CER (Clinical Evaluation Report) plays a vital role in the clinical pathway in China and predicate-comparison is the key element of CER. NMPA published Guideline on Technical Review on Predicate-Comparison Based Clinical Evaluation of Intravascular Catheters (draft) on October 15, 2020. This will assist and guide manufacturers of such products in the predicate-comparison based clinical evaluation.
The draft guideline specifies that the predicate shall:
- Has obtained the approval in China,
- Has basically the same application scope as the new device, and
- Has similar technical characteristics
The draft document lists the following comparison items to be focused on and gives detailed explanation:
- product basic principles
- structural composition
- production technology and manufacturing materials
- performance requirements
- application scope
- methods of use
- precautions and warnings
- indication for use
It also provides eight mandatory standards and seven situations on intravascular catheters including:
- Different retention time
- Coated and uncoated
- Different main raw materials
For the English version of the Guideline on Technical Review on Predicate-Comparison Based Clinical Evaluation of Intravascular Catheters (draft), please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
“Intravascular Catheter” in this guideline refers to the partial or entire insert or implanted cardiovascular system, which is a tubular instrument with one or more cavities that is used to establish a pathway between blood vessels and external fluids or other substances. Such as the central venous catheter (CVC), peripherally inserted central catheter (PICC), peripheral venous catheter (PVC), etc.
Predicates in China shall be the products with: 1) NMPA approval; 2) Equivalent scope of application; and 3) Equivalent technical characteristics.
Clinical Pathway in China
Generally, there are four clinical pathways:
- Clinical Trial
- Overseas Clinical Data
- HaiNan Real World Data
In China, most of the intravascular catheter products are Class III medical devices that are not exempted from clinical trial. However, with this guideline, clinical trial can be avoided for most of the intravascular catheters with predicates in their China entry and this will save the manufacturers great amount of money and time.
Different from CER requirements from other countries, PREDICATE is an essential element on the CER compilation. Here is a general comparison between China and EU CER.
China Med Device (Email: email@example.com) can help you determine the product classification, assess your predicate qualification and compile a qualified CER.
NMPA (CMDE) is now collecting information online from the public. If you are manufacturing any of the products above or you have any opinion in this guideline, you are all welcome to fill the information collection form. You can email (info@ChinaMedDevice.com) for the form. Do not miss your chance to provide your opinions and comments about the guideline during the NMPA preparation phase.
The submission deadline is November 15, 2020. For more information about how this process work, please contact China Med Device (Email: firstname.lastname@example.org). We can also help you prepare and submit the feedback directly.