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China to Exempt Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials

On Sept. 18, the National Medical Products Administration (NMPA) released the List of Medical Devices Exempted from Clinical Evaluation and the List of In Vitro Diagnostic Reagents Exempted from Clinical Evaluation. Both are scheduled to take effect on Oct. 1, 2021.

On Sept. 18, the National Medical Products Administration (NMPA) released the List of Medical Devices Exempted from Clinical Evaluation1 and the List of In Vitro Diagnostic Reagents Exempted from Clinical Evaluation2. Both are scheduled to take effect on Oct. 1, 2021.

The former list covers 1,010 categories of Class II/Class III medical devices; the latter contains 423 categories of Class II/Class III IVD reagents. The categories are listed with names, functions and registration/filing classes. The lists make it easier for applicants to check whether their products fit into the categories.

Definition of Clinical Evaluation for Medical Devices/IVD Reagents in China

Definition of Clinical Evaluation for Medical Devices/IVD Reagents in China

Clinical Evaluation for Medical Device

Clinical Evaluation for IVD Reagent

Activities using scientific and reasonable methods to analyze and evaluate clinical data, and finally to confirm the safety and effectiveness of the medical device in its application scope.

Process using scientific and reasonable methods to analyze and evaluate clinical data to verify whether the IVD reagent product meets the needs for use or achieves the expected functions, and finally to prove the safety and effectiveness of the product.

References: Administrative Measures for Medical Device Registration and Filing3and Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing4

Clinical Evaluation/Trial Exemption Conditions and Corresponding Submission Requirements

The two lists deserve stakeholders' attention because applicants can spare themselves from conducting clinical evaluation/trials if their products are eligible for exemption:

Clinical Evaluation/Trial to be Exempted from Eligible Medical Devices and IVD Reagents in China


Medical Device

IVD Reagent

Exemption

Clinical Evaluation Exemption

Clinical Trial Exemption

Registration/filing applicants can skip clinical evaluation only when the medical device meets one of the following conditions:

(1) The medical device has a clear work mechanism and a fixed design, and is produced with mature technologies. There is a same type of previously approved product that has been clinically used for years with no record of severe adverse events. Also, the new medical device's functions are kept the same as the normal ones of this type of medical devices.

(2) There are other methods to prove that the new medical device is safe and effective.

Registration/filing applicants can skip clinical trials only when the IVD reagent meets both of the following conditions:

(1) The IVD reagent has a clear work mechanism and a fixed design, and is produced with mature technologies. There is a same type of previously approved product that has been clinically used for years with no record of severe adverse events. Also, the new IVD reagent's functions are kept the same as the normal ones of this type of IVD reagents.

(2) The new IVD reagents can be proved to be safe and effective by methodological comparison with the same type of products.

Submission

For medical devices meeting the condition(s), clinical evaluation documents are not required for the submission.

For IVD reagents meeting the conditions, clinical trial evaluation documents are still required for the submission.

Necessary documents include the analysis of the comparison between the new IVD product and the same type of approved product, data of methodological comparison, the analysis of relevant literature and data, the analysis of empirical data, etc.

References: Administrative Measures for Medical Device Registration and Filing;  

Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing

For more details of the two lists or medical device/IVD reagent registration/filing procedures, welcome to contact us via contact@chemlinked.com.

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