On May 27, 2024, the Ministry of Food and Drug Safety (MFDS) posted a revised version of the "Medical Device Adverse Event Report Guidelines" reflecting the revision of the standard code for medical device abnormalities and the frequently used standard code case. The medical device safety information management system is briefly as follows.1. If the medical device handler recognizes that death o..

HAS Medical device product registration applications,  specifically for in vitro diagnostic devices, should be submitted online through MEDICS, utilizing the CSDT or IMDRF IVD MA ToC.In this regard, the Singapore HSA(Health Sciences Authority) issued a directive document on the submission of product registration on March 1, 2024.It details the process for uploading documents related to either th..

On February 22, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) (the COVID-19 Medical Devices Regulations) came into force and created a permanent regulatory framework under Part 1.1 of the MDR for COVID-19 medical devices. Health Canada has expanded the scope of Part 1.1 f..

What is NOM (Norma Oficial Mexicana)? Mexico regulatory standards that manufacturers meet to protect the safety of medical device, IVD, and pharmaceutical users. Mexico COFEPRIS invalidated the standard NOM-137-SSA1-2008 on medical device labeling published in December 2008, and announced an updated new NOM for medical device labeling, NOM-137-SSA1-2024, on April 23, 2024. Updated NOM-137-SSA1-2..

What is customized cosmetics? This refers to cosmetics in which a person with a dispensing manager license divides the contents of cosmetics or mixes the contents of cosmetics with raw materials determined by the Minister of Food and Drug Safety. According to the law below, a list of all raw materials used in customized cosmetics must be reported to the Korea Cosmetics Association by the end of ..

China medical industry is still growing rapidly. As of 2022, the Chinese medical device market was 1.3 trillion yuan, growing 6.1 in size compared to 2013. The Chinese medical device market has a global market share of 27.5%, with an average annual growth rate of more than 12% over the past five years. China is a market that cannot be abandoned despite its policy of using domestic medical device..

Indonesia is the third country to implement the AMDD standard, following Singapore and Malaysia. Indonesia is classified into Class A, Class B, Class C, and Class D according to risk, and product groups are broadly classified into five categories. · Radiation electromedical devices · Non-radiation electromedical devices · Sterile non-electromedical devices · Non-sterile non-electromedical device..

The Cosmetics Regulation Modernization Act (MoCRA) is important to the chapter VI of the Federal Food, Drugs and Cosmetics Act (FDCA) and adds new information (GMP, safety proof, critical adverse event reporting, facility registration, product registration, additional labeling marks, record keeping, etc.). It also gives the FDA the authority to order compulsory recalls. MoCRA's facility registra..

MoCRA（Modernization of Cosmetics regulation Act of 2022）により今年3月からVCRPプログラムが中断されました。 2023年8月7日、FDAは化粧品施設登録及び製品搭載に対する草案を発表しました。 MoCRAによると、既存の化粧品施設及び製品に対する情報は今年の12月29日までに提出する必要があり、2年ごとに更新する必要があるとのことです。 またFDAに施設登録及び製品の搭載に費用は不要となります。 下記の通り施設の登録及び製品の搭載に対する説明をさせていただきます。 １）施設の登録：化粧品の製造業者に対する情報を提出し、FEI（FDA Establoshment Identifier）施設登録番号に管理されます。 ２）製品搭載：製品に対する成分、ラベルに対する情報を提出し、2023年10月から電子提出ポータルを使用することができま..

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. ..