CFDA announces classification adjustments and UDI submission guidelines
CFDA have announced two important medical devices regulatory, first about the classification changes, and the second regarding the submission of unique device identifier (UDI) data. Adjustments in classification catalog NMPA has partially revised the Medical Device Classification Catalog, as discussed in Announcement No. 147 of 2020 (link in Chinese). Considerable changes include down-classification of 15 device types […]
USFDA defines Test Plan for Digital Health Software Precertification (Pre-Cert) Program
The FDA is seeking test cases from software organizations planning to submit a De Novo Request or 510(k) submission for software as a medical device (SaMD) in 2019 or shortly thereafter to meet the goals of the Test Plan. The FDA’s request for test case submissions follows the rollout of the Pre-Cert program’s test plan earlier in 2019 establishing processes […]
Guidance on Unique Device Identification (UDI) system in Saudi Arabia
The Saudi Food and Drug Authority (SFDA) has issued guidance on establishing a Unique Device Identification (UDI) system in Saudi Arabia. The guidance covers all medical devices and accessories registered in Saudi Arabia, with the exception of custom-made devices as well as investigational medical devices and IVD devices. The UDI requirements listed by SFDA, generally in line […]
MHLW may extend participation in MDSAP through early 2020
The Japanese Ministry of Health, Labor and Welfare (MHLW) is extending the country’s participation in the Medical Device Single Audit Program through early 2020. According to a recent notification from the Japanese Pharmaceutical and Medical Devices Agency (PMDA), the decision to continue participation means MDSAP certificates will remain valid for Japanese quality management system requirements and audits […]
FDA finalizes Class I classification for some medical device accessories
The US Food and Drug Administration has published a final rule that will go into effect from May 13, 2019, it includes a finalized list of accessories to be designated as low-risk Class I medical devices in accordance with the FDA Reauthorization Act of 2017 (FDARA). FDA have considered an accessory to be eligible for […]
USFDA extends deadline for UDI Compliance for Class II device labelers
US Food and Drug Administration have notified labelers of some Class II devices that the deadline for Unique Device Identification (UDI) compliance has been extended to September 201.8. This extension affects three broad categories of devices, all of which now have a compliance date of September 24, 2018 for UDI labeling as well as Global Unique Device Identification […]
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