The National Medical Products Administration (NMPA) of China issued the Regulations on July 8, 2024 to steadily promote the relevant work of high-frequency treatment devices and high-frequency skin treatment devices, and take into account the requirements of public equipment safety and orderly development of the industry. Annex 09-07-02 of the “Notice on Partial Adjustment of the Medical Device ..

Thailand's Food and Drug Administration (TFDA) has issued guidelines on May 9, 2024 for registration of software (SaMD) to determine whether SaMD software is suitable as a medical device. The guidelines for Software as a Medical Device (SaMD) registration are briefly as follows.  Type of medical device software >-       Embedded Software: Software embedded in medical devices-       Standalone So..

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..

Philippine FDA announced FDA Circular No.2024-003 on March 26, 2024. This issuance extended the dates for the application of a CMDN and CMDR for all Class B, C and D medical device that are not included in the list of registrable medical devices based on FC No. 2020-001-A. All Class B, C and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-0..

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..

The Ministry of Food and Drug Safety published ｢Guidelines for evaluating physical and chemical properties of non-absorbable polymer materials for biological safety evaluation of medical devices｣ on April 08, 2024 to help prepare biological evaluation data for medical devices by explaining the requirements, evaluation principles, and processes of data on physical and chemical characteristics ana..

The CMDE under the National Medical Products Administration (NMPA) of China has issued guidelines for registration and review of high-frequency beauty devices (No. 8[2023]). Manufacturers of radio frequency beauty devices classified as Class III will have to comply with the new technical review guidelines from April 1, 2024. The High Frequency beauty device Registration and Review Guidelines (No..

On February 17, 2023, the NMPA in China made an announcement on the implementation of the 3rd Unique Device Identification (UDI) of medical devices. Depending on the degree of risk and regulatory needs, some Class2 medical devices, such as disposable products with high clinical demand, products selected for mass supply, and medical beauty-related products, are determined to be in the third batch..

FDA published a Quality Management System Regulation (QMSR) final rule on February 2, 2024 to revise the current good manufacturing practice (CGMP) requirements for medical devices in the Quality System (QS) Regulation (21 CFR Part 820). FDA amends Part 820 to incorporate the QMS requirements of ISO13485 as references. Replacing the Quality System(QS) with the Quality Management System Regulatio..

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..