(Source: https://pltfrm.com.cn)
In China’s healthcare sector, compliance is crucial to ensure the effective and ethical operation of medical and pharmaceutical businesses. Essential compliance areas include:
- Pharmaceutical Regulations: The Drug Administration Law and related regulations require pharmaceutical companies to meet stringent standards for drug safety and efficacy. This involves obtaining approval from the NMPA for new drugs, conducting clinical trials, and adhering to post-market surveillance requirements.
- Medical Device Regulations: Medical devices are regulated under the Medical Device Regulations, which include requirements for product registration, quality management systems, and clinical evaluations. Companies must ensure their devices meet safety standards and obtain necessary certifications before market entry.
- Ethical Standards: Compliance with ethical standards, including patient consent and transparency, is mandated by laws such as the Biosecurity Law. Companies must follow ethical practices in clinical research and patient care to ensure trust and integrity in healthcare services.
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