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Basic data
| Standard ID | GB/Z 130-2025 (GB/Z130-2025) |
| Description (Translated English) | Post-market surveillance of medical devices for manufacturers |
| Sector / Industry | National Standard |
| Classification of Chinese Standard | C30 |
| Classification of International Standard | 11.040.01 |
| Word Count Estimation | 42,476 |
| Date of Issue | 2025-12-03 |
| Date of Implementation | 2025-12-03 |
| Issuing agency(ies) | State Administration for Market Regulation, Standardization Administration of China |
GB/Z 130-2025: Post-market surveillance of medical devices for manufacturers
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GB /Z 130-2025.Post-market surveillance of medical devices by manufacturers
ICS 11.040.01
CCSC30
National Standardization Guiding Technical Documents of the People's Republic of China
Post-market surveillance of medical devices by manufacturers
(ISO /T R20416.2020,Medicaldevices-
Published on 2025-12-03
State Administration for Market Regulation
The State Administration for Standardization issued a statement.
Table of contents
Preface III
Introduction IV
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4.The purpose of post-market surveillance 2
5.Post-market monitoring planning 3
5.1 General Provisions 3
5.2 Scope of the Post-Market Monitoring Program 4
5.3 Objectives of the Post-Market Monitoring Program 4
5.4 Responsibilities and Authority 6
5.5 Data Collection 6
5.6 Data Analysis 7
5.7 Data Analysis Report 9
5.8 Interface with other processes 9
6.Review of the post-market monitoring plan 10
6.1 Purpose of the Review 10
6.2 Guideline 10
6.3 Review 10
Appendix A (Informative) Example 11 of Data Sources
Appendix B (Informative) Example 18 of Data Analysis Methods
B.1 General Provisions 18
B.2 Overview Table. Data Analysis Methods 18
B.3 Descriptive Methods for Trend Analysis 19
B.4 Descriptive Methods. Bar Chart 20
B.5 Descriptive Methods. Pareto Analysis 21
B.6 Qualitative Techniques 22
Appendix C (Informative) Example 23 of Post-Market Monitoring Plan
C.1 Example 23 of a post-market surveillance program for surgical scalpels
C.2 Example 24 of Post-Market Surveillance Plan for Radiotherapy Systems
C.3 Example of a post-market surveillance program for drug-eluting stents 27
C.4 Example of a post-market monitoring plan for a blood glucose monitoring system 29
C.5 Example 30 of Post-Market Monitoring Plan for Large IVD Analyzers
References 33
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting.
This document is equivalent to ISO /T R20416.2020, "Postmarket surveillance of medical device manufacturers". The document type is determined by ISO technical standards.
The technical report has been adjusted to become a national standardization guiding technical document in my country.
The following minimal editorial changes have been made to this document.
---To align with existing standards, the standard's name has been changed to "Manufacturers' Post-Market Surveillance of Medical Devices";
---Change the citation criteria in the introduction of Chapter 3 from the references to normative citations (see Chapter 2).
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Device Quality Management and General Requirements (SAC/TC221).
This document was drafted by. Beijing Guoyi Medical Device Huaguang Certification Co., Ltd., China National Institutes for Food and Drug Control, and Shandong Weigao Group Medical High-Pressure Certification Center.
Molecular Products Co., Ltd., Neusoft Medical Systems Co., Ltd., Shanghai United Imaging Healthcare Co., Ltd., and Aibonuo.
(Beijing) Medical Technology Co., Ltd., Kangtai Medical Systems (Qinhuangdao) Co., Ltd., Shandong Xinhua Medical Instrument Co., Ltd.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Hangwei GE Healthcare Systems Co., Ltd., and Henan Tuoren Medical Devices Group Co., Ltd.
company.
The main drafters of this document are. Chang Jia, Li Xin, Zheng Jia, Shao Yubo, Li Chong, Liu Lina, Deng Gang, Zhao Yan, Chen Fang, Xia Xiwei, and Wang Shaohua.
Li Xueyong, Ge Yang, Hu Yulong, Han Qiang, Zhang Jing, Liu Rongmin, Wang Tingting, Huang Shuming.
Introduction
When medical devices are designed, developed, manufactured, and marketed globally, residual risks related to the safety and performance of the medical devices remain in the product.
It exists throughout the entire lifecycle. This is due to a combination of factors, such as product variability, factors affecting the environment in which medical devices are used, and different...
End-user interaction and unforeseen medical device malfunctions or misuse. Medical device design and development activities ensure product release...
The residual risk before (i.e., before market launch) is acceptable. However, collecting and analyzing information about the medical device during the manufacturing and post-manufacturing stages is crucial.
It is important to meet monitoring requirements for products and processes and ensure that residual risks remain acceptable. Collecting and analyzing information related to production and processes is crucial.
Appropriate post-feedback processes can detect any adverse effects early. These processes can also reveal the implications specified in GB/T 42061-2022.
Improvement opportunities or potential safety relevance as specified in GB/T 42062-2022.
Post-market surveillance refers to the process of collecting and analyzing data on medical devices in actual use, enabling manufacturers to conduct such monitoring.
The process, and the use of data from post-market surveillance in appropriate processes (such as product realization, risk management, communication with regulatory agencies, or product improvement).
Information. The scope of post-market surveillance procedures needs to be appropriate and commensurate with the medical device and its use.
This document aims to provide guidance for manufacturers planning and implementing post-market surveillance activities. It addresses the relationship between manufacturers and the product lifecycle.
Other organizations that play a role in post-market surveillance activities, such as importers, distributors, and reprocessors, can also use the guidance in this document.
Its activities. Where applicable, this document will use "organization" instead of "manufacturer".
The post-market surveillance guidelines described in this document are based on the provisions of GB/T 42061-2022 and GB/T 42062-2022 regarding production.
The requirements for post-market surveillance in conjunction with post-production activities are supplemented in Figure 1.
Legend.
---Settings requirements;
---Provide deliverables.
Figure 1.Relationship between this document and GB/T 42061-2022 and GB/T 42062-2022
Because other standards (such as GB/T 42061-2022 and GB/T 42062-2022) describe the data collected and distributed according to the application of this document.
The decisions and actions taken are based on the information analyzed; therefore, this document does not include these decisions and actions. The organization and implementation of post-market surveillance activities are...
Meet applicable medical device regulatory requirements. Although regulatory requirements are not described here, this document helps organizations meet these requirements.
This document uses the definition of post-market surveillance (with modifications) from GB/T 42061-2022.Users of this document should also note that this definition differs from the definition used after production.
The use of data-related terminology may vary across different jurisdictions and define different activities and responsibilities, such as market surveillance.
Post-market surveillance of medical devices by manufacturers
1 Scope
This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process complies with relevant regulations.
Relevant standards, especially GB/T 42061 and GB/T 42062.This document describes a proactive, systematic process that manufacturers can use.
Collect and analyze appropriate data to inform the feedback process and to meet applicable regulatory requirements, gaining experience from post-production activities.
The output of this process can be used for.
---As input for product realization;
---As input for risk management;
---Monitor and maintain product requirements;
---Communicate with regulatory agencies; or
---As input for the improvement process.
This document does not cover market surveillance activities conducted by regulatory agencies. This document does not specify provisions for activities arising from or following production processes, in accordance with applicable laws and regulations.
The regulations require manufacturers to take certain measures, but do not mandate reporting to regulatory agencies. This document does not replace or change post-market surveillance.
Applicable regulatory requirements.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 42061-2022 Medical device quality management systems – Requirements for regulatory purposes (ISO 13485.2016, IDT)
GB/T 42062-2022 Application of risk management to medical devices (ISO 14971.2019, IDT)
3 Terms and Definitions
The terms and definitions defined in GB/T 42062-2022 and GB/T 42061-2022, as well as the following terms and definitions, apply to this document.
The URLs for the terminology databases maintained by ISO and IEC for standardization are as follows.
3.1
Post-market clinical follow-up study
PMCF studyPMCF-study
Post-marketing approval studies aim to answer specific questions regarding the clinical safety or performance of medical devices used within the approved scope.
Problem (i.e., residual risk).
Note 1.Examine for factors such as long-term performance, occurrence of clinical events (e.g., delayed hypersensitivity or thrombosis), events specific to a particular patient population, or medical...
Issues such as the performance of the device in more representative provider and patient populations.
Note 2.Similar studies exist for in vitro diagnostic reagents (IVD), such as post-market performance follow-up studies (PMPF).
[Source. GHTF/SG5/N4.2010, modified]
...
