The Malaysian Medical Device Authority (MDA) issued a new guideline document to assist in the registration application of COVID-19 IVD test kits via Medc@st for all previous applications that received Special Access Notification or Conditional Approval and new registration.
More On March 4th, 2022, the Japanese Ministry of Health, Labor and Welfare issued a summary of the Q&A related to the New QMS Ordinance. This notice clears frequent questions and gives related manufacturers/manufacturing authorization holders a more detailed idea on how to be prepared for the new QMS regulation.
More The process and duration of the notification scheme for certain class A medical devices compared to the regular class A medical devices registration.
More NMPA has released a series of updated guidelines, which aim to guide registration applicants to prepare for medical device software and AI medical device registration in China. The 3 new guidelines regulate the technical reviewing requirements of medical device software and AI medical devices, while also elaborating on standardizing the cyber-security for medical devices.
More NMPA has released the latest guidelines, which aim to guide registration applicants in the preparation and writing of passive implantable medical device stability research and registration application materials. While it further also provides a reference for the technical review departments.
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In the last decade, 3D printing has had a profound impact on the medical device sector. When the COVID-19 pandemic hit, this technology was lauded for its ability to adapt new designs and the speed with which it could produce the necessary commodities. Medical 3D-printed gadgets have a bright future, and we will go through the latest advances and how regulatory bodies across the world are keeping up with this development.
More The US Food and Drug Administration (FDA) has updated several regulations affecting De Novo classification of novel medical devices. The main purpose is to present an objective and balance for the scientific evidence to be the foundation to grant a De Novo request. Also, the De Novo products will serve as future predicate devices for prospective 510(k) registration applications to improve and extend the existing 510(k) database.
More Recently, TFDA has announced an update in the Quality Management System (QMS) application required documents for manufacturers in the US, Puerto Rico, or Guam. Considering the establishment inspection timeline, for manufacturers without EIR within 3 years, audit report issued under MDSAP could be provided instead.
More Software as Medical Device (SaMD) is rapidly developing and frequently updating its compatible hardware. In order to ensure the safety, performance, and quality of SaMD while keeping in line with international standards, TFDA has released a guideline regarding post-market change application of SaMD.
More The Medical Device Authority (MDA) produced this new Guidance Document to assist the medical device industry and healthcare practitioners in complying with the Medical Device Act (Act 737) and its regulations.
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