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..

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..

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..

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 Central Drugs Standard Control Organisation (CDSCO) of India has issued a notice on October 25, 2023, updating several in-vitro diagnostic (IVD) classifications. These updates mean that all medical devices, regardless of class, must either be registered in India through the ePortal or receive an MD-15 import license before importing. The updated IVD classification is as follows. - Annex A fo..

Medical devices sold in Brazil must be manufactured by a manufacturer with a Quality Management System (QMS) that complies with the Brazilian Standards of Good Manufacturing Control (BGMP) (RDC 665/2022 and RDC 497/2021). In Brazil, Class III and Class IV manufacturers are required to obtain a BGMP certificate, which is valid for two years. ANVISA uses a risk-based approach (RDC 217/2018 and RDC..