Non-active Device

It is necessary to clarify method and parameters of heat treatment of the product, evaluating and verifying the suitability of the heat treatment method. The basis for determining the heat treatment parameters (including heating time, holding temperature, holding time, etc.) and the acceptability criteria of the results after heat treatment also need to be clarified.

This module is not recommended for registration with the ventilator.
In clinical practice, the cardiopulmonary impedance indicator can be used as a reference to adjust the parameters of the ventilator. When the data reaches the adjustment indicator, the physician judges whether it is necessary to make adjustment and records the subsequent patient-related data, so as to evaluate whether the parameter indicator have positive adjustment, negative adjustment or no impact on the main effectiveness evaluation indicators.

According to Guidelines for Technical Review of Animal-based Medical Device Registration (2017 Revision), to apply for the registration of animal derived medical devices, the description of the process of inactivating and removing viruses and / or infectious factors in the production process and the effectiveness verification data or relevant materials shall be provided.

The efficacy of virus inactivation can be validated through laboratory validation or from suppliers of animal-derived materials, or evaluated through literature or historical data. If the validation data submitted are not based on the data obtained from the validation of the declared product itself, an analysis and demonstration of its applicability shall be conducted

Some liquid products for in vitro assisted reproduction have entered the Catalogue of Medical Devices Exempted from Clinical Trials. For the products that are not in the catalogue, it is recommended to select appropriate clinical evaluation paths, including clinical trials and CER pathway, based on the actual characteristics of the declared products and the available supporting dossiers.

Risks vary in different animal sources, production processes and applicable products. For some common virus inactivation processes, such as organic matter, radiation, strong acid, etc., the processes and methods are relatively mature which have many references. Therefore, it is not necessary to carry out laboratory verification one by one. Instead, it can be considered to refer to biological evaluation, immune prototype evaluation, clinical evaluation and other methods, and replace them with literature and historical data. Regarding qualification, there are no relevant provisions in the current medical device regulations.

If a manufacturer intends to add more sterilization methods in a change of permission items, the corresponding sterilization verification data and test the sterility performance should be submitted. Any other performance changes caused by the addition of sterilization methods should be tested. For example, if ethylene oxide sterilization method is newly added, sterility test and ethylene oxide residue test must be added.