1.Definition of Catalogue of Medical Devices Exempted from Clinical Trials
- For products listed in Catalogue of Medical Devices Exempted from Clinical Trials may be exempted from clinical trials. The Catalogue hereof covers Classes II and III products (including IVD reagents)
2.clinical evaluation data shall be prepared For the products listed in Catalogue
- Contrast data of subject product-related information to the contents described in Catalogue
- Comparison of subject product to the medical devices approved for domestic registration in Catalogue
Notes! Products, in case for the following conditions, cannot be exempted even when their names is in Catalogue
- Products that use new materials, new techniques, new active ingredients, new design or have new mechanism of action and new function
- Products with enlarged or changed scope of application
- Products whose performance indicators fail to meet standards listed in Catalogue
- Other situations that fail to meet clinical exemptions clearly listed in Catalogue
