QME tips in response to the storm of CFDA inspection
Two tips are provided here in response to the recent feedback from manufacturers regarding two aspects against which CFDA requirements are tightening.Interpretation of regulations Conformity certificate of productsAn “approved by inspection” certificate shall be included in each package for both imported and domestic products, in either of the following forms:1. A card that reads “approved by inspection” placed in the package as the conformity certificate of the product;2. An outstanding mark of “approved by inspection”, bold and framed, added directly as part of the label.
Regulation Basis
1. Clause 42 of Administrative Rules of the Supervision and Administration of Medical Devices2. Clause 59 of Administrative Rules of the Supervision and Administration of Medical DevicesAbout date in the IFU and label1. Manufacture date, shelf life or expiry date must be included in the IFU.Shelf life must be defined in the IFU, but manufacture date and expiry date are usually marked with a reference to the outer package.2. Manufacture date, shelf life or expiry date must be included in the label.Depending on the specific product, the details can be selected as needed, such as “manufacture date & shelf life”, or “manufacture date & expiry date”. The date must be in a complete year-month-date form.
Regulation Basis1. Clauses 10 （10） and 13 （5）of Regulations on Manuals and Labeling of Medical Devices2. Clause 60 of Administrative Rules of the Supervision and Administration of Medical Devices
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