FDA update: ASCA Becomes a Permanent Program

Effective September 19, 2023, the U.S. Food and Drug Administration’s ASCA Program is converting from a pilot to a permanent program. This transition is authorized by the Medical Device User Fee Amendments of 2022 (MDUFA V). The ASCA program will continue to be implemented through the final guidance documents.

A device manufacturer may choose to use an ASCA-accredited testing laboratory to conduct testing for premarket submissions to the FDA. For such testing, ASCA-accredited testing laboratories provide the device manufacturer with all the information listed in the relevant ASCA program specifications. When the device manufacturer includes a declaration of conformity with an ASCA Summary Test Report as part of their premarket submission, the FDA will have confidence in the testing laboratories’ test methods and results and does not intend to request additional information regarding testing methodologies.



New Q&A for MDR/IVDR Extension

EU just published a new Q&A sheet to address the extension of the MDR and IVDR deadline.



Taiwan - UDI labelling will turn mandatory for class II devices

In Taiwan, starting from June 1, 2023, license holders of Class II medical devices are required to upload UDI and corresponding product information to the UDI Database (UDID). Class II medical device manufacturers are also required to place UDI on the product label.

China NMPA has published a new arrangement for pre-registration technical consultation services for domestic class III medical device.

Please visit the link for the Chinese notification. 关于医疗器械受理前技术问题咨询工作安排调整的通告(2022年第37号) (cmde.org.cn)

Taiwan TFDA has updated the Medical Software Classification Guidance with more solid examples.

For the English translated ordinance, please refer to the attached pdf.

The HK Department of Health has introduced a pilot run on medical device procurement by giving preference to device listed under the MDACS.

For details of the pilot run, please refer to the attached ppt.