JNM Global

Global Approval Partner

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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..

Notice of Partial Amendment to the Enforcement Rules of the Medical Device Act

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..

Thailand Cosmetics Regulation Update: Release of Prohibited ingredient list

Thailand has recently implemented changes in the cosmetics regulations, introducing a new list of prohibited ingredients and updating the requirements for permitted preservatives. The latest updates now align Thailand’s regulations with the latest ASEAN Cosmetic Directive revisions. On June 22, 2023, the Ministry of Public Health of Thailand (MOPH) issued three notices through the 140th Governme..

JNM Global/Cosmetic 2023.07.18

The Ministry of Food and Drug Safety’s Plan to Operate the Medical Device Item Renewal System

The purpose of renewing medical device items periodically is to ensure the safety and effectiveness of products. According to the revision of the Medical Device Act, manufacturers and importers must extend the validity period to continue to manufacture and import products after the end of the specified validity period. The Ministry of Food and Drug Safety (Medical Device Safety Evaluation Divisi..