Dealing with China’s Regulatory Authorities Tips for Devicemakers
China’s medical device regulatory system has long been a puzzle to outsiders. With so many pieces, it’s not always clear how they fit together.
What is clear is that devicemakers that understand how to work the system have a distinct edge over those that don’t.
The hierarchical structure of China’s government consists of four tiers:
Central: the state food and drug administration (SFDA)
Provincial: agencies in 31 separate provinces
Prefectural: 293 agencies divided among the provinces; and
County: 2,800+ local authorities.
All of them play an important part in bringing your product to market in China.
Dealing with China’s Regulatory Authorities lays out the whole regulatory map — explaining which bodies are responsible for which groups of products and activities, what their particular interests are, how to deal with officials at different levels and what personal factors (education level, language, culture) should be taken into account. You will learn:
The differences among and interrelationships between the four levels of regulatory agencies, from the central to the local
How regulation of the three device classes is divided among the levels
The difference in China between “regulations” and “rules”
When products must be tested in China before being approved
To what regulatory level should clinical trial protocols be submitted
Trends in domestic device approvals vs. imported device approvals
Current trends in regulatory enforcement and anti-corruption practices
Characterization of officials in different levels of government and how best to deal with them
Dealing with China’s Regulatory Authorities helps you understand the hierarchical structure of China’s regulatory agencies and how to operate within the system.
Order Your Copy Today
PDF Edition — $177
Who Will Benefit
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.