CFDA issued the revised version of “Passive Implantable Medical Device Shelf Validity Period Registration Guideline”

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CFDA issued the revised version of “Passive Implantable Medical Device Shelf Validity Period Registration Guideline”

On May 26th, CFDA issued a guideline of shelf validity period for passive implantable medical device.This guideline is a general requirement for passive implantable medical equipment shelf validity period and does not address other technical requirements.

The guideline is the revised version of “Passive Implantable Medical Device Shelf Life Registration Guideline” (CFDA, 2011)

Highlights of this revision:

1)     Changed Shelf Life to Shelf Validity Period

2)     Adjusted some wording

3)     Modified the definition of implanted medical equipment, consistent with the definition in "Medical Device Classification Regulation" (CFDA, No. 15).

On May 26th, CFDA issued a guideline of shelf validity period for passive implantable medical device.This guideline is a general requirement for passive implantable medical equipment shelf validity period and does not address other technical requirements.

The guideline is the revised version of “Passive Implantable Medical Device Shelf Life Registration Guideline” (CFDA, 2011)

Highlights of this revision:

1) Changed Shelf Life to Shelf Validity Period

2) Adjusted some wording

3) Modified the definition of implanted medical equipment, consistent with the definition in “Medical Device Classification Regulation” (CFDA, No. 15).

Passive Implantable Medical Device Shelf Validity Period Registration Guideline (2017 Revised)

This guideline is a general requirement for passive implantable medical equipment shelf validity period and does not address other technical requirements.

The guideline is the revised version of “Passive Implantable Medical Device Shelf Life Registration Guideline” (CFDA, 2011)

Highlights of this revision:

1) Changed Shelf Life to Shelf Validity Period

2) Adjusted some wording

3) Modified the definition of implanted medical equipment, consistent with the definition in “Medical Device Classification Regulation” (CFDA, No. 15).

1. Basic Requirements

a. Factors affecting Shelf Validity Period

External Factors:

1) Storage conditions, such as temperature, humidity, light, ventilation, air pressure, pollution, etc;

2) Transport condition, such as shaking and shock

3) Production method. Same medical device with different production method may have different shelf validity period.

4) Production environment, such as the cleanliness, temperature, humidity, microbial, air-borne particles of sterile medical device production site.

5) Packaging, for example, product packaged in different sized containers may have different shelf validity period

6) Changes in the source of raw and auxiliary materials, such as changes in supplier, purchase batch numbers,

7) Other factors, such as impact of changes in production equipment and cleaning agents, residual in cleaning the molds the equipment.

Internal factors:

1) The performance of the raw materials / components in the medical device, the degradation of the raw materials / components over time, leading to changes in their chemical properties, physical properties or expected functions, thereby affecting the overall performance of the medical device. Such as certain macromolecular materials and combinations of drugs, bioactive factors.

2) The possible interaction between the raw materials / components in the medical device.

3) The possible interaction between the raw materials / components in the medical device and the packaging material

4) The impact of production process on the raw materials / components, packaging materials, such as sterilization process.

5) The impact of radioactive substances contained in medical devices and their byproducts after radiation decay on raw materials / components and packaging materials in medical devices.

6) Retention of anti-microbial barriers in sterile packaging products.

Internal factors and external factors can affect the technical performance of medical devices When they exceeded the tolerance specification, they can cause equipment failure.

It is important to note that not all medical devices are required to have a definite shelf validity period. When the performance of a medical device and the performance of the packaging material do not have significant change over time, it may not be necessary to determine a strict shelf validity period. Additionally, when a medical device has poor stability or high-risk clinical use, the shelf validity period is required to be strictly verified. For a passive implantable medical device supplied in a sterile status, the applicant should designate a validated shelf validity period.

b. The Verification Process of Shelf Validity Period

1) The registration applicant should set shelf validity period for medical devices to ensure transportation, storage and expected effectiveness.

2) The registration applicant is required to conduct a comprehensive assessment of the materials, components and associated production processes used in the production and packaging, as well as the involved reference materials.

3) The registration applicant is required to set up a strict quality system document to ensure that the product is stored, transported and sold during the shelf validity period.

c. The content of shelf validity period verification

a) Verification test type

1) Accelerated stability test

Accelerated stability test refers to a test that can infer products’ degradation in normal storage condition by placing the products in external stressed state by correlating the accelerated known degradation factors with the rate of the degradation.

2) real-time stability test

A real-time stability test refers to placing products under predetermined storage conditions until it is noticed that its performance does not meet the specified requirements.

The real-time stability test and accelerated stability test of passive implantable medical devices should be carried out simultaneously. The results of the real-time stability test are direct evidence of the shelf validity period. When the acceleration stability test results are inconsistent with them, the results should be based on real-time stability test.

b) Verification test detection/ evaluation items

The applicant should set test items, test methods and determine standards in both accelerated stability test and real-time test methods. Testing items include product performance testing and packaging system performance testing.

  • Product performance testing: physical and chemical testing that is related to shelf validity period; biological testing if needed.
  • Packaging performance testing: packaging integrity, packaging strength and microbial barrier performance testing.

Registration applicant is suggested to set up multiple detection time points (usually no less than 3) during the test of passive implantable medical device.

c) The products in verification test

End products that are same with the products in conventional production should be used in medical device shelf validity verification test. At least 3 representative consecutive batches of products should be included.

d) Statistical methods in verification test

Applicants should set the number of test samples for each test item in the verification test plan to ensure that the test results are statistically significant and provide relevant information in the test report.

d. The reference standards

  • Basic requirements and quality system standards

ISO 11607-1; ISO 11607-2

  • Standards of packaging system testing methods

YY/T 0681.1; YY/T 0681.2; YY/T 0681.3; YY/T 0681.4; YY/T 0681.5; ASTM D 4169; ASTM F 1608

  • Packaging material standards

YY/T 0698.2; YY/T 0698.3; YY/T 0698.4; YY/T 0698.5; YY/T 0698.6; YY/T 0698.7; YY/T 0698.8; YY/T 0698.9; YY/T 0698.10

e. The technical documents required in registration submission

1) Basic information related to the shelf validity period of the product, including the raw materials / components, packaging materials, production technology, sterilization methods (if involved), shelf validity, storage and transportation conditions;

2) An assessment report of the relevant influencing factors in the verification process of medical device shelf validity period;

3) The test plan and test report of the real-time stability test.

4) If applicable, provide the test protocols and test reports for accelerated stability tests.

5) Packing process verification report and packaging, sealing equipment details;

6) Other relevant supporting information