1、What is the shelf life of medical devices?

It refers to the time period when the medical device can play the proposed role after forming the end product. The end of the shelf life is the expiration date of the product. After this period, the medical device product will probably no longer have the expected performance parameters and functions.

2、What are the factors that affect the expiration date of medical device shelves?

External factors mainly include.

Storage conditions, transportation conditions, production methods, production environment, packaging, the impact of changes in the source of raw and auxiliary materials, other influencing factors, etc.

Internal factors mainly include

The performance of each raw material/component in medical devices; the possible interaction between each raw material/component in medical devices; the possible interaction between each raw material/component in medical devices and packaging materials (including preservation media, such as preservation fluid for corneal contact lenses, etc.); the impact of production processes on each raw material/component and packaging materials in medical devices; the medical devices containing The impact of radioactive substances and their by-products after radioactive decay on the raw materials/components and packaging materials in medical devices; the ability to maintain the microbial barrier in sterile packaging products.

Both internal and external factors can affect the technical performance index of medical device products to different degrees, and when the tolerance is exceeded, it can cause device failure.

It is important to emphasize that not all medical devices need to have a definite shelf life. When the performance of the raw materials and packaging materials of a medical device will not change significantly over time, it may not be necessary to determine a strict shelf life, while when the stability of a medical device is poor or the risk of clinical use is too high, its shelf life needs to be strictly verified.

3, what is the process of verification of the shelf life of medical devices by the registration applicant?

The validation of the shelf life of a medical device runs through the entire process of the device's development. The registration applicant should consider the shelf life of the medical device at the initial stage of its development and continuously confirm it during the process of product validation and improvement.

First, the registration applicant should set a shelf life for the medical device to ensure transportation, storage and expected efficacy. Jiayu testing network finishing, second, the registration applicant needs to be used for the production and packaging of medical devices, materials, components and related production processes, as well as the reference materials involved in a comprehensive assessment. If necessary, laboratory validation and adjustment of the production process is also required.

The registration applicant designs a validation program for the shelf life of the medical device based on the results of the evaluation, and determines the shelf life of the medical device based on the validation results obtained from the program. If the validation results are not accepted by the registration applicant, it is necessary to improve and re-validate after the improvement.

Registration applicants need to develop a strict quality system documents to ensure that the product in the shelf life of storage, transportation and sales.

4、What are the types of validation tests for the shelf life of medical devices?

Medical device shelf life validation test types can usually be divided into two types of accelerated stability test and real-time stability test.

(1) accelerated stability test

Accelerated stability test refers to a product placed under external stress, by examining the material degradation in the stress state, using the known acceleration factor and degradation rate relationship, inferring the material degradation of the product under normal storage conditions test.

It should be noted that when the raw materials/components of medical devices are prone to degradation and damage at high temperatures, the accelerated stability test should not be used to verify their shelf life.

(2) Real-time stability test

Real-time stability test refers to a product placed under predetermined storage conditions, until the monitoring of its performance indicators can not meet the requirements.

Real-time stability test, the applicant should be registered according to the actual production, transportation and storage of the product to determine the appropriate temperature, humidity, light and other conditions, the product is tested within a set time interval. Since most areas of China are subtropical climate, the recommended temperature and humidity conditions set in the validation test are: 25℃±2℃, 60%RH±10%RH.

Real-time stability test and accelerated stability test of passive implantable medical devices should be conducted simultaneously. Real-time stability test results are direct evidence to verify the shelf life of the product. When the accelerated stability test results are inconsistent with it, the real-time stability test results shall prevail.

5, medical device shelf life of the validation test testing, evaluation projects which categories?

Testing projects include product performance testing and packaging system performance testing.

Product performance testing needs to choose the physical and chemical testing items closely related to the shelf life of medical devices, involving product biocompatibility may change the medical device, biological evaluation is required. If applicable, packaging seal integrity testing can be used to replace sterility testing.

Packaging systemic testing includes packaging integrity, packaging strength and microbial barrier properties and other testing items.

6, medical device shelf life is the validation test reference standards are what?

7、How to extend the shelf life of medical device products?

Because the existing registration certificate and its annexes have been contained in the shelf life of soft contact lens products, should be changed in accordance with the licensing matters change procedures. It is recommended to refer to GB/T 11417.8-2012 "Ophthalmic Optical Contact Lenses Part 8: Determination of Expiry Date" to carry out shelf life study. Declaration of the need to provide a complete real-time aging study report.

8, medical device product shelf life is shortened, whether the application for change in licensing matters do not need to submit technical documents?

Although the product shelf life is shortened, the product in the storage cycle to reduce the risk of quality changes, but the registrant in the application for changes in licensing matters, it is recommended to provide a reasonable explanation and the necessary supporting information, such as the completion of real-time stability testing found that the product shelf life should be shortened, it is recommended to provide the real-time stability test verification information.