Regulatory Strategy in China

Regulatory Strategy for Medical Devices in China
Regulatory Strategy for Pharmaceuticals/Drugs in China

Developing your Chinese regulatory strategy is one of the keys to success there. China's medical regulations are still evolving, with new regulatory rules being implemented every month.

Sometimes, your medical device may be classified one way in the U.S. but differently in China. If your medical device classification in China is not clear, you can summarize your rationale and the SFDA will send the information to hundreds of doctors throughout China for clarification.

In developing your pharmaceutical/drug strategy, how should you classify your products? Which drug registration strategy should you choose — a new drug application or an abbreviated drug application?

China is also currently overhauling its quality and GMP requirements for devices and drugs. If your strategy includes sourcing or manufacturing your medical products in China, you should be aware that the previously lax Chinese regulatory environment is becoming stricter.

PBM's regulatory experts can help your company determine the most cost-effective and time-efficient regulatory strategy for China.

For more information on regulatory issues in China, please see the following PBM publications and/or contact us to discuss your specific needs.

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