Let us have a chance to show your company a 2023 Guideline of How to Import Medical devices into Vietnam.
First step is to do Business registration.
Secondly, Medical device classification, which is an important basis for carrying out further procedures, must be done by Importer according to Circular 05/2022/TT-BYT and Decree 98/2021/ND-CP. Medical devices in Vietnam are divided into 4 levels of risk: A, B, C and D. Due to the fact that not all partners can do classification correctly, we are here to help.
For low risk levels, class A and B, Importer must have the number of declarations of applied standards of Class-A or Class-B medical devices. It takes 3 to 10 work days for this declaration to be approved by the Health Department of provinces and cities.
Class A medical devices can be named such as medical masks, medical gloves, medical beds, wheelchairs, surgical kits (forceps, tweezers, cotton swabs), etc.
Some Class B medical devices include braces, blood pressure monitors, pregnancy test strips, ultrasound machines, dental chairs, breast pumps, etc.
It is required a longer time to import devices on higher risk levels which are listed in Article 06, Circular 05/2022/TT-BYT. An application for registration number for the medical device must be issued by the Ministry of Health.
Other Class C and D devices such as pulse oximeter, condom, sterilizer, etc which are excluded from Article 06, Circular 05/2022/TT-BYT can be imported by having only classification results.
The declaration of applied standards, the Circulation and the Classification will not be expired unless there is a notice to amend Decree 98/2021/ND-CP.
Last step is to do an Import customs declaration. A set of dossiers for carrying out import customs procedures includes: