Price & Delivery
US$215.00 ยท In stock
Delivery: <= 0 days. True-PDF full-copy in English will be manually translated and delivered via email.
NMPARULES66-2019: NMPA Medical Device Unique Device Identification System Rules-No.66, 2019
| Std ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status |
| NMPA RULES66-2019 | English | 215 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
NMPA Medical Device Unique Device Identification System Rules-No.66, 2019
| |
Standard similar to NMPARULES66-2019
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
Tips & Frequently Asked Questions:
Question 1: How long will the true-PDF of NMPARULES66-2019_English be delivered?
Answer: Upon your order, we will start to translate NMPARULES66-2019_English as soon as possible, and keep you informed of the progress. The lead time is typically in 9 seconds (download/delivered in 9 seconds). The lengthier the document the longer the lead time.
Question 2: Can I share the purchased PDF of NMPARULES66-2019_English with my colleagues?
Answer: Yes. The purchased PDF of NMPARULES66-2019_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.
Question 3: Does the price include tax/VAT?
Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs):
List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?
Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.