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Opening a business store selling medical devices requires compliance with legal regulations, as medical devices directly affect human health and life. Therefore, business activities in this field are strictly regulated by the state and relevant authorities.
What are the conditions for opening a medical devices business? What is the documentation and registration process for Medical Devices? To help you understand the business conditions, as well as the sequence, procedures, and documentation for medical device business to proactively comply with legal requirements, Medgate provides you with the following article
Conditions for Circulating Medical Devices
(According to Article 22, Decree No. 98/2021/ND-CP on the Management of Medical Devices)
a) Medical devices must have a registered circulation number or an import license as stipulated in Decree No. 98/2021/ND-CP.
b) Medical devices must have labels with all required information according to current legal regulations on product labeling.
c) Medical devices must have user instructions in Vietnamese.
d) Medical devices must provide information on warranty terms, conditions, and duration (except in cases where the medical device is for one-time use according to the owner’s regulations or has documentation proving the absence of a warranty).
Note: In cases where there is no information on user instructions or warranty terms, the entity must provide this information electronically and clearly indicate how to look up information on the medical device label.
Classification of Medical Devices
Medical Devices is classified into 4 class based on the level of potential risks related to the technical design and production of such medical device:
|
Class |
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 |
(Based on Decree No. 98/2021/ND-CP on the management of medical devices, the facility listed as the declarant of standards or registered for circulation is responsible for classification and publicly disclosing the classification on the Ministry of Health’s online public service website.)
Conditions for the Physical Facility of Medical Device Business
When opening a medical device business store, the store must meet the following conditions:
– The store must have an area suitable for the requirements of the type of medical device it sells.
– It must have equipment and a quality control process for the medical device types, or the medical devices must be quality-checked by a facility capable of testing medical device quality.
– The store must have a warehouse for storing medical device and must meet the following minimum conditions:
- The warehouse must have an area suitable for the quantity and types of medical device to be stored.
- The warehouse must ensure dryness, cleanliness, ventilation, and must not be close to sources of pollution.
- The warehouse must meet other requirements for storing medical device according to the instructions for use.
– It must have suitable transportation from the trading facility to the delivery location.
– The medical device business store must implement a quality management system according to current regulations.
– If the medical device business does not have a warehouse and transportation, it must have a contract with a capable entity that meets the requirements for a warehouse and transportation of medical devices as stipulated.
Procedures for Opening a Medical Device Business
The procedures for opening a medical device business store are stipulated as follows:
– The representative of the store needs to submit a Request for Registration of the medical device business to the authorized business registration agency in the district/ward where the store is located.
– Attached to the Request for Registration of the medical device business are copies of the identity cards and passports of all individuals involved in opening the store or the representative of the store. In the case of opening a store with the participation of a group of individuals, meeting minutes are required. Additionally, professional certificates of each individual or the representative of the store must be provided.
– Within 5 working days from the date of receiving the application, the receiving agency will issue a Certificate of Business Registration for the medical device business. In case the application is incomplete or invalid, the store owner will receive a notice from the agency regarding the necessary adjustments and additions to the application.
To receive consultation on document services, registration procedures of medical device, please contact Hotline: 098.546.1894