Medical device companies have many difficulties entering the market due to the cost and time required to obtain certification, the creation of enhanced technical documents, and the lack of information on essential regulations by country. Various organizations are carrying out many support projects to solve these difficulties, minimize the burden of certification barriers, and help them enter the..

U-Healthcare Medical Device? Based on wired and wireless communication infrastructure, It is a medical device that enables medical personnel to remotely monitor patients' biological signals measured in real time in non-medical places, manage their health, and provide appropriate health care services in a timely manner. Recently, the Ministry of Food and Drug Safety published guidelines for quali..

In order to receive MFDS ClassII certification, technical document review by technical document review agency is essential. Currently, the fee for reviewing technical documents for second-class medical devices has been frozen for 13 years, resulting in a vicious cycle of worsening management of review institution, delayed complaint processing periods, and deterioration of civil service. To refle..

Hong Kong Medical Device Division (MDD) issued formal guidance (GN-10 Guidance Notes on Changes for Listed Medical Devices) on the requirements to maintain compliance when making changes to a medical device registered with the Medical Device Administrative Control System (MDACS). The GN-10 guidelines include classification of whether changes to registered medical devices are major or minor and m..

From November 17, 2023, it has been partially revised to clarify administrative procedures by preparing standards and procedures for lifting the designation of medical devices subject to follow-up management and to match the name of the medical device subject to follow-up management with the item name specified in the Regulations on Medical Device Items and Classes by Item. The major revisions a..

Based on the results of the risk assessment, the Ministry of Food and Drug Safety announced some revisions, such as adding some ingredients of hair dye to the list of raw materials that cannot be used in cosmetics and adding a chemical substance identification number (CAS No.) such as raw materials that cannot be used in cosmetics to increase the convenience of identifying raw materials. Please ..

India CDSCO introduced the Medical Device Rules (Medical Device Rules, 2017), Items subject to medical device registration have been expanded, and online applications for medical devices (SUGAM) have become mandatory. In order to enter the Indian medical device market, it is essential to check whether registration is required and the product risk level through the classification table. According..

The U.S. FDA was scheduled to open a platform in October to register and list cosmetics facilities required by the U.S. Cosmetics Regulatory Modernization Act (MoCRA). Therefore, the existing products sold had to be listed by December 29, 2023. However, there were many opinions from global companies and related organizations that they needed time to prepare for regulatory response. The FDA accep..

The European Medical Device Management System has been upgraded from Directive MDD(Directive 93/42/EEC for Medical device) to Regulation MDR(Medical Device Regulation (EU) 2017/745). With the introduction of higher regulation MDR, Companies that have undertaken the work of certification bodies with existing MDD NBs should be re-evaluated by enhanced European authorities on NBs' designation crite..

TEC has recently released an official update (amendment of notification no. 5-2/2021-TC/TEC/165 dated June 23, 2023) regarding the testing and certification of telecommunication equipment under the Phase V of the MTCTE regime. 1. Mandatory Certification Date The mandatory certification process under Phase V of the MTCTE regime will start from July 1, 2024. However, those interested can start app..