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..

It has obligations such as record keeping, reporting and handling of products through the following four corporations designated as Economic Operators under the European Medical Device Regulations (EU MDR). Manufacturers Importers Distributors Authorized representatives However, manufacturers that are not located in the EU require authorized representatives. As such, MDCG 2019-5 rev.1 outlines t..

The label of the medical device should be marked on the container, exterior, or external packaging. It should be in a location where consumers can easily find it, and should not fall off easily. Medical device labels are mandatory, and each country has its own obligations. We will briefly explain the labeling requirements in Korea, the US and Europe. 1. Korea (1) Trade name and address of manufa..

Medical device quality system certification is called Good Manufacturing Practice (GMP). GMP certification, commonly referred to as ISO 13485 certification, is a process managed by a medical device manufacturer over the life cycle of the medical device, from the development of the device to the post-production stage, including disposal. There are many countries that can be licensed with ISO 1348..