There is no specific definition in the People’s Republic of China regulatory framework clarifying the term “digital health,” but there is general acceptance that the term refers to digital technologies applied across the healthcare sector. 1,2 This article describes recent updates to the regulatory framework for digital health applications that qualify as medical devices under China’s regulations.   Keywords – China, digital health, regulatory   Introduction...

Feature articles in June examined food safety in China, US Food and Drug Administration (FDA) guidance on supply chain disruptions, possible updates to the US Dietary Supplement Health and Education Act (DSHEA), and FDA and Federal Trade Commission (FTC) regulation of dietary supplements intended for treating or preventing certain mental health disorders.   Safety, disruptions, and responsive policy  China has improved its overall food safety situation significant...

This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formula, health foods (functional foods), and food for special medical purposes (FSMP). Keywords – infant formula; food for special medical purposes; food regulatory control; food safety; food standards   Introduction Since the m...

An official with the US Food and Drug Administration (FDA) announced the agency will soon resume unannounced onsite inspections in India and China. Also, prioritized foreign inspections will resume in February.   Elizabeth Miller, assistant commissioner for medical products and tobacco operations in FDA’s Office of Regulatory Affairs (ORA), provided this update on the agency’s inspection activities at a 9 December virtual conference on enforcement sponsored by the Fo...

This article reviews Chinese laws governing healthcare data and genomic resources during 1998-2021 and their impact on clinical research in humans by pharmaceutical companies. Companies conducting such research must be vigilant about complying with the complex legal requirements governing the research and identifying potential risks and mitigation strategies for compliance. The analysis includes review of various legal requirements issued by the People’s Republic of China ...

This article outlines the status of regulation for software as medical device (SaMD) in China, with particular focus on medical software using artificial intelligence (AI) technology. The market approval pathways are reviewed, and key sticking points discussed. Recent regulatory updates in this fast-moving area are presented, together with various product approval examples.   China’s medical software regulatory framework The term “medical device” is defined widely ...

The Vietnamese health ministry has met with the World Health Organization (WHO) to discuss the transfer of the technology needed to manufacture mRNA vaccines in the country.   Vietnam received a shipment of 811,200 doses of the COVID-19 vaccine developed by AstraZeneca and the University of Oxford via the COVAX Facility at the start of last month. Around 900,000 people have now received a vaccine, but the supply of doses remains a constraint on the pace of the rollou...

Welcome to the inaugural issue of RF Quarterly featuring original, thematically developed content by regulatory experts addressing key areas and emerging issues in the global regulatory landscape. RF Quarterly is a member-exclusive addition to the regular monthly  Regulatory Focus  feature articles and replaces the former quarterly article series. The theme for this issue is Global Clinical Trials.   Clinical trials are an essential component of pharmaceutical re...

This article discusses numerous recent changes in the regulation of clinical trials in China and proposes that Chinese clinical trials for medical device and in vitro diagnostic device (IVD) products are an increasingly viable option for non-Chinese companies of all sizes. [Updated]*   China’s regulatory framework Most life sciences products, including medical devices and IVDs, sold in China are supervised by the National Medical Products Administration (NMPA).  The ...

Feature articles during February included a range of topics focused on harmonization and alignment across global and regional regulatory entities, including electronic submissions through the European Medicines Agency (EMA), tools for updating the EU In Vitro Diagnostic Regulation (EU IVDR) template, China’s new PAC regulation, Project Orbis and improving patients access to new therapies, as well as a report on medtech companies’ preparation for EU Medical Device Regulatio...

This article is a summarized translation of the most recent regulation published by China’s National Medical Products Administration (NMPA) on postapproval changes (PACs). The author provides an overview of the regulation and its annexes for PACs and discusses their impact on manufacturing site change management, change classification determination and consultation, and reporting categories.   Introduction On 13 January 2020, the NMPA published an announcement on t...

After COVID-19 quickly spread from China to nearby Asian countries in early 2020, regulatory authorities in those neighboring countries adapted rapidly to introduce regulatory pathways for approval of in vitro diagnostic (IVD) test kits to facilitate widespread testing and halt spread of the disease. An additional challenge was that authorities had to work around strict quarantine restrictions, and applications and consultations had to be conducted online instead of in per...