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YY/T 1753-2020 (YYT1753-2020)

YY/T 1753-2020_English: PDF (YYT 1753-2020, YYT1753-2020)
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BASIC DATA
Standard ID YY/T 1753-2020 (YY/T1753-2020)
Description (Translated English) Reporting guide of unique device identification database
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040; 35.240.01
Word Count Estimation 18,160
Date of Issue 2020-06-30
Date of Implementation 2020-10-01
Drafting Organization National Medical Products Administration Information Center, China National Institute of Standardization, Chinese People's Liberation Army General Hospital
Administrative Organization State Drug Administration Information Center
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

Standards related to: YY/T 1753-2020

YY/T 1753-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040; 35.240.01
C 30
Reporting Guide of Unique Device Identification Database
ISSUED ON: JUNE 30, 2020
IMPLEMENTED ON: OCTOBER 01, 2020
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Abbreviations ... 4
5 Reporting Mode of Data ... 5
6 Requirements for Data Interface Exchange Format ... 5
7 Content of Data Reporting ... 12
8 Security Requirements for Data Reporting ... 12
Appendix A (Informative) Reporting Example Instructions of the Basic
Information of Unique Device Identification Database ... 13
Appendix B (Informative) Example of Interface Format for Data Reporting of
Unique Device Identification Database ... 17
Bibliography ... 19
Reporting Guide of Unique Device Identification Database
1 Scope
This Standard specifies the basic requirements for reporting the product identification
and related information to the unique device identification database (referred to
database for short).
This Standard is applicable to the reporting of the unique device identification database.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) is applicable to this document.
YY/T 1752-2020 Basic Data Set of Unique Device Identification Database
3 Terms and Definitions
For the purposes of this document, the following terms and definitions given in YY/T
1752-2020 apply.
3.1 Data interface
The interface for transferring data and exchanging information between computer
software systems, which is realized in the form of electronic files.
4 Abbreviations
The following abbreviations are applicable to this document.
XML: Extensible Markup Language;
JSON: JavaScript Object Notation.
5 Reporting Mode of Data
It may be reported by three modes: webpage reporting, data template import and data
interface exchange.
When the webpage reporting is adopted, report the relevant data according to the
webpage reporting prompt. Please refer to Appendix A for the content of data reporting.
When the data template import mode is adopted, the data shall be reported according
to the data template provided by the unique device identification database. The data
format and content shall meet the relevant requirements of the data template, and then
the database shall be imported. Please refer to Appendix A for the content of data
reporting.
When the data interface exchange mode is adopted, the data interaction interface shall
be developed. After registering through the database docking service, the data
exchange relationship may be established with the database. The data interface
exchange format may adopt two formats, namely, XML and JSON. See Appendix B for
format examples.
6 Requirements for Data Interface Exchange Format
6.1 XML format
When using the XML format to transmit the data records corresponding to the database
basic information data subset, the data records shall be described as the udid element.
The XML format rules of the udid element are shown in Figure 1, and the specific
description can refer to B.1, where:
--- datasetName element: name of data record;
--- dataset element: basic information list element, including one or more data
elements;
--- data element: contains all the contents in a data record, composed of multiple
data items and data item values;
--- uploadType element: type of data declaration, “add” is addition, “modify” is
modification and edition, which is used to identify the type of business operation;
--- deviceRecordKey element: the unique minimum sales unit product identification
record code that is generated by the database. When the type of data declaration
is “modify” for modification and edition, this field is required;
--- devicePackage element: packaged product identification information list element,
Figure 2 – Continued
7 Content of Data Reporting
The content of data reporting for the unique device identification database shall include
the content of 7.1 in YY/T 1752-2020.
8 Security Requirements for Data Reporting
8.1 Access authentication
During data transmission, the database shall authenticate the applicant and verify the
corresponding request authority.
8.2 Data encryption
During data exchange, if sensitive information is involved, data encryption shall be
carried out in accordance with the relevant requirements of the database.
8.3 Transmission security
Data transmission shall use a secure transmission protocol.
8.4 Message status receipt
During data exchange, the database shall return a message status receipt containing
the processing result to the applicant.
8.5 Logging
The database shall record the data interface call request and warn of abnormalities.
“[Short name of data item m.n]”: “[data item value m.n]”
...