CMDE Release: Answers to Six Common Medical Device Questions

On January 7, CMDE released answers to six common questions, including research data on different batches of medical device products:

Q. Is it necessary to submit research data such as stability or packaging verification of different batches of medical device products (non in vitro diagnostic reagents)?

A.For most medical devices (non in vitro diagnostic reagents), the stability and validity of products usually depend on the raw materials used and aging mechanism, such as thermal aging, photoaging, etc. Under the condition that the performance of raw materials, production process and packaging materials remain stable, in principle, different batches shall not affect the stability and effectiveness of products. Therefore, whether it is necessary to submit research data such as stability or packaging verification of different batches of products should be considered in combination with product characteristics and technical requirements. If the products have particularity, such as containing bioactive substances, the submission of relevant research data of different batches can be considered.

Q.How to determine the temperature of real-time stability study of shelf life of passive medical devices? What information should be submitted?

A.Theoretically, the temperature for the real-time stability study of the product is generally the same as the storage temperature. If there are special provisions, the relevant provisions shall prevail, such as ophthalmic optical contact lenses Part 8: Determination of validity period (GB / T 11417.8-2012), which clearly stipulates that the temperature used for the stability study of corneal contact lens products is 25 ± 2 ℃.

For the medical devices required to be stored at room temperature, if there are no special regulations, in principle, the real-time stability verification is not mandatory. The temperature is 25 ℃ and 2 ℃, and the corresponding research data can be provided according to the product characteristics. For medical devices with special requirements for storage temperature, verification research shall be carried out according to the specified temperature.

Q.Is laboratory verification necessary for virus safety of animal derived products?

A.Different animal sources, production processes and applicable products scope have different risks. For some common virus inactivation processes, such as organic matter, radiation, strong acid, etc., the processes and methods are relatively mature, and there are many references, so it is not necessary to carry out laboratory verification one by one. For animal derived products, especially those with mature raw material application, literature or historical data can be used to evaluate the virus inactivation effect.

Q.Under what circumstances can an application for review of instruction change notification be submitted?

A.According to Article 16 of the regulations on the administration of instructions and labels of medical devices, if other contents of the instructions that are not within the scope of change registration change, it shall notify the approval department of medical device registration in writing, and submit relevant documents such as comparison description of the changes of the instructions.

After receiving the application for review of instruction change notification, our center will review the technical content of the application for instruction change notification with reference to the filing review requirements. If it is found during the examination that the application involves the need for the registrant to provide corresponding supporting materials, a notice of acceptance and correction will be issued, clearly indicating the specific problems existing in the application and the materials to be submitted by the registrant. If it is considered that it does not belong to the scope of the notice of change of the specification, the specific contents and reasons of the nonconformity will be clarified to the registrant in the notice of acceptance and correction, as well as the way to handle the registration according to the change.

Q.Do the material properties of medical device products need to be included in the technical requirements?

A.In principle, the material properties are not included in the performance indicators of product technical requirements, including but not limited to the chemical composition, microstructure and internal quality of metal products; Infrared spectrum of polymer products and materials; chemical composition, impurity element content, thermal conductivity and crystalline phase content of ceramic products and materials.

The material characterization information really related to product safety can be specified in the form of appendix in the technical requirements.

Q.Is it necessary to conduct in vivo metabolism research for absorbable medical devices?

A.Because raw materials of absorbable products can be absorbed by human body, there may be safety risks in their metabolism in vivo. However, for most mature materials, such as sodium hyaluronate, animal collagen, chitosan, starch, polylactic acid, etc., there are many relevant research literatures, and their metabolic path is relatively fixed, and the dose, cross-linking degree and individual differences have little impact on the metabolic path, Generally, it will not change significantly.

Therefore, for the product prepared from the above mature materials, in principle, it is not necessary to provide the in vivo metabolism research data of the product, which can be supported by providing the existing literature; or verify the safety of the product through biocompatibility evaluation. If the product uses a new absorbable material and lacks relevant research data on the metabolism of the material in vivo, the metabolism of the product in vivo needs to be studied.

Source: CMDE