Question:

A Company intends to import medical equipment for distribution in Vietnam. The company would like to know about regulations on importing and trading of medical equipment.

Our advice:

Thank you so much for trusting and sending the mentioned-above question to Bizlawyer & Partners. We would like to present a few points on conditions for importing and trading of medical equipment as follows:

1. Regulations on importing medical equipment

According to article 3, Circular No. 30/2015/TT-BYT, medical equipment importation must be laid down behind the following principles:

– The importer must obtain an import permit if the medical equipment imported is listed in Annex 1 of the Circular.

– The medical equipment not included in the List specified in Annex 1 issued with Circular No. 30/2015/TT-BYT shall be imported without the import Permit but must still ensure the dossier to trace their origin and quality management of medical equipment as prescribed by law.

Note:

– The medical equipment imported must be new

– The validity the import permit is up to 01 year from the date of signature and issue.

2. Regulations on trading imported medical equipment

2.1. Classification of medical equipment

Medical equipment shall be classified into 2 groups which depending on the possible levels of risks related to the design and production of such medical equipment.

According to Article 4, Decree No. 36/2016/NĐ-CP, medical equipment shall be classified into 2 groups:

• Group 1 comprises of medical equipment typed ‘A’ which under low level of risks.
• Group 2 comprises of medical equipment typed ‘B’, ‘C’ and ‘D’, which are under lower average, upper average and high level of risks, respectively.

The classification of medical equipment must be conducted by an organization satisfying conditions of law.

2.2. Regulations on free sale of medical equipment

– Any medical equipment can be freely sold after the importer carries out the procedures for declaration of standards or registration of free sale applicable to the medical equipment imported

– According to article 18 of Decree No. 36/2016/NĐ-CP, the medical equipment imported ‘shall be manufactured at an establishment which has been issued with a Certificate of conformity of quality management and shall be freely sold in any country in the world’, which is a mandatory requirement for declaration of standards or registration of free sale

– Declaration of standards is applicable to medical equipment typed ‘A’

– Registration of free sales is applicable to medical equipment typed ‘B’, ‘C’ and ‘D’

2.3. Requirements for medical equipment trading establishments

According to article 37 of Decree No. 36/2016/ND-CP and article 23.1 of Decree No. 169/2018/ND-CP, an establishment of trading medical equipment typed ‘B’, ‘C’, ‘D’ must eligible for the following conditions

1) Having at least 01 employee who has a college or higher degree in technology, health, pharmacy or medical devices or other majors suitable for the medical equipment for sales; and

2) Having at least a warehouse and a vehicle that satisfy the following requirements:

a. The warehouse must

• have an area suitable for the categories and quantities of medical equipment stored therein;
• be airy, dry and clean, and separated from sources of pollution;
• satisfy storage conditions of the medical equipment according to their instructions manuals.

b. The vehicle for the delivery of medical equipment is suitable for the equipment.

An establishment without a warehouse or vehicle may sign a contract with a qualified storage or transport service provider

3) Requirements for trading in medical equipment that contain narcotic substances or precursors

a. The chief technician has a bachelor’s degree in medical devices, health, pharmacy, chemistry or biology;

b. There is a warehouse that satisfies the requirements specified in Article 7 of Decree No. 80/2001/ND-CP; and

c. There is an inventory monitoring system for medical devices containing narcotic substances and precursors.

Note: Before trading medical equipment typed ‘B’, ‘C’, or ‘D’, the head of the establishment shall apply for a declaration of eligibility to trade medical equipment at the Department of Health where the establishment is located.

Conclusion:

Hopefully, the information contained in this article is useful to you. If you still have any question relating to import permit for medical equipment, please contact us directly via our email: Info@bizlawyer.vn or Hotline Call: 086.888.1900 for timely advice and support.