Requirements for Free Sale of Medical Equipment in Vietnam

Requirements for Free Sale of Medical Equipment in Vietnam

Article 17, Decree 36/2016/NĐ-CP: "Medical Equipment Management" dated May 15, 2016 states:

1)Any medical equipment to be freely sold must satisfy the following requirements:

a) Must have an effective free-sale registration number, or obtain a permission to import according to the provisions of this Decree.

**Free-sale registration number of medical equipment means:

- The number of the receipt note of the Declaration of Applicable Standard for Type A medical equipment. 

- The number of the Certificate of Registration of Free Sale for Types B, C and D medical equipment.

**The registration number of free sale of medical equipment may be issued to one type or a group of medical equipment types.

**The holder of the free-sale registration number is the organization declaring the applicable standards for Type A medical equipment or the organization obtaining the free-sale registration number for type B, C or D medical equipment.

** Validity of the free-sale registration number:

- The registration number of free sale certificate of Type A medical equipment shall be permanently valid.

- The registration number of free sale certificate of Types B, C and D medical equipment shall be effective for 05 years from the date of issue. In case the validity of the registration number is extended, the registration number shall be retained.

** The import license (permission to import) is applied to medical equipment that do not have the free-sale registration number and is imported for scientific research; as adjunct to the use of medical equipment, such as for testing, repair, or medical device aids; or medical devices for personal use.

b) Must have a label or supplementary label containing sufficiently information as specified in Article 54 of this Decree.

** The mandatory content of a medical device label includes:

- Name of the medical equipment;

- The registration number of the free sale certificate;

- Name and address of the holder of the registration number;

- The origin of the medical equipment;

- Date of production and expiry date. The date of production and the expiry date must be written in the format [dd/mm/yyyy] or [mm/yyyy];

- Batch number or serial number;

- Information about the warranty provider
- Guidelines on how to use the medical equipment
- Documents needed for repair services and maintenance, according to regulations.

** Medical equipment imported into Vietnam whose label does not contain the information mentioned above must be enclosed with a supplementary label containing such information, written in Vietnamese, together the original label of the equipment.

c) Must have technical documents for repair services and maintenance of medical equipment.  Disposable medical equipment are exempted from this requirement.

d) Must have a Vietnamese instruction on how to use the medical equipment.

e) Must have information on warranty establishments, conditions of the warranty, and its duration, unless the equipment is disposable.

2. If the information specified in paragraphs c, d and e of this Article are not provided with the equipment, it should at least be available electronically, and the guidelines for accessing such information must be clearly stated on the label of the medical equipment.



Edited by: Jean Ngo