MDCG 2022-5 is a guidance which provides elaboration of the borderline between medical devices and medicinal products, including relevant definitions and examples for these types of products, such as herbal products, substance-based devices and medical device and medicinal product combinations.
More NMPA has made 3 important announcements on issuing the List of Medical Devices Prohibited from Contract Manufacturing (No. 17 of 2022), the Quality Agreements of Contract Manufacturing Medical Devices (No. 20, 2022), and on Matters Concerning the Implementation of the <Measures for the Supervision and Administration of the Production of Medical Devices> and the <Measures for the Supervision and Administration of the Operation of Medical Devices> (No. 18 of 2022), which have been summarized in our article below.
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.
More Japan's Adverse Event Glossary are amended to match with the IMDRF's terminologies.
More 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 The process and duration of the notification scheme for certain class A medical devices compared to the regular class A medical devices registration.
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.
More Previously Japan's PMDA has been accepting MDSAP reports to substitute PMDA's Quality Management System Inspection. However, this move will become official starting April 1st, 2022.
More MDA now recognizes MHRA, UK is now an additional recognized foreign regulatory agency by the MDA and its approval type for Great Britain and Northern Ireland can be used for medical devices to undergo a simplified registration route (by conformity assessment) in Malaysia.
More The Japan Federation of Medical Devices Association (JFMDA) has arranged the Japanese “Adverse Event Glossary” and created a mapping chart to match with IMDRF's Adverse Event terminologies.
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