YY/T 1753-2020Reporting guide of unique device identification database (English PDF)
医疗器械唯一标识数据库填报指南
This is a limited preview
Buy now to download the full PDF (19 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1753-2020 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 30, 2020
Implementation date
October 1, 2020
Scope
YY/T 1753-2020 is the English-translated version of 医疗器械唯一标识数据库填报指南.
YY/T 1753-2020 is the Chinese pharmaceutical industry standard that sets the basic requirements for reporting a product's identification and the related information to the unique device identification database.
It covers who reports, when the data must be submitted and updated, the form in which they are submitted and the checks made on them, so that the record in the database stays true to the device on the market. Issued on 30 June 2020, it has applied since 1 October 2020.
Found what you need?
Document preview — YY/T 1753-2020
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative References4
- 3 Terms and Definitions4
- 4 Abbreviations4
- 5 Reporting Mode of Data5
- 6 Requirements for Data Interface Exchange Format5
- 7 Content of Data Reporting12
- 8 Security Requirements for Data Reporting12
- Appendix A (Informative) Reporting Example Instructions of the Basic Information of Unique Device Identification Database13
- Appendix B (Informative) Example of Interface Format for Data Reporting of Unique Device Identification Database17
- Bibliography19
Foreword
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
Please note some contents of this document may involve patents. The issuing agency of this document shall not assume the responsibility to identify these patents.
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.
4 Abbreviations
The following abbreviations are applicable to this document.
5 Reporting Mode of Data
It may be reported by three modes. webpage reporting, data template import and data interface exchange.
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.
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.
8.3 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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1753-2020
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
YY/T 1752-2020 — Basic data set of unique device identification database
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
Secure payment via Stripe
Payments accepted
YY/T 1753-2020
$270.00