On March 18, 2021, China’s State Council released a significant revision of the framework regulation for medical devices, the Regulation for Supervision and Administration of Medical Devices (“Revised RSAMD”), which will go into effect on June 1, 2021. The National Medical Products Administration (“NMPA”) subsequently released several draft updates to the corresponding implementing regulations for the Revised RSAMD on March 26, 2021.

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Photo of John Balzano 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…

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.

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Photo of Julia Post Julia Post

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Julia has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act…

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Julia has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act of 2009; human cells, tissues, and cellular and tissue-based products (HCT/Ps); market exclusivity; informed consent requirements; and pharmacy substitution practices.

Prior to joining the Food and Drug practice group, Julia was a member of the Litigation practice group where she focused on representing clients in Hatch-Waxman patent litigation.

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Photo of Muyun Hu Muyun Hu

Muyun Hu advises multinational and Chinese companies on a range of regulatory, policy, transactional, and litigation matters. Her work focuses on the life science industry, particularly with regard to food, drug, medical device, cosmetic, and other regulated products.

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Photo of Annie Wang Annie Wang

Annie Wang is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device and the Litigation and Investigations Practice Groups. She represents companies and trade associations on a range of regulatory, policy, and litigation…

Annie Wang is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device and the Litigation and Investigations Practice Groups. She represents companies and trade associations on a range of regulatory, policy, and litigation matters.

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