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 VCRP program has been suspended since March this year under the Modernization of Cosmetics Regulation Act of 2022. On August 7, 2023, the FDA issues draft guidance for registration and listing of cosmetic product facilities and product Under MoCRA, submission of information about existing cosmetic product facilities and products is required no later than Dec. 29 and Renewal every two years. ..

フィリピン医療機器市場は持続的な成長を遂げています。 医療機器市場に進入するためには、フィリピン食品医薬省（FDA）に必ず医療機器の申告及び登録をする必要があります。 2018-0002（Medical Device Registration Requirements）によると、医療機器はリスクごとに分類され、 その他実施方式及び更新が必要となりました。 フィリピン医療機器はリスクによって4つに分けられています。 Class A – ローリスク (マスク等) Class B – 低い-普通 (診断用医療機器等) Class C – 普通-高い (インプラント等) Class D – ハイリスク (人工心臓等) ​Class Aは申告（Certificate of Medical Deivce Notification (CMDN)) / Class B, C, Dは登録（Certifi..

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..

The UK Government has announced that their product safety laws, which are over 30 years old, are set to be overhauled in a bid to make them modernized. As part of the effort to modernize the regulations, OPSS has opened two new product safety consultations: Smarter regulation: UK product safety review Smarter Regulation: Fire safety of domestic upholstered furniture The consultations will seek v..

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..

General of Foreign Trade of India has issued the Notification No. 23/2023, which amends import policy of items under HSN 8471 of Chapter 84. According to the notification, Import of Laptops, Tablets, All-in-one Personal Computers, and Ultra small form factor Computers and Servers falling under HSN 8471 (hereinafter 8471 products) shall be ‘Restricted’ and their import would be allowed against a ..

On July 26 2023, IMDA announced the planned cessation of Mobile Network Operators’ 3G network and provision of 3G services, with effect from 31 July 2024. With the impending cessation of the 3G network, IMDA will stop accepting new registrations and renewals of 3G-only mobile terminals and non-VoLTE capable mobile/smart phones (hereinafter 3G-only&non-VoLTE products) with effect from 1 November ..

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..

SUBTEL has notified that the authority maintains “Fast Track” procedure in second semester of 2023, which was established in 2022 in order to speed up the response times for the application procedures for equipment certification. “Fast Track” could be requested up to for 5 applications within 6 months per a company. With Fast Track, SUTEL undertakes to expedite and prioritize processing the appl..