Clinical trial approval for Class III medical device with higher risk

Base on the《Administrative Measures for Medical Device Registration》, The clinical trials for Class III medical device with higher risk to human body should be approved by CFDA. CFDA has issued the《Catalogue of Medical Devices need to be approved prior to Clinical Trial》, and will adjust the catalogue at regular intervals.

The following table is the latest《Catalogue of Medical Devices need to be approved prior to Clinical Trial》

 
Catalogue of Medical Devices need to be approved prior to Clinical Trial
ID Code Scope of Product
1 6821 Implantable pacemaker or defibrillator
2 6845 Implantable blood pump
3 6854 Implantable drug infusion system
4 6846 Endovascular stent system not yet placed on the domestic market
5 6846 Implantable artificial organs, contacting artificial organs and orthopedics fixed or filled material, which not yet placed on the domestic market
6 6846 Absorbable fixation products used in the long bones of limbs
7 6846 Nanometer orthopedics implants
8 6846 Orthopedics implants produced with tailored material (3D printing)

If your product belongs to the catalogue, you should fill in and submit the《Application Form of Clinical Trail Approval for Medical Device(Download)and other application document to CFDA. CFDA will make a comprehensive analysis for clinical trials risk degree, clinical trials protocol, contrastive analysis of clinical benefits and risk, and so on, to determine whether the clinical trials can be conducted in according with the application document.

CFDA will issue medical device clinical trials approval if clinical trials are permitted, or give a written reason for refusing approval. The approved clinical trials should be carried out within 3 years after receiving clinical trials approval, otherwise the clinical trials approval document will be abolished automatically.

CFDA will repeal achieved clinical trials approval if the following circumstances happen:

 
  1. Application materials of clinical trials is mendacious.
  2. There are proofs which can certificate original clinical trials is problematic in ethicality and scientificity.
  3. Other circumstances.


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