With the implementation of the revised Medical Device Management Enforcement Decree (98/2021/ND-CP) in 2021, Vietnam (MoH) extended the registration expiration date for Class C and D medical devices by one year to December 31, 2022, and made distribution registration mandatory from 2022. However, during that period, companies experienced a lot of inconvenience and confusion as the Ministry of He..

The Hong Kong Medical Device Division (MDD) has announced that the “Essential Principles of Medical Device Safety and Performance” (Technical Reference: TR-004) will be available for use in the Medical Device Administrative Control System (MDACS) from 1 January 2024. Hong Kong's existing reference countries were Australia, Canada, the European Union, Japan, and the United States, but as the info..

MDSAP is a certification system created by five regular member countries, the United States, Japan, Canada, Australia, and Brazil, for the purpose of joint review according to international standards for medical device safety and quality control. From December 19, 2023, the Ministry of Food and Drug Safety revised part of the Medical Device Manufacturing and Quality Control Standards to improve ..

According to the law below, Responsible sellers are required to report the 2023 cosmetics production performance to the Korea Cosmetic Association from January 1, 2024 to February 29, 2024. • 「Cosmetics Act」 Article 5 / Article 4 (Duty of business operator, etc.) • 「Cosmetics Act Enforcement Rules」 Article 13 (Report on production performance of cosmetics, etc.) • 「Regulations on the production ..

The Hong Kong Medical Device Administrative Control System (MDACS) has published a new technical reference document (TR-007) related to software medical devices (SaMD and SiMD) on December 29, 2023. Technical Reference TR-007 covers SiMD and SaMD risk management requirements and basic cybersecurity requirements. The software medical device technical documentation requirements for MDACS applicati..

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 ..

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..

AVNISA, Brazil's medical device regulator, updated IVD regulations to RDC 830/2023. The new RDC, effective from June 1, 2024, is a comprehensive revision that consolidates risk classifications and regularization procedures across all IVD risk classes, rendering the previous RDC 36/2015 obsolete. The main changes are as follows. - Provide process (notification and registration), ANVISA forms to p..