Tiếng Việt
In recent times, Vietnam’s healthcare industry has had strong developments in technology and medicine. To ensure safety, efficiency and transparency in the use of medical equipment, managing and issuing circulation numbers for medical equipment becomes an important task. With the following article, let’s join Medgate to learn about medical equipment circulation numbers and the process of issuing medical equipment circulation numbers in Vietnam.
Procedure for granting circulation numbers of medical equipment in Vietnam
Concept of circulating number
The medical device circulation number is a unique code issued by the medical management agency to each medical device before the product is allowed to circulate on the market. The main goal of issuing a circulation number is to ensure that this medical device has been tested for quality, safety and effectiveness, and meets regulatory standards.
According to Clause 1, Article 21 of Decree 98/2021/ND-CP, the circulation number of medical equipment is the standard publication number applicable to type A and B medical equipment; Number of circulation registration certificate for type C and D medical equipment.
Steps in the circulation number granting process
The process of issuing circulation numbers for medical equipment in the Vietnamese market usually includes the following steps:
1. Register and submit medical equipment registration documents:
Businesses, manufacturers or importers of medical equipment must submit registration documents for issuance of circulation numbers to the management agency. This profile includes detailed information about medical equipment products, quality certifications, clinical trials and related technical documents.
2. Document appraisal:
The management agency conducts an appraisal of the medical device registration application to ensure that the information provided is accurate and complete. This appraisal process includes checking certificates, checking test results and evaluating the safety and effectiveness of the device.
3. Inspection and testing:
In some cases, the medical device regulatory agency may require additional inspection and testing to verify the information in the registration application. These tests are usually performed at independent and certified testing laboratories.
4. Issue of circulation number:
If the registration application fully meets the requirements and the medical device passes the testing tests, the regulatory agency will issue a circulation number for the medical device. The medical equipment circulation number will be recorded on the product label and in related documents.
Meaning of medical equipment circulation number
Guaranteed quality and safety
The medical device circulation number is proof that the device has been tested and certified for quality and safety. This helps users, including medical professionals and patients, feel more secure when using these devices during diagnosis and treatment.
Increasing transperency and accountability
The circulation number issuance process also helps increase transparency and responsibility of manufacturers and importers. By requiring full product information and undergoing strict testing steps, this process helps limit the risks associated with using substandard quality equipment.
Support for management and supervision
The circulation number of medical equipment also plays an important role in the management and supervision of medical agencies . Thanks to the medical equipment circulation number, management agencies can easily monitor and inspect devices on the market, thereby promptly detecting and handling arising problems.
Challenges in managing medical equipment circulation numbers
Large workload
With the continuous development of medical technology and the medical industry in general, a number of new medical equipment is constantly being born and put into use. This creates a huge amount of work for regulatory agencies in evaluating registration dossiers and issuing circulation numbers. To meet this need, management agencies need to have enough human resources to prepare documents, monitor progress and estimate finances.
Guaranteed updates and accuracy
Updating and maintaining the database of medical devices that have been granted circulation numbers is also a significant challenge for both management agencies and businesses. This information needs to be continuously updated to accurately reflect the current status of medical devices on the market. Any delay or error in updating information about medical equipment can lead to serious consequences in terms of safety and efficiency of use.
Dealing with counterfeit devices
On the market, the appearance of fake or unknown medical devices is a common problem today. These devices not only endanger users but also reduce the reputation of genuine manufacturers. Managing the circulation numbers of medical equipment can help detect and prevent counterfeit devices, but to do this requires close coordination between management agencies and relevant units. .
To learn more about medical equipment registration and the process to issue a medical equipment circulation number at MEDGATE , please contact Hotline: 098.546.1894 or Email: medgatevn@gmail.com for advice on the issues. Documentation services, procedures, quotes, registration, circulation announcement, and advertising of medical equipment.