Nowadays, there are numerous types of medical devices in the market with different purposes and varying levels of risk. Pursuant to Decree 98/2021/ND-CP on the management of medical devices, owners of medical equipment must classify and publicly disclose the classification on the online public service website of the Ministry of Health. This classification affects the process of obtaining import licenses, declaration of standards for class A and B medical devices, as well as registering circulation for Class C and D medical devices. Therefore, the accurate classification is crucial to avoid potential risks in the future
– Delayed progress: A consultancy company taking too long to provide classification results can impact the import and circulation timelines.
– Incorrect Classification detected by the Ministry of Health during the post-inspection process will be:
– Professional, Experienced Specialists: Our specialists consist of university pharmacy graduates with professional qualifications, expertise in legal matters, and years of experience working and training personnel in both domestic and multinational companies in the field of medical equipment
– Where to provide diverse services:
Medgate offers various services related to medical equipment, helping clients optimize costs and save time searching for reliable and professional service providers These services include:
– Quick classification time, commitment to the accuracy of medical devices classification results.
– Optimize costs for post-classification procedures with medical devices branch, family, and a set solutions.
Medgate’s service – Classification for medical devices
Medical Devices is classified into 4 types based on the level of potential risks related to the technical design and production of such medical equipment:
| Type | Risk Level | For example |
| A | Low risk | Nasal inhaler |
| B | Medium-low risk | Fluid transmission line |
| C | Medium-high risk | Respirator |
| D | High risk | Artificial heart valve |
– Request letter for medical equipment classification
– Instructions for use of medical equipment (in Vietnamese)
– Product catalog (Original product catalog in English)
– Summary technical documentation of the medical equipment in Vietnamese, along with technical documentation describing the functions of the medical equipment
– ISO 13485 Certification
– Certificate of Free Sale (CFS) for the product
– Customer Information Reception: Our specialists receive customer information and conduct preliminary information exchange (list of documents to prepare for medical equipment classification as mentioned in section 4.2).
– Service Consultation: Specialists discuss the implementation process, provide cost estimates, negotiate, and sign contracts with customers.
– Service Implementation: Specialists check whether the documentation is complete and compliant with Ministry of Health regulations and inform customers of any issues related to the documents for timely supplementation and correction. Subsequently, specialists proceed with the medical equipment classification.
– Return classification results: Customers receive the results of the medical devices classification within 2-3 working days
Please leave complete and accurate information, Medgate will contact you immediately within 24 hours for free consultation and answer your questions.
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