Guidelines For Technical Review Of Virus Inactivation Process Verification For Allograft Implanted Medical Devices (2019 Draft For Comments)(Final)

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 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.