With more and more medical devices containing animal sourced materials, China’s CFDA is strengthening its Technical Guidance for animal derived biomaterials. This is the first revision since 2009.
The technical guidance applies to any medical device which incorporates animal tissue or derivatives, either viable or non-viable.
Specific concerns are potential animal-human pathogen transmission or risks related to immunogenicity. The new draft guidance requests applicants for registration of devices containing animal sourced materials to submit additional information relating to control of these risks, as follows.
- Animal name and species, origin, age, health status, specific tissue used.
- For conventionally raised animal species from a long term supplier (such as cattle, sheep, goats, pigs, horses, chickens, etc), copies of the vendor contract, and the qualification documents of the supplier or dealer.
- For animals from routine slaughter, copy of the agreement between medical device manufacturer and slaughter, and qualification documents of abbatoir.
- Quarantine documents, such as animal quarantine certificates, veterinary certificates for animal vaccination;
- Written undertakings regarding manufacturer’s traceability processes.
- Description of inactivation and virus/pathogen removal steps in the manufacturing process, and relevant validation testing data and reports.
- Description of animal-sourced material’s immunogenicity removal or reduction measure, relevant quality control parameters and validation testing data or reports.
- Risk management reports relating to control measures for pathogen transmission, and immunogenicity.
The guidance will assist the manufacturers of these types of high risk devices with a better understanding as to what the CFDA is expecting to see as part of the device application that contain hazardous materials.
Seeking to supply medical devices in China? We have offices in Beijing and our bilingual regulatory team are expert at CFDA submissions and dossier preparations – including compilation of Clinical Evidence Reports and preconsultation submissions with the agency. Contact us now so we can explain how we can support you in China. Email firstname.lastname@example.org or call Grant Bennett on +61 2 9906 2984 (Sydney) or Steven Wen on + 86 (10) 8532 5809 (Beijing).