National Medical Products Administration (NMPA)
The National Medical Products Administration (NMPA) is responsible for overseeing the safety of drugs, medical devices, and cosmetics, drafting regulatory policies, and promoting new technologies. It also manages standards, regulates registration, and develops Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices.
It also manages post-market risk management, monitors adverse reactions, and handles emergency responses.
The NMPA also manages qualifications for licensed pharmacists, formulates regulations for them, and supervises their registration. It also oversees supervision and inspection of drugs, medical devices, and cosmetics, investigates and punishes illegal activities, and participates in international exchange and cooperation in drug regulation.
The NMPA also guides drug regulatory departments in all provinces, autonomous regions, and municipalities under the Central Government.
http://english.nmpa.gov.cn/index.html
Regulations on the Supervision and Administration of Medical Devices
Class I, II, III
China requires in-country testing for all Class II and III devices, although the NMPA may accept some of the existing testing reports.
Class II & Class III Devices
5 Years
6 Months before expiry
Labelling and descriptions in Chinese
Pharmacovigilance is dedicated to monitoring all adverse reactions associated with drug utilization, encompassing adverse drug reactions (ADRs), defects in product quality, medication errors, and efficacy issues. In China, the pharmacovigilance system comprehensively oversees the entire life cycle of a pharmaceutical product, from pre-approval stages to post-marketing activities.
The strategic integration of pharmacovigilance planning across the entire life cycle of a product aligns with the fundamental principle outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2E guidelines.
Before placing a medical device into the market.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.