The business of medical equipment and instruments is a special type of business, which is strictly managed and supervised by the state. Individuals and organizations wishing to participate in business activities in this field must ensure that medical equipment and instruments are only allowed to operate when they meet the conditions prescribed by the Ministry of Health.
Medical equipment business is conditional operation but not mandatory for all types of medical equipment. Specifically, for the business of medical equipment of type A is currently unconditional. Enterprises trading in type A medical equipment only need to carry out procedures to publish standards applicable to type A medical equipment before bringing products to the market to be able to conduct business legally.
Particularly for medical equipment of type B, C, D when conducting business establishments, they must carry out procedures to announce sufficient purchase and sale of medical equipment of this type. You will need to meet some of the following requirements:
1.Conditions of the organization performing the classification of medical equipment
– Legally established in accordance with law;
– Someone performs the classification of medical equipment to meet the conditions
+ Have a degree from a university majoring in engineering or majoring in medicine or pharmacy or higher;
+ Have time to work directly on medical equipment techniques at hospitals, medical examination and treatment establishments with hospital beds, specialized training establishments of medical equipment, research establishments on medical equipment, medical equipment manufacturing establishments, to organize the classification of medical equipment and regulatory agencies on medical equipment (hereafter referred to as medical equipment establishments) for 24 months or more;
+ Has been inspected and recognized by the training establishment capable of classifying medical equipment according to the training program issued by the Ministry of Health.
– Establishments may only classify medical equipment after they have been granted a receipt of dossiers of eligibility for classification of medical equipment by the Ministry of Health
2. Dossier of declaration of eligibility for classification of medical equipment
– Written declaration of eligibility for classification of medical equipment by form;
– Form-form personnel declaration; enclosed with a confirmation of the working time according to and the diplomas and certificates of training of each person performing the classification of medical equipment.
– Originals or certified copies for the working time confirmation;
– Certified copies of diplomas and certificates of each person performing the classification of medical equipment.
3. Implementation procedure
Step 1: Before making the purchase and sale of medical equipment of type B, C, D, the head of the medical equipment trading establishment shall send the dossier of declaration of eligibility for sale and sale as prescribed to the Department of Health where the purchase and sale establishment is located;
Step 2: When receiving a complete and valid dossier, the Department of Health shall grant the establishment the publication of the certificate of receipt of the dossier of eligibility for sale and sale.
Step 3: Within 03 working days from the date of receipt of dossiers of notification of eligibility for sale, the Department of Health shall publicize on the portal the following information: Name and address of the medical equipment trading establishment; dossiers of declaration of eligibility for the sale and sale of medical equipment.
Step 4: The establishment may only buy and sell medical equipment of type B, C, D after carrying out the procedure for announcing eligibility for sale as prescribed
Please contact us immediately if you still have questions about the process, procedures or documents to prepare before applying for a license.