Are you looking for information on the regulations and legal procedures for importing medical device into Vietnam? Vietnam has strict regulations on importing medical device to ensure quality and safety for users. Therefore, this process requires careful preparation and strict compliance with legal regulations. This article will provide you with the necessary information to successfully complete the procedures for importing medical device into Vietnam.
What are the conditions for importing medical device into Vietnam?
Medical devices in circulation on the market must meet the following conditions:
- Have a circulation number or import license as prescribed, except in special cases;
- Have a label with full information as prescribed by law on product labels;
- Have a medical device instruction sheet in Vietnamese;
- Have information on the warranty facility, conditions and warranty period, except in the case of medical devices used once as prescribed or have documents proving that there is no warranty.
What are the procedures for importing medical device into Vietnam?
Below are the necessary procedures to import medical device into Vietnam:
Step 1. Classification of medical devices
First, you need to determine what type of medical device your product is to perform the most accurate procedures. According to Vietnamese law, medical devices are divided into 4 types. This classification is based on the potential risk level of medical devices, in which type A is the lowest risk, type D is the highest risk, including:
- Medical devices in type A are medical devices with a low risk level. For example: bandages, rubber gloves, walkers, syringes, medical masks, non-electronic thermometers…
- Medical devices in type B are medical devices with a low-medium risk level. For example: ENT endoscopes, pregnancy test strips, hearing aids, ceramic blanks for dentures…
- Medical devices in type C are medical devices with a high-medium risk level. For example: ultrasound machine, ventilator, automatic blood pressure monitor, blood glucose meter…
- Medical equipment of type D is medical equipment with high risk level. For example: endoscopic surgery machine, surgical laser machine, magnetic resonance imaging (MRI) machine, radiotherapy machine…
See more: Classification of medical devices according to the Vietnamese Ministry of Health
Step 2. Announcement of applicable standards for medical devices
1. Medical device type A, B
Next, if your product is a type A or B medical device, you need to complete a declaration of applicable standards including the following documents:
- Document declaring applicable standards of type A or B medical devices.
- Certificate of compliance with ISO 13485 quality management standards (still valid).
- Authorization letter in case of authorizing another individual or organization to carry out the procedure.
- Certificate of eligibility for warranty, except for single-use medical devices or documents proving that there is no warranty.
- Document summarizing the technical description of the medical device in Vietnamese. It is necessary to attach a technical document describing the functions and technical parameters of the medical device issued by the owner of the medical device.
- Certificate of conformity according to regulations or product standards published by the owner of the medical equipment.
- Instructions for use of the medical equipment.
- Sample labels to be used when circulating in Vietnam of the medical device.
- Certificate of free circulation valid at the time of application submission for imported medical device.
2. Medical device of type C,D
If you import medical device into Vietnam and the device is of type C, D, the dossier for declaring the applicable standards will include the following documents:
- Application for circulation registration (according to the form).
- Certificate of free circulation (CFS) of the product in the country of manufacture.
- Authorization letter from the manufacturer or product owner for the registration unit in Vietnam.
- Certificate of quality management system (ISO 13485 or equivalent).
- Classification of medical device.
- Technical documents describing the product (including information on structure, operating principles, indications for use, contraindications, etc.).
- Product label.
- Documents on manufacturing and storage conditions.
- Test results or clinical evaluation reports (if any).
- Documents proving the safety and effectiveness of the medical device.
Applications will be submitted to the Vietnam Ministry of Health and processed within 45 working days depending on the type of device.
Step 3. Apply for a medical device import license
Application for import license of medical device into Vietnam:
- Application for import license.
- Medical edevice classification.
- Product registration certificate or equivalent document.
- Sales contract, commercial invoice, packing list.
- Bill of Lading.
Application submitted to the Department of Medical Equipment and Construction Management, processing time is about 15 working days from the date of receiving complete and valid documents.
Step 4. Check and clear customs for importing medical equipment into Vietnam
- The inspection dossier includes:
- Import license for medical devices into Vietnam.
- Relevant documents such as customs declaration, sales contract, invoice, and packing list.
- Customs clearance: Carry out customs clearance procedures at the Vietnamese customs authority.
Important note:
- Most medical devices in group A do not require an import license but only need to declare the applicable standards.
- Devices in groups B, C, and D may require an import license, in addition to registration for circulation.
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