Dealing with China’s Regulatory Authorities: Tips for Devicemakers

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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:

  1. Central: the state food and drug administration (SFDA)
  1. Provincial: agencies in 31 separate provinces

  2. Prefectural: 293 agencies divided among the provinces; and

  3. 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.

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