Overview of the NMPA UDI System in China
This Article deals with the New Rules for Unique Device Identification System. The Chinese NMPA has Released a New Article talking about the UDI System for the Territory of the People’s Republic of China which was published on June 30, 2022.
Scope of the New UDI Rules for Medical Devices
The New UDI Rule is for the medical devices that are sold and used within the territory and their UDI system shall comply with the requirements of the Rules. This Includes Unique Device Identification (UDI) and Unique Device Identification Database (UDID). This System shall be constructed by actively referring to International Standards and following the principles of guidance by regulatory authority. The UDI shall include the device identifier (UDI-DI) and the production identifier (UDI-PI). The UDI-DI shall be the only code to identify the registrant / filing entities, models and other specification and packaging of medical devices and the UDI-PI shall be composed of the code to identify the relevant data in the production process of a medical device. The code issuing agencies will be the corporate entities within the territory of China, and possess the complete management system and operation system, so as to ensure the uniqueness of the UDI created as per its standards and in compliance with relevant requirements for the national data security.
Impact of NMPA UDI Regulations on Medical Device Companies
The NMPA shall formulate the relevant standards and the specifications that are applicable to UDI data, and organize the establishment of the UDID for public reference. The UDI data carrier shall satisfy requirements such as the Automatic Identification and the Data Capture (AIDC) and Human Readable Information (HRI). When the sale or use of any Medical Device is suspended, the UDI number can not be used on any Medical Device. To understand more on the UDI Requirements, Click Here
Connect with Us
Subscribe to our Website for the Medical Device Rules and Regulations wherein you can stay updated on the latest Medical Device Rules across the world. Contact Morulaa for additional Consultation or information on MDR in India and South East Asia.
Source: Link