Anwendungsbereich des Regulatory Essentials
Geltende Rechtsvorschriften:
Article 2) These Regulations are applicable to the research, development, production, operation, use and supervision and management of medical devices within the territory of the People's Republic of China.
"Medical devices" refer to instruments, equipment, utensils, in vitro diagnostic reagents and calibrators, materials, and other similar or related items that are used directly or indirectly on the human body, including required computer software.
Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents
Article 2 - These Measures apply to the registration, filing and supervision and management of in vitro diagnostic reagents within the territory of the People's Republic of China.
Article 3 - The in vitro diagnostic reagents mentioned in these Measures refer to the in vitro diagnostic reagents managed as medical devices, including those used in vitro for human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation. Reagents, kits, calibrators, quality control products and other products for detection can be used alone or in combination with instruments, appliances, equipment or systems.
The in-vitro diagnostic reagents used for blood source screening and the in-vitro diagnostic reagents labeled with radionuclides that are managed according to drugs do not fall within the scope of management of these measures.
Nationale Anwendungsebene:
People's Republic of China, IVD Class I,II,III; NMPA, CMDE, Electronic Registration, UDI Regulation
Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung:
Not comparable with the EU IVD Regulation, especially because of different classification conditions of medical and IVD products....