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..

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..

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..

The Ministry of Food and Drug Safety (Medical Device Policy Division) has prepared some amendments to the Enforcement Rules of the Medical Device Act to improve and compensate for some deficiencies in the operation of the current system, such as preparing grounds for reporting first and second-class medical device supply. Please refer to the link below for details on some amendments to the Enfor..

メキシコの医療機器規制フレームマークは、国際法律及び活動に対する要求事項を合わせるため、最近改定されました。 メキシコ市場の医療機器に対するアップデートされたGMP(Gppd Manufacturing Practice)要求事項は、 2023年6月20日から適用されます。 2021年12月20日に掲示され、2023年6月20日に発行されるメキシコ公式標準NOM-241-SSA1-2021の最新バージョンの医療機器に対する優秀製造慣行（以下NOM-241）は品質、安全及び機能要求事項を遵守するために設計、開発、製造、保管及び流通活動と関連した 医療機器製造業者及び供給網の利害関係者のための最新要求事項を設定しました。 メキシコに位置する医療機器の製造、コンディショニング、保管及び流通（供給網）専用施設は、 すべてこのGMP指針を遵守する必要があります。 最も大きい影響を及ぼしている変更..