I. Preface
Allogeneic implantable medical devices are products processed or composed of tissues of the same source.
At present, most of the virus screening for tissue donors of allogeneic implanted medical device products in China adopts the method of detecting virus-specific antibodies or antigens in serum. Among them, human immunodeficiency virus (HIV) also requires detection of viral nucleic acids in serum. However, despite rigorous screening of donors, there are still risks of missed detection and unknown virus contamination, as well as the risk of foreign viruses being introduced during production. Therefore, it is required that an allogeneic implantable medical device product adopt an effective virus inactivation process in the production process, and scientifically verify the effectiveness of the virus inactivation process
The guideline is a general requirement for verifying the effectiveness of specific virus inactivation processes during the production of allogeneic implantable medical devices. Applicants/Manufacturer should enrich and refine the content of registration application documents based on the characteristics of specific products, such as the virus inactivation process and related parameters used, and the specific content of the product is determined based on the characteristics of the specific product.
The guideline is a guidance document for applicants/manufacturer and reviewers, but does not include administrative matters involved in registration approval, nor is it enforced as regulations. If there are other methods that can meet the requirements of relevant regulations, they can also be used, but detailed research and verification information shall be provided. The guideline shall be used in compliance with relevant regulations.
The guideline is formulated under the current system of laws and standards and the current level of cognition. With the continuous improvement of laws and standards and the continuous development of science and technology, the relevant content of this guideline will also be adjusted in a timely manner.
