China Medical Device Registration
Regulatory Authority
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.
Link for Regulatory Authority
http://english.nmpa.gov.cn/index.html
Local Regulation
Regulations on the Supervision and Administration of Medical Devices
Classification of Medical Devices
1. Class I — low-risk, subject to record-filing (no technical review).
2. Class II — moderate-risk, requires technical review and mandatory testing.
3. Class III — high-risk, requires full technical review, testing, and often clinical trials
Who should make this Communication?
- Manufacturer
- Authorized Representative
When to make this Communication?
Before placing a medical device into the market.
How OMC Medical can assist you with the Process?
Act as your Authorized representative
Why Choose Us?
- Working towards client satisfaction
- Cost effective solutions
- Project completion before deadline
- Quality Regulatory affairs solutions
Ready to Streamline Your Regulatory Compliance?
Join hundreds of companies who trust OMC Medical for their regulatory needs.
