1 “Equipment Integrating Systems of Broadband Digital Modulation” & ENACOM-Q2-63.03 V23.1 “Equipment Integrating Systems of Frequency Hopping”. The main changes are as follows: The Resolution gives 90 days from its publication in ..

First of all, second-class medical devices are largely divided into four categories: the same product, equivalent announcement product, clinical trial-free product (certification), and clinical trial-required product (license). The screening process varies depending on the classification, so I explain it as below. Therefore, manufacturers (importers) must follow the necessary processes below, de..

According to 2022 medical device industry production and import/export statistics, It is an infectious disease diagnostic test reagent that ranked 1st in domestic production and export and accounted for 48.4% of exports. Diagnostic reagents are mainly used in in vitro diagnostic devices. In other words, the field of in vitro diagnostic devices, which has grown rapidly due to COVID-19, is expecte..

The class 1 application of medical devices is the most applicated class because it is a simple procedure compared to the certification and authorization procedures. The products that have recently been reported a lot with the first grade are as follows, and we will inform you of the brief reporting process and necessary documents. 등급 분류번호 품목명 1 A59060.01 a manual cervical extensor A01060.02 elec..