The European Medical Device Regulations (Regulation 2017/745, MDR) require that each particular device model has its own UDI-DI. Contact lenses vary widely, requiring the manufacturer to specify a number of UDI-DI. The EC adopted this mandate out of concern that a higher number of UDI-DI would lead to a surge in medical device registrations in EUDAMED. The amendment takes effect on November 9, 2..

Medical devices and in vitro diagnostic medical devices in Mexico comply with the Mexico standard NOM-241-SSA1-2021. Mexico is classified into Class I, Class II, and Class III depending on risk, and all medical devices and in vitro diagnostic medical devices must be registered mandatory sanitary registration. The regulatory authorities related to medical devices and in vitro diagnostic medical d..

ANVISA, Brazil's medical device regulator, issued RDC No. 810/2023 to amend Article 60 of RDC No. 751/2022: Declaration and Registration of Medical Devices, the amendment effective August 18, 2023. The revised content allows the import of medical devices and accessories if the manufacturing date is earlier than the date of declaration or registration. Note that the period between the manufacturi..

With the development of information and communication technology, the number of wired and wireless communication medical devices is increasing. As a result, cases of cybersecurity threats such as hacking and information leakage are steadily increasing. For this reason, the application of cybersecurity in medical devices has been strengthened because it can directly harm patient life. Medical dev..

The cosmetics market was sluggish during the pandemic, but is now gradually recovering, showing a positive outlook. Brazil has the world's fourth-largest cosmetics market. In order to enter the Brazilian beauty market, registration of cosmetics with Brazil's ANVISA is essential. Brazilian cosmetics are classified into Class I and Class II according to risk of cosmetics. Classification Descriptio..

The Ministry of Food and Drug Safety has established an integrated guideline for authorization, certification, and examination of wound dressing (a guide to civil petitioners). The wound dressing material is manufactured in various forms, such as item shape, sheet shape, liquid shape, powder shape, etc., and is a medical device used to absorb exudate from wounds, bleed or lose body fluid, and pr..

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..

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..