How to submit UDI information for the GUDID system of medical devices required by the FDA?

The U.S. Food and Drug Administration's (FDA) new rules that have attracted the attention of domestic companies include the following:

The first is to require that each UDI identification code must include a device identification code and a production identification code, in which the equipment identification code is related to the version or model of the equipment and the OEM, and the production identification code must provide a variety of information, including product batch, model, production date, expiration date, etc., using automatic identification technology such as number, barcode identification and scanning, and marked in English text form.

The second is to require labelers to submit relevant product information to the Global Database of Identification Numbers for Special Devices (GUDID) managed by the FDA. This is a publicly searchable database that retrieves data other than patient information.

The third is to stipulate that most high-risk implantable devices such as pacemakers and defibrillators will be subject to UDI supervision within the first year; Most medium-risk medical devices will be compliant within three years; Low-risk products will be exempt from some or all of the UDI, and bulk packaging products such as bandages will share a single UDI code.

Freda Medical Consulting is at your service.

Steps to apply for a UDI code (UDI public platform).

1.Choose the right company's code issuing agency.

2.Make a UDI declaration.

3.Open it. Register for free, complete the enterprise information authentication and obtain the enterprise code;

4.After registration, according to the actual situation of the enterprise, select the service version (basic edition, advanced edition) to pay the fee;

5.Login. Complete the registration in the office hall of the Food and Drug Administration;

6.Go back to the UDI public platform, obtain DI codes in batches and apply to the NMPA with one click;

7.Generate PI codes in batches and dock with label printing equipment;

8.UDI label design and label attaching.

Unique Device Identification (UDI) is the identity given to a medical device throughout its life cycle, and it is its unique "ID card" in the product chain. The global adoption of a unified and standard UDI is conducive to improving the transparency and operational efficiency of the ** chain; Conducive to reducing operating costs; It is conducive to the realization of information sharing and exchange; It is conducive to the monitoring of adverse events and the recall of problematic products, improving the quality of medical services and ensuring patient safety. Yibo Testing can help enterprises apply for UDI code.

Look at the way they approve, and if they are approved by the PMA, they will be checked on the PMA database, otherwise they will be checked on the 510 (K) database.

The FDA medical device database is publicly available and can be queried, and you need to log in to the FDA official **. If you don't know how to make an enquiry, you can contact us to assist you with your enquiry.

The US FDA is an abbreviation for Food and Drug Administration, which is the United States Food and Drug Administration. The U.S. FDA has no template or standardized style for medical device labeling, and each product itself has different identification methods, and the labels for distributors that need to be reprocessed and for consumers are not the same, so there is no standardized style. However, the US FDA does have requirements for the English labeling of products.

The FDA understands the ingredients, uses, applicable groups and usage methods of products through product labeling, and the labeling of regulated products is an important means for FDA to supervise medical device products exported to the United States and circulated in the United States, so label compliance is not limited to a certain regulation. Label violations are based on thousands of pages of federal regulations, the Federal Register, the EAFUS database, GRAS bulletins, guidance documents, labeling guidelines, and warning letters.

To be precise, the US FDA does not certify most products, but the FDA's GMP believes that companies involved in the configuration, dissemination, synthesis, and processing of medical device products in the United States must ensure that the English labeling of products is compliant, including labeling, packaging and repackaging enterprises.

If the U.S. FDA finds that a company has a label violation, then the FDA has the right to raise questions, request rectification, detain the goods, refuse entry of the goods, put the company on the import alert that is automatically detained without inspection, issue warning letters, and so on. There are many companies that have been placed on import alert because of their labeling, not to mention the number of goods that have been denied entry. Therefore, the compliance of the English label of the product is very important.

U.S. market requirements.

Packaging & Labeling:

1 Product name, model number.

2 Manufacturer or Distributor Information.

3. Batch number or serial number and temperature unit.

4. The product conforms to the American standard logo.

Instructions: 1. Instructions for the product to comply with American standards.

2. Detailed instructions for use.

3 The way the product is cleaned and disinfected.

4. Calibration instructions and frequency.

5 Product Detailed Specifications.

6. Explanation of the operating environment and other reasons for the deterioration of the accuracy of the product.

7 Service & Repair Manuals.

8. Name and address of the manufacturer or distributor.

Hope it helps.

MostlyClass II medical devicesThe product is exported to the United States and needs to be obtained510(k)FDA registration.

1. 510(k) Meaning:

A 510(k) document is a premarket application filed with the FDA to demonstrate that the device being applied for marketing is as safe and effective as a legally marketed device that is not subject to premarket approval (PMA).etcValence device SE (substantially equivalent)。The applicant must compare the device applied for marketing with one or more similar devices currently on the U.S. market and conclude that the device is equivalent and supportive.

2. A reference to a 510(k) must be submitted:

1. Domestic manufacturers who introduce medical devices into the U.S. market;

2. Standard-setters for the introduction of medical devices into the U.S. market;

3. Repackaging or relabeling that changes the labeling or operation seriously affects the medical device;

4. The U.S. party of the foreign manufacturer exporter or foreign manufacturer exporter who introduces medical devices into the U.S. market.

orMedical devices 510(k).For more information, please contact our company, Registrar Corp

A 510k is a medical device that must be registered for commercial sale and must submit a premarket notification at least 90 days in advance. There are three types of situations in which a 510(k) may be filed:

a. The first commercial distribution (listing).

After May 28, 1976 (the effective date of the FDA&C ACT's medical device amendments), anyone wishing to ** a medical device in the U.S. is required to file a 510(k) application at least 90 days prior to the device's market. If the device was not marketed by your company prior to May 28, 1976, a 510(k) is required.

b. Different purposes of use are proposed for marketed devices. Specification 510(k) (21 CFR 807) specifically requires the filing of a premarket notification for major changes in the purpose of use. The purpose of use is indicated in the label of the device or in the advertised statement.

However, if the intent does not change completely, most changes require a 510(k).

c. Changes or improvements to marketed devices, if the changes can seriously affect the safety or effectiveness of the device.

It is the responsibility of the applicant to determine whether the improvement is capable of significantly affecting the safety or effectiveness of the device. Whatever conclusion is reached, a record should be made that can be reflected in the master record of the device, and the control record can be changed under the requirements of the medical device quality management practice. If asked, the applicant will be able to demonstrate that the change has been evaluated.

A new, complete 510(k) document is required if changes or alterations have been made to an existing device that significantly affects the safety or efficacy of the device, or where the guidelines for the marketed device are new or different from the original. To learn more, you can go to Orshida...

The 510(k) rule does not specifically specify who must file a 510(k), but it is required to file back if the device is introduced into the U.S. market. There are also actions that require a 510(k)1) filing with the FDA for domestic manufacturers who introduce devices into the U.S. market; 2) Regulators for the introduction of devices into the U.S. market; 3) Repackaging or relabeling that changes labeling or operation seriously affects the device; 4) The U.S. party of the foreign manufacturer exporter or the foreign manufacturer exporter who introduced the device into the U.S. market. For more information, please visit Aoshida.

In fact, there is no need to ask here, netizens' answers may not be accurate or comprehensive, go to the Food and Drug Administration, there is a special guide to handle different businesses, and there is a detailed guide printed.

Your question is too general, you can check the score of the product you are looking for

class, generally the second class of products should do 510 (k), a small number of class capacity also need to do 510 (k), you had better go to the FDA official website to find the three-letter product number of your product, you can determine the classification.

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