What is the unique identification of medical device udi

Regarding the unique identification of medical devices, before implementation, we briefly understand what "Unique Device Identification" (UDI) is a standardized coding management system. It is the unique identification code information of global medical devices, from production and transportation to A management system that is controllable and traceable from circulation to end-use management. Simply put, it improves the traceability and safety of medical devices and strengthens supervision, management and user safety.

1. What does the unique identification of medical devices consist of: UDI consists of two parts,

1. Device Identifier: (Device Identifier, DI) information content contains basic information of the medical device, such as manufacturer and model.

2. Product identifier: (Production Identifier, PI) This part of the information contains the production information of the device, such as production date, batch number or serial number, etc. PI helps with traceability and lifecycle management of products in the event of product recalls or problems.

2. Classification definition of medical devices: The classification of medical devices can be divided according to their risk level, technical complexity and intended use.

1. Class I medical devices: refers to medical devices that have no direct effect on the human body and only diagnose, monitor, treat, alleviate or supplement the human body through physical or other indirect means, and prevent human diseases.

2. Class II medical devices: refer to medical devices that have a direct effect on the human body, but may pose minor risks after use and require registration review and approval. Such devices generally involve a certain degree of technical complexity and risks, and require strict supervision and management.

3. Category III medical devices: refer to high-risk medical devices that have a direct effect on the human body and may pose greater risks after use, and need to be approved for sale through strict review procedures.

3. Medical device unique identification system rules:

The unique identification system of medical devices is to ensure the traceability and management of medical devices in the production, circulation and use process. Standards and rules are usually formulated by relevant national departments or international organizations.

1. Uniqueness; each medical device needs to have a unique identification code to ensure accurate tracking and identification worldwide.

2. Identification content; identification codes usually include key information such as the product's globally unique identifier, manufacturer information, product model, production date, batch number, etc.

3. Identification form; the identification code can be a one-dimensional code, a two-dimensional code or an RFID electronic tag to Store the data.

4. Traceability; the identification system needs to ensure that the production and circulation of medical devices can be traced back to facilitate traceability and recall when product quality or safety issues arise.

5. Standardization; the identification system needs to comply with relevant international standards and specifications to ensure uniform implementation in different countries and regions.

6. Compliance; manufacturers need to comply with relevant laws, regulations and regulatory requirements to ensure that the marking system of medical devices meets compliance requirements.

4. Medical device labeling management regulations;

Medical device labeling management regulations are usually formulated by relevant departments of various countries or international organizations, and are specified in accordance with the laws, regulations and regulatory systems of different countries.

1. Label application and registration; manufacturers need to submit a medical device label application to the relevant regulatory agency and register the label information into the designated database.

2. Label updates and changes; manufacturers need to promptly update and maintain medical device label information, including changes in key information such as product model and batch number.

3. Standard use of logos; manufacturers need to mark identification codes on medical device products in accordance with the prescribed logo form and location, and ensure that the logo is clearly visible and difficult to wear or tamper with.