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John Balzano

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with regard to products regulated by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.

He also advises on regulatory compliance, due diligence, and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries, and implementing product recalls. John also has significant experience designing strategies to handle professional consumer litigation for food and cosmetic companies operating in China and working with local counsel.

He advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.

John has particular experience in the U.S. advising on the requirements for the acquisition and transfer of biospecimens for research purposes.

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 devices regardless of whether they are imported or made in China.  Subsequently, NMPA added various appendices (fulu) to articulate special requirements for certain types of devices, including sterile, implantable, and in vitro diagnostic devices.    The Draft Appendix sets out proposed special requirements for software that falls under the definition of medical device.

In China, the definition of a medical device covers software that either itself constitutes a device (i.e., standalone software) or is an accessory/component of a device (i.e., component software).  The Draft Standalone Software GMP expressly applies to standalone software and it states that it applies, “by reference,” (mutatis mutandis) to component software.  If finalized, the Draft Standalone Software GMP would be effective on an undetermined date in 2020.

The Draft Appendix is a relatively simple document with four main sections:

  • scope and general principles of the Draft Appendix ;
  • special requirements for various aspects of the manufacturing and post-market processes (see below);
  • definitions of key terms; and
  • miscellaneous provisions.

Key features of the Draft Standalone Software GMP include the following:Continue Reading NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software

China continues to advance policy supporting e-healthcare services and resources.  On September 14, 2018, National Health Commission (“NHC”) and the National Administration of Traditional Chinese Medicine (“NATCM”) publicly released three new rules on internet based medical services and telemedicine.  These rules cover the areas of e-diagnosis (“e-Diagnostic Rules”), internet-based hospitals (“e-Hospital Rules”) and telemedicine services (“Telemedicine Service Standard”) (collectively “e-Healthcare Rules”).[1]

Although the government issued a draft of these rules in 2017, the final e-Healthcare Rules appear to have been prompted by the Opinion on Improving the Development of “e-healthcare” Industry (“Opinion”) issued by China’s chief executive branch, the State Council on April 25, 2018.  That Opinion requires enhancement and improvement of e-health services (including the application of artificial intelligence in the diagnostic process).

This blog entry focuses on key features of the e-Healthcare Rules.Continue Reading China Expands Regulations on e-Healthcare Issues