CHINA

NMPA Holds Consultation on Innovative Medical Imaging and AI Devices

The National Medical Products Administration (NMPA) is committed to promoting high-quality development in medical device innovation through regular regulatory consultations. These consultations involve creating specific regulatory plans, guiding registrants to enhance their quality management systems, and ensuring continuous compliance.

Key Points:

1. Innovative Medical Devices Consultation: On July 10, the NMPA held a regulatory consultation for several innovative devices, including a lung gas imaging MRI system, a dual-probe SPECT/CT system, and CT angiography image-assisted detection software for intracranial aneurysms.
2. Integration of Key Information: The consultation incorporated essential information from testing, review, inspection, and monitoring to outline regulatory priorities and quality management key points for registrants.
3. Continuous Quality Supervision: The NMPA has approved 278 innovative medical devices and will continue to focus on quality supervision throughout the product life cycle, ensuring safety and meeting public demand.

Learn more about China Medical Device Registration & Approval.

GERMANY

BrArM (Federal Institute for Drugs and Medical Devices) - Germany

15.07.2024: Application for special approval: Involves instructions published for applying for special approval, indicating a regulatory process or update related to medical device approvals or exemptions.

EUROPEAN UNION

Reporting channels according to MDR , IVDR and MPDG

Involves information on the reporting channels and obligations under the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the Medical Devices Implementation Act (MPDG).

Learn more about EU Medical Device Registration.

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