The specific scope of medical device registration in China includes:

1. Classification: Medical devices are categorized into three classes (Class I, II, III) based on risk levels, with Class I being low-risk and Class III being high-risk.

2. Pre-market Registration: All medical devices must undergo pre-market registration with the NMPA, including submission of product samples, testing data, and manufacturing details.

3. Clinical Evaluation: For higher-risk devices (Class II and III), clinical trials may be required to demonstrate safety and efficacy.

4. Quality Management System: Compliance with ISO 13485 or equivalent standards is mandatory, ensuring consistent quality in manufacturing processes.

5. Labeling and Instructions: Devices must have clear labeling and user instructions that comply with NMPA guidelines.

6. Post-Market Surveillance: Manufacturers are required to conduct ongoing monitoring of device performance and report any adverse events.

This comprehensive registration process ensures that medical devices meet safety and efficacy standards before reaching the market.