Biological testing points
Technical requirements, specifications are equivalent to performance testing. The contracts may be different, it needs to be cleared in advance.
2. Identify biological testing items
The evaluation test is considered according to Appendix A of GB/T 16886.1-2011, the specific contact properties and contact cycles of the product.
The biological testing items shall be determined according to the Appendix A of GB/T 16886.1-2011 standards and the product’s human contact features and cycles.
3. Determine the qualification of testing lab
a) Detection ability: According to the biological testing items, select the competent testing labs to perform the tests;
b) After the testing lab is selected, the manufacturers need to confirm the testing timeline, sample requirements, and testing costs.
4. Test sample preparation
Prepare test samples according to the testing labs requirements for quantity and quality. The batch number of the biological tests samples should be identical to that used for the performance tests.
5. Development of biological testing methods
a) Identify standards or methods for biological testing;
b) Develop the testing solution preparation methods, for example the extraction medium and methods, according to the product’s characteristics.
c) Defining the route of administration for biological testing according to the product’s characteristics. Such as intravenous, oral, or intraperitoneal injection, etc.
6. Test sample delivery
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.
7. Testing process and communication
a) Communication of product technical indicators and methods during the testing process;
b) Active track of the testing process
8. Issue a biological testing report
The testing labs will issue the testing reports according to standardized procedures or procedures offered by the company.
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.