China National Medical Products Administration recently issued the National Medical Device Sampling Inspection Product Inspection Plan for 2024, requiring local drug regulatory departments to organize relevant inspection institutions to carry out inspection work in accordance with the mandatory standards for medical devices and the technical requirements of registered or registered products.
According to the sampling plan, the sampling of national medical devices in 2024 included 66 products such as medical protective masks, breast implants, soft contact lenses, electronic endoscopes, ultrasound treatment equipment, high-frequency electric knives, electrocardiogram machines, strong pulsed light therapy instruments, and vascular stents.
The sampling inspection plan puts forward the specific requirements of the inspection basis, inspection items and comprehensive judgment principles, and clarifies the initial inspection and re-inspection mechanism of the product. For the requirements of re-examination, it is clarified that the re-inspection acceptance department of state supervision and sampling inspection in 2024 shall be the provincial pharmaceutical supervision and administrative department in the place where the medical device registrant, recorder or import product agent is located. Those who are clearly risk monitoring and spot checks in the inspection plan shall not be re-inspected.
Reporter: Meng Gang
Source: China Consumer Daily
Post time: Apr-02-2024