CFDA has established the Regulations for the Supervision and Management of Medical Devices (People's Republic of China No. 2076) to enhance the safety and health of the people in China for Medical Electrical Equipment manufactured and distributed in China. CFDA certificates are essential for the export and sale of medical devices to China.

CFDA defines medical devices, including instruments, devices, products and materials including the software used alone or in combination, as follows:
- Purpose of prevention, examination, treatment, observation, and mitigation from disease
- Purpose of examination, treatment, observation, mitigation or compensation from an injury
- Inspection, replacement, modification, and conception control for physiology or anatomy
- Pharmacologically for purposes not used in the human body, immunity, metabolism, etc., or for aid, etc.

CFDA's medical electrical equipment registration process is as follows:
1. Classification (www.cfda.gov.cn)
2. Product testing and document evaluation
3. Product registration (if passing test result)
4. Issuance of Certificate

See www.cfda.gov.cn for classification

1. Classification of medical electrical equipment
Medical electrical equipment is classified into Class I, Class II and Class III based on their structure, performance, guidelines and technology depending on the risk of the product.
Class I products are the lowest risk products and Class III is the highest risk product.

2. Test procedure of Medical Electrical Equipment
Product Registration Specification Application (Chinese)
Review product registration specifications
Application for type inspection in China (domestic medical devices / imported medical electrical equipment of Class II, Class III)
Type checking

3. Registration procedure for medical electrical equipment
Registration File Submission (Registration starts when the available test report and clinical test report are complete.)
Document review and evaluation (review of the test report and related documents)
Evaluation and approval from the administration (approval after confirming the application, completed test report and clinical test report according to relevant regulations)
Registration and Issuance of Certificate (Issuance of Medical electrical equipment Registration Certificate, Certificate is valid for 4 years)

When applying for Class II and Class III medical electrical equipment registration, the product must be tested by a CFDA-approved laboratory.