Guideline Of Passive Implantable Medical Device Shelf Life Registration Submitted Documents

Appendix
Guideline of Passive Implantable Medical Device
Shelf Life Registration Submitted Documents
(Revised Edition 2017)
I. Introduction
The shelf life of medical devices refers to the period during which the final products
of medical devices can perform their expected functions normally. Once the shelf life of
medical device is expired, it means that the devices may no longer meet the known
performance indicators and play the expected function. There are potential risks during use.
This guideline is formulated to further clarify the technical requirements of registration
materials for passive implantable medical device products and guide the applicant to
compile the shelf life registration data of passive implantable medical device. The shelf life
registration submission of passive non-implantable medical device can be carried out
according to the actual situation.
The guideline is a general requirement for the shelf life of passive implantable
medical devices, without involving other technical requirements. For the preparation of
registration materials for other technical requirements of the product, the registration
applicants shall also refer to the relevant regulations and guidance documents. If there are
other regulations and guidance documents relating to the shelf life of certain medical devices,
it is recommended that the applicants apply for registration in conjunction with this guideline.
The guideline is a guidance document for registered applicants and examiners, but
does not include administrative matters related to registration approval and is not enforced
by statute. If other methods are available to meet relevant regulatory requirements, they may
also be applied, the detailed research and validation information of which should be
provided. Applicants for registration shall use the guideline in accordance with relevant
regulations.
This guideline is formulated under the current regulations and standards system, and
according to the current cognitive level. With the continuous improvement of laws,
regulations and standards, as well as the continuous development of science and technology ,
the relevant content of the guideline will also be adjusted in due course .
This guideline is a revised version of “Guideline on Shelf Life Declaration of Passive
Implantable Medical Devices” issued by the China Food and Drug Administration in 2011.
This revision mainly involves the following content: (1) changing the term “shelf life” to
“shelf life” in the original “Guideline”; (2) adjusting some of the text expressions; (3)
modifying the definition of implantable medical devices to maintain consistency with the
Classification of Medical Devices (order No. 15 of China Food and Drug Administration).
II. Applicable Scope
This guideline is mainly applicable to the research on the shelf life of passive
implantable medical devices and the preparation of relevant registration data.
III. Basic Requirements
(I)Influencing factors of shelf life
The factors influencing the shelf life of medical devices mainly include external
factors and internal factors. Some of the factors closely related to passive implantable
medical devices are listed here, but are not limited to the following:
External factors mainly include：

1. Storage conditions, such as temperature, humidity, light, ventilation, air pressure,
   pollution, etc.
2. Transportation conditions, such as vibration, collision during transportation;
3. Mode of production, the same medical device products produced in different ways may
   have different shelf life;
4. Production environment, such as cleanliness, temperature and humidity, microorganism
   and suspended particle load of sterile medical device production site;
5. Packaging, for example, products packed in containers of different sizes may have
   different shelf life;
6. The impact of the change in the source of raw and auxiliary materials, such as the change
   of purchasing unit and purchase lot number;
7. Other influencing factors, such as the impact of changes in production equipment, the
   cleaning agents used in equipment and the mold release agents without cleaning after
   molding.
   Internal factors mainly include：
8. The properties of raw materials / components of medical devices, their raw materials /
   components degenerate with time, resulting in changes in their chemical properties,
   physical properties or expected functions, which will affect the overall performance of
   medical devices, such as drugs and biological activity factors in some polymer materials
   and combination products, etc.
9. The possible interactions between raw materials / components of medical devices.
10. The possible interactions between raw materials / components and packaging materials
    (including storage media such as the preservation solution of contact lens of cornea) of
    medical devices.
11. The influences of production processes on the raw materials / components and packaging
    materials of medical devices, such as the sterilization process used in the production
    process.
12. The influences of radioactive substances contained in medical devices and their byproducts after radioactive decay on the materials and components of medical devices
    and packaging materials.
13. The ability to maintain microbial barriers in aseptic packaging products.
    Both internal and external factors can affect the technical performance indicators of
    medical device products to varying degrees. When the tolerance is exceeded, the device can
    be invalidated. Because there are many influencing factors, it is impossible for registration
    applicants to circumvent all the factors that affect the shelf life of medical devices, but they
    should be controlled as effectively as possible to minimize the influences on the technical
    performance indicators of medical device