Registration of disposable light-proof infusion sets in China shall refer to the newly revised technical review guidelines issued (No.15 of 2023) by the China Centre for Medical Devices Evaluation (CMDE) on April 28, 2023. These guidelines outline the general requirements for registration application materials, which should be tailored to the specific characteristics of the product.
Scope
These guidelines apply to the registration of disposable light-blocking infusion sets. According to the medical device classification catalogue, light-blocking infusion sets are classified under code 14-02-05 and belong to Class III.
Registration review points
Light-protected infusion devices must comply with relevant standards such as YY 0286.3 “Special Infusion Sets – Part 3: Light-Protected Disposable Infusion Sets” and GB8368 “Disposable Infusion Sets – Gravity Infusion Type”. The technical requirements should be based on the product design features, clinical applications, and the “Guidelines for Compilation of Medical Device Technical Requirements.”
The performance indicators should comply with mandatory standards and industry requirements. If there are specific designs or additional features, corresponding performance indicators should be defined and included in the product technical requirements. Common performance items include light protection, decolorization, tube wall characteristics, sterility, endotoxin, among others.
Product instructions and labeling
Product instructions should comply with the regulations for management of medical device instructions, labels, and packaging, and the guidelines for technical review guidelines of disposable infusion devices. The following points should also be considered:
- Objectively describe the product’s transmittance test data for different wavelength ranges.
- Clearly indicate the product’s name, intended use, contraindications, and target population.
- Include warning information regarding drug compatibility.
Further information
Read the original CMDE amended technical review guidelines for the registration of disposable light-proof infusion sets in China.
By adhering to the outlined requirements, manufacturers can ensure their products meet the necessary safety and performance standards. Also, Cisema can assist manufacturers in navigating the registration process effectively. Discover our services for medical device registration, renewals and NMPA Legal Agent.
