China’s guideline requires that the Class III medical device registration must submit a test report, and the test report should be issued by a certified medical device testing center. The following are the key points that manufacturers should pay attention to when doing the type testing of Class III medical device.
Product performance testing points
1. Preparation of testing documents
a) Product technical requirements (PTR)
- Refer to the performance indicators of similar products on the market;
- The product technical requirements shall be formulated according to national standards, industry standards, and enterprise standards and comply with the Medical Device Product Technical Requirements Guideline issued by CFDA.
b) Instructions and label samples:
- Refer to the instructions and label contents of similar products on the market;
- Prepare according to the Decree No. 6.
c) The testing contract
2. Determine the qualification of the testing center
a) Testing qualification
The manufacturer should check if the testing can be done at certain testing center. The qualification can be determined based on the product type and standards referred in the PTR
b) After confirming the testing center
Once the testing center is determined, the testing timeline and required samples for the testing shall be determined.
3. Sample preparation
- The test sample should be produced and self-tested in compliance with the China GMP requirements.
- Batch number of the test samples must be consistent.
- If the product requires clinical trials, it is recommended that the samples used for type testing and clinical trials are from the same batch.
4. Test sample transportation
a) The manufacturer should send samples according to storage requirements
b) Signing the testing contract with the testing center
It is recommended to communicate with the testing center before signing the contract. Some testing centers need time to review the documents. The manufacturer can send the testing documents first. After the documents are confirmed, the manufacturer can send the testing sample and sign the testing contract.
5. Testing and communication
a) Communication of product technical indicators and methods during the testing process;
b) Active track of the testing process
6. Product technical requirements and pre-evaluation opinions
a) Modify and finalize the product technical requirements;
b) The testing center issues pre-evaluation opinions on product technical requirements.
7. Issue test report
a) Pay all the testing fees after the testing center calculate the expenses;
b) Receiving a registration test report;
c) Return the sample.
Type testing and 3rd party reviews are being encouraged, according to the newly-released Medical Device Amendment.
For more information about medical device type testing, please email info@ChinaMedDevice.com.
About China Med Device, LLC
China Med Device, LLC (https://ChinaMedDevice.com/) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.