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China is one of the fast-growing medical devices markets with a rapid change in the regulations to improve the quality of the medical devices for the benefit of human health. China focuses on the high-tech imported medical devices which allow the manufacturers worldwide to sell their products in Chinese market. Before the worldwide manufacturers could sell their products in China, the technical documents of the products should be registered in Chinese market for NMPA approval. These technical documents should be in-line with the latest regulations in China.
This paper is about the remediation procedure of Product Technical Requirements (PTR) of medical device products (Orthopaedic devices) that is to be registered in China for the NMPA approval. It provides an overview of the PTR document which needs to be remediated to comply with the latest regulations of China. This paper provides also an overview of Orthopaedic implants, its classification based on Chinese medical market, Chinese regulations and its regulatory bodies, and Chinese standards to be followed for medical device registration.