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What is the difference between medical device registration and health product registration?
Release date:
2020-12-29 16:37
Source:
“Xiaozihao” products refer to disinfectant products, primarily used to kill or remove pathogenic microorganisms on vectors of transmission. They are a category of products approved by the Ministry of Health to enhance public health standards. These products are reviewed and approved by provincial-level health authorities, manufactured under official authorization, and may be marketed with claims of antibacterial or antimicrobial efficacy. The terms “Xiaozihao” and “Xiaozhengzihao” convey the same meaning; the distinction lies in their usage: “Xiaozihao” is the commonly accepted generic term for disinfectant products once they have obtained production approval, whereas “Xiaozhengzihao” is used in standardized official documentation.
The format for “Xiao”-type product registration numbers is: (Abbreviation of the province, autonomous region, or municipality directly under the central government) Wei Xiao Zheng Zi (Year of issuance) No. ××××. According to regulations, the labels and instructions of disinfectant products must not contain or imply any claims regarding therapeutic effects for diseases.
Medical device registration number: refers to the approval code or batch number for medical devices or products such as medicated plasters with health‑care functions. Medical device registration numbers are divided into three categories, and the corresponding registration certificates are uniformly printed by the **Food and Drug Administration; the relevant information is completed by the (food) drug regulatory authority that approved and registered the product.
Classification of medical devices: Classes I, II, and III—terms are managed according to these categories, as stipulated in the Regulations on the Supervision and Administration of Medical Devices. The regulatory hierarchy progresses from lower to higher levels.