The FDA has issued a draft guidance to clarify how it reviews real-world data, ensuring its quality for generating evidence that can inform regulatory decisions on medical devices.
More The US FDA issued a draft guidance for medical devices that have relation to Weight Loss. The purpose of this guidance is to provides recommendations for both clinical and non-clinical testing to support premarket submissions.
More PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.
More The NMPA drafted the <Announcement on the Third Batch of Implementation of the UDI of Medical Devices (Draft for Comment)> and is now soliciting opinions publicly.
More An official letter number 6698/BYT-TB-CT was released on November 21, 2022, by the Vietnam Ministry of Health, collecting comments for a draft decree amendment of decree 98/2021/ND-CP
More PFDA held a public hearing about updated draft for the In-vitro diagnostic (IVD) medical device regulation and registration in the Philippines including discussion on transition period and implementation timeline.
More Utilization of Remote Regulatory Assessments (RRA) as a critical examination of an FDA-regulated establishment and/or its records. FDA has published the draft guidance to let more people understand its value and what FDA expectations for RRA are.
More HSA Medical Devices Cluster (MDC) shared a draft guideline for the regulation of Laboratory Developed Tests (LDTs). The regulation’s scope includes laboratories that develop In Vitro Diagnostic (IVD) devices. HSA requests stakeholders to provide comments for further discussion.
More PFDA released a draft circular that provides the requirements for good storage and distribution practices for medical devices, to serve as guidelines for medical device establishments in the Philippines.
More PFDA extended the CMDN Requirement of Class B-D Non-Registrable products until March 2023. This will allow continue selling of the affected products in the country using a License to Operate as the requirement. In addition, PFDA shared draft regulations pertaining to the earlier released Abridged Route Evaluation and COVID-19 products using new technologies.
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