JNM Global

Global Approval Partner

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중국: CCC 승인서 및 마킹 현대화

CNCA는 CCC 승인서 및 마킹 관리에 관한 National Certification and Accreditation Administration Announcement No. 12 of 2023를 발표했습니다. 해당 고시를 통해 CNCA는 전자 승인서 적용을 확대하고 CCC 승인서 및 마킹 관리를 개선하고자 합니다. 고시의 주요 내용은 다음과 같습니다. 1. CCC 승인서의 전자 발급 Ø 신청인이 요구할 경우, 인증 기관은 출력된 승인서를 발급합니다. Ø 기존에 출력되어 발급된 승인서의 유효성은 유지되며, 이후 수정 및 갱신 등을 통해 자연스럽게 전자증명서로 전환됩니다. Ø 출력된 승인서는 전자증명서와 동일한 법적 효력을 갖습니다. 2. 전자 CCC 마크 허용 ① 전자 CCC 마크의 정의 ü 제품에 내..

JNM Korea 2023.08.30

Class II medical device manufacturing (import) licensing procedure

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..

FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products

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 On August 7, 2023, the FDA issues draft guidance for registration and listing of cosmetic product facilities and product Under MoCRA, submission of information about existing cosmetic product facilities and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. ..

JNM Global/Cosmetic 2023.08.23

フィリピンFDA医療機器の登録

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..

Medical device labeling requirements in Korea, USA and Europe

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..