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..

On August 29, 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that they had designated three new UK Approved Bodies, almost doubling the UK’s current capacity to certify medical devices. Under the current UK legislation, before a manufacturer can place a UKCA-marked medical device on the market in England, Wales and Scotland, they must secure UKCA marking from a UK..

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 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..

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..

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..

The Philippines medical device market is continuously growing. To enter the medical device market, you must report and register medical devices with the Philippines Food and Drug Administration (FDA). According to the 2018-0002 (Medical Device Registration Requirements), medical devices are classified according to risk, and other procedures and renewals are required. ​ Philippines medical device..