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..

During the festive period, here is the holiday closure dates of the regulatory agencies. Please keep this in mind when working with Africa agencies. PAYS/ AGENCES AGENCIES ANNUAL VACATION BURKINA ( ARCEP) December 11th: National Day (public holiday) December 25th: Christmas (public holiday) January 1st to January 3rd: Closed January 4th, 2024: Resumption TCHAD ( ARCEP) On 28/11/2023: Proclamatio..

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..

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..

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..