Tag Archives: China

NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software

On January 3, 2019, the National Medical Products Administration (“NMPA”) published a draft standalone software appendix of medical device good manufacturing practice (“Draft Standalone Software GMP” or “Draft Appendix”) for public comment (available here).  Comments are due on January 30, 2019. China revised its medical device GMP in 2014, which apply to all classes of … Continue Reading

Digital Health Checkup (Part Three): Key Questions About AI, Data Privacy, and Cybersecurity

In the third installment of our series, Covington’s global cross-practice Digital Health team considers some additional key questions about Artificial Intelligence (AI), data privacy, and cybersecurity that companies across the life sciences and technology sectors should be asking to address the regulatory and commercial pieces of the complex digital health puzzle. AI, Data Privacy, and Cybersecurity 1. … Continue Reading
LexBlog