NMPARULES66-2019 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| NMPA RULES66-2019 | English | 215 |
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NMPA Medical Device Unique Device Identification System Rules-No.66, 2019
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Similar standards NMPA RULES66 NMPARULES66-2019: NMPA Medical Device Unique Device Identification System Rules-No.66, 2019---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/NMPARULES66-2019
Announcement of National Medical Products
Administration (NMPA) on Issuing the Medical Device
Unique Device Identification System Rules
(No.66, 2019)
In order to implement the "Notice of the General Office of the State Council on
Printing and Distributing the Reform Plan for Governing High-value Medical
Consumables" (No.37, [2019] of the General Office of the State Council),
standardize the construction of Unique Device Identification System, and
strengthen the management of the full life cycle of medical devices; in
accordance with the "Regulations for the Supervision and Administration of
Medical Devices"; the NMPA has formulated the "Medical Device Unique
Device Identification System Rules". It is hereby issued and shall come into
force on October 1, 2019.
It is hereby announced.
National Medical Products Administration
August 23, 2019
Attachment: Medical Device Unique Device Identification System Rules
Attachment
Medical Device Unique Device Identification System
Rules
Article 1 In order to standardize the construction of Unique Device
Identification System, strengthen the management of the full life cycle of
medical devices, in accordance with the "Regulations for the Supervision and
Administration of Medical Devices", this Rules is developed.
Article 2 The unique identification system of medical devices sold and used
within the territory of the People's Republic of China shall comply with this Rules.
Article 3 The Unique Device Identification System referred to in this Rules
consists of the unique device identification, unique identification data carrier,
and unique identification database.
The unique device identification refers to a code composed of numbers, letters
or symbols attached to the product or packaging of a medical device. It is used
to uniquely identify the medical device.
The data carrier for the unique device identification refers to a data medium
which stores or transmits the unique identification of a medical device.
The database for the unique device identification refers to the database which
stores the product identification and related information of the unique device
identification.
Article 4 The construction of Unique Device Identification System shall
actively learn from international standards and follow the principles of
government guidance, enterprise implementation, overall planning, and step-
by-step implementation.
Article 5 The NMPA is responsible for establishing the policy for Unique
Device Identification System; formulating a plan for the construction of Unique
Device Identification System; encouraging all parties to actively apply the
unique device identification; promoting the management of the full life cycle of
medical devices.
The drug regulatory authorities of provinces, autonomous regions, and
municipalities directly under the Central Government are responsible for
guiding and supervising the registrants/filers in their respective administrative
regions to carry out work related to the construction of Unique Device
Identification System.
Article 6 The registrant/filer is responsible for creating and maintaining the
unique device identification in accordance with this Rules; assigning data
carriers for the unique device identification on the product or packaging;
uploading relevant data; using the unique device identification to strengthen the
management of the entire product process.
Encourage medical device production and operation enterprises and using
organizations to actively apply the unique device identification for related
management.
Article 7 The unique device identification includes product identification and
production identification. The product identification is a unique code for
identifying the registrant/filer, the model specification and packaging of the
medical device. The production identification is composed of the codes of the
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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