Service on Registration for Circulation of Medical Equipment and Facilities

To prevent illegal import of medical equipment from other countries without publication of free sales, the Ministry of Health has issued certain policies to govern the process of registration for circulation of medical equipment and facilities. According to Circular No: 07/2002/TT-BYT Guiding the registration for circulation of medical equipment and facilities, Ha Le Consultancy will guide customer on requesting certificate of free sales.

Service Description

The dossiers of registration for circulation of domestically produced medical equipment and facilities include: 

• The application for circulation registration of medical equipment and facilities.
• The business registration certificate (notarized copy), which inscribes the function of producing medical equipment and facilities.
• The announcement of goods quality standards or the announcement of goods compatibility with standards.
• The results of tests conducted in at least 03 Vietnamese medical establishments (depending on each type of product, the Ministry of Health shall designate medical establishments to conduct the tests).
• The results of testing on chemical and physical properties as well as the results of safety expertise by functional bodies (for types of products requiring testing and/or expertise).
• Technical documents and use instructions.
• The products labels: In strict accordance with the Regulation on the labeling of goods to be circulated in the country as well as export and import goods, issued together with the Prime Minister’s Decision No. 178/1999/QD-TTg of August 30, 1999 and Circular No. 34/1999/TT-BTM of December 15, 1999 of the Ministry of Trade guiding the implementation thereof.

Notice: The circulation registration numbers shall be valid for three years as from the issuance date. Thirty days before the expiry date, if the units continue trading in and/or producing products which have already been granted circulation registration numbers, they shall have to carry out procedures for extension. During the permitted circulation period, if the producers make any changes in the products models or technical properties, they shall have to send written reports thereon to the Ministry of Health.

The Values Ha Le provides

• Facilitate and support the devices to work corresponding to its purpose and intention.
• Provide medical equipment with its own name or with any label, design, trademark, or other names and codes owned by or under control of individuals/owners of enterprises.

Documents should be prepared by customers:

• The application for circulation registration of medical equipment and facilities.
• The business registration certificate (notarized copy)
• Test report on components and active ingredients
• Test report on biological effects
• Letter of Authorization from Manufacturer and Certificate of Free Sales (for imported products)
• Certificate of Environmental Compliance (for local products)

Please contact for further consultancy and detailed quotation!