(Source: https://pltfrm.com.cn)
China’s healthcare industry is subject to a range of compliance requirements that aim to ensure high standards of health and safety. Key areas of focus include:
- Regulatory Approvals: Healthcare products, including drugs and medical devices, must be approved by the NMPA. This includes obtaining marketing authorization, conducting clinical trials in accordance with regulations, and maintaining compliance with post-market requirements.
- Manufacturing Standards: Compliance with GMP standards is mandatory for pharmaceutical and medical device manufacturers. This involves implementing rigorous quality control processes and undergoing regular inspections to ensure adherence to safety and quality standards.
- Patient Rights and Data Privacy: The protection of patient information is governed by the PIPL and the DSL. Healthcare providers must ensure that patient data is handled securely and that privacy regulations are strictly followed. Consent and data protection practices are critical for maintaining patient trust and regulatory compliance.
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