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.
More Application audit may be conducted during the procedure of inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG). In some applications, audit may be selective under the legislation, however, others may be selected for an audit at the discretion of the delegate. Here we list out the devices that require mandatory auditing under Regulation 5.3. To conclude, a summarised view of the audit process will be provided.
More In order to further standardize the generic names of medical devices and strengthen the management of the whole life cycle of medical devices, NMPA has organized and formulated six naming guidelines.
More HSA has recently released the “Guidance on the Medical Device Unique Device Identification (UDI) System”. From 2022 in transitioning phases, HSA requires medical devices to be marketed in Singapore to be equipped with UDI-DI.
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In order to ensure the safety and effectiveness of medical devices, the FDA has the Post-Approval Studies Program for 3 kinds of applications. There are Premarket Approval (PMA), Humanitarian Device Exemption (HDE), and Product Development Protocol (PDP). Applicants for these categories should follow the conditions from Post-approval studies to maintain product legality.
More The Center for Devices and Radiological Health (CDRH) has established an internal tracking system for 522 postmarket surveillance studies, where each product applicant can view the status and timeline of their products when the FDA requires the 522 postmarket surveillance study.
More Health Sciences Authority (HSA) – Medical Devices Branch had organized a webinar regarding an introduction to Medical Device Unique Device Identification (UDI) System last October 19, 2020. In addition, the webinar includes the phased implementation plan for UDI in Singapore.
More MDCG has published a guidance for notified bodies on the use of MDASP audit reports in surveillance audit carried out under MDR/IVDR. For those with similar or equivalent requirements, positive QMS conformity result might lead to a reduction of the focus on covered aspect.
More In order to reinforce the supervision and management of the development, production, operation and use of medical devices, NMPA (National Medical Product Administration) has issued the “Draft of UDI Rules for Medical Device” at the end of August with the primary objective of establishing a unique identification system (UDI) for medical devices. This regulation applies to medical devices that are sold and used in China.
More The Unique Device Identification (UDI) system is a set of alphanumeric codes that serves to enhance monitoring activities for medical devices. It consists two parts: (1) UDI (an array of alphanumeric codes) and (2) UDI carrier which come in three distinct types: (a) QR code, (b) Bar code, or (c) RFID/NFC.
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