Import Medical equipment to Vietnam
With many years of experience in handling importing Medical equipment, in this article, Logistics HP Global summarizes the contents related to importing Medical equipment into Vietnam: Vietnam’s governmental management policy on importing Medical equipment; Import procedures for Medical equipment; Taxes on importing Medical equipment;… …
Definition of Medical Equipment in Vietnam
Definition of Medical equipment was stipulated at Article 2, Decree 36/2016/NĐ-CP dated 15 May 2016 by the Government of Vietnam on Medical Equipment Management, which is amended at Point 1, Article 1 of Decreee 169/2018/NĐ-CP ngày 31/12/2018, as below:
“Medical device” means any instrument, apparatus, material, implant, reagent for in vitro use, software that satisfy all of the following requirements:
a) It is intended by the product owner be used, alone or in combination, for human beings, for one or more of the specific purpose(s) of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury;
– investigation, replacement, modification, or support of the anatomy or of a physiological process;
– supporting or sustaining life;
– control of conception,
– disinfection of medical devices, including chemicals used in testing;
– providing information serving diagnosis, monitoring or treatment through examination of specimens derived from the human body.
b) The device does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. the purposes mentioned in Point a of this Clause.”
HS code of Medical equipment
In order to properly determine policies, procedures of the import, one of the first thing needed to determine is the HS code of the commodity
Trang thiết bị trong lĩnh vực y tế rất đa dạng, HS thuộc nhiều chương khác nhau. Theo quy định tại Thông tư 14/2018/TT-BYT ngày 15 tháng 05 năm 2018 của Bộ Y tế về danh mục trang thiết bị y tế được xác định mã số hàng hóa theo danh mục hàng hóa xuất khẩu, nhập khẩu Việt Nam, mã HS của Thiết bị y tế như sau:
HS code of Medical equipment is very diversified, belong to many chapters. 15 May 2018, Vietnam Ministry of Health issued Circular 14/2018/TT-BYT on Nomenclarure of Medical equipment whose HS codes have been assigned in the Vietnam’s Nomenclature of Exports and Imports as bellow:
|
No. |
Description |
HS codes |
|
1 |
Malaria diagnostic test kits |
3002.11.00 |
|
2 |
Products mixed or unmixed for therapeutic or prophylactic uses (for example, spray or cream used for sores pressure ulcer prevention; sea salt nasal spray; seawater nasal spray; ear spray, oral spray; artificial tears; eye emulsion; gel or solution used for softening and moistening wounds, mouth ulcer gel; kidney dialysis, etc.) |
3004.90.99 |
|
3 |
Adhesive dressings and other articles having an adhesive layer covered or impregnated with pharmaceutical substances |
3005.10.10 |
|
4 |
Adhesive dressings and other articles having an adhesive layer not covered or not impregnated with pharmaceutical substances (for example, antibacterial plasters; fever patches; cooling patches; heat patches, etc.) |
3005.10.90 |
|
5 |
Bandages |
3005.90.10 |
|
6 |
Gauze |
3005.90.20 |
|
7 |
Gamgee |
3005.90.90 |
|
8 |
Sterile absorbable surgical or dental yarns; sterile surgical or dental adhesion barriers and pads, whether or not absorbable |
3006.10.10 |
|
9 |
Sterile non-absorbable surgical or dental yarns, sterile absorbable surgical or dental haemostatics; sterile surgical or dental adhesion barriers, whether or not absorbable; hemostatic materials; surgical elevator; mesh used for hernia repair; biological adhesive; bioabsorbable barrier; sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents. |
3006.10.90 |
|
10 |
Blood-grouping reagents |
3006.20.00 |
|
11 |
Dental cements and other dental fillings |
3006.40.10 |
|
12 |
Bone reconstruction cements |
3006.40.20 |
|
13 |
First-aid boxes and kits; wound care kits; |
3006.50.00 |
|
14 |
Gel preparations designed to be used in human medicine as a lubricant for parts of the body for surgical operations or physical examinations or as a coupling agent between the body and medical instruments (for example, ultrasound gel, vaginal gel; viscoeclastic solution used for phaco-emulsification, etc.) |
3006.70.00 |
|
15 |
Appliances identifiable for ostomy use |
3006.91.00 |
|
16 |
Denture fixative pastes and powders |
3306.10.10 |
|
17 |
Solutions used to soak, clean, rinse and store contact lens |
3307.90.50 |
|
18 |
Medical X-ray films |
3701.10.00 |
|
19 |
X-ray panel detector |
3701.99.90 |
|
20 |
Solutions and chemicals used to sterilize medical instruments and equipment |
3808.94.90 |
|
21 |
– Plates, sheets, film, foil and strip of plastics impregnated or coated with diagnostic reagents |
3822.00.10 |
|
22 |
Paperboard, cellulose wadding and web of cellulose fibres impregnated or coated with diagnostic reagents |
3822.00.20 |
|
23 |
Other diagnostic reagents (for example, test trips, test plate, reagents, in vitro calibration solutions, in vitro control materials, etc.) |
3822.00.90 |
|
24 |
Other articles of plastics (for example, cuvette, conical probes, sterilization tray; transfer sets, lines; post-surgical splints; fixation masks; catheter clamps, circuit; catheter holder adhesive patches; urine drainage bags; bags containing waste fluid from peritoneal filtration; test tube containing antifreeze; sterilization pouches, paperless instrument containers; banded plastic bags; endoscopic camera protective bags; colonoscopic specimens bags, etc.) |
3926.90.39 |
|
25 |
Condoms |
4014.10.00 |
|
26 |
Surgical gloves |
4015.11.00 |
|
27 |
Examination gloves |
4015.19.00 |
|
28 |
Packing containers used for sterilization of medical instruments, in plastic and paper bags (containing more paper), consisting of two sides (plastic coated on one side and paper coated on the reverse side), with 3 edges properly sealed and the fourth edge having an adhesive strip to seal the bag. Put up in packings for retail sale. |
4819.50.00 |
|
29 |
Products used for sterilization of medical instruments, in the form of squeezed tubes, consisting of two sides (paper coated on one side and polyester coated on the reverse side), with 2 edges properly sealed, put up in rolls. |
4823.90.99 |
|
30 |
Stockings for varicose veins, of synthetic fibres |
6115.10.10 |
|
31 |
Surgical gowns |
6211.43.10 |
|
32 |
Compression garments of cotton of a kind used for the treatment of scar tissue and skin grafts |
6212.90.11 |
|
33 |
Compression garments of other textile materials of a kind used for the treatment of scar tissue and skin grafts |
6212.90.91 |
|
34 |
Surgical masks |
6307.90.40 |
|
35 |
Medical or surgical sterilizers (for example, steam sterilizers; low-temperature plasma sterilizers, etc.) |
8419.20.00 |
|
36 |
Centrifuges used for medical diagnosis, testing and screening |
8421.19.90 |
|
37 |
Wheelchairs, wagons and similar vehicles specially designed for disabled persons, whether or not motorized |
8713.10.00 |
|
38 |
Contact lens (nearsightedness, farsightedness, astigmatism) |
9001.30.00 |
|
39 |
Surgical loupes, dermoscopes |
9002.90.90 |
|
40 |
Corrective spectacles |
9004.90.10 |
|
41 |
Surgical miroscopes |
9011.80.00 |
|
42 |
CO2 laser treatment projector |
9013.20.00 |
|
43 |
Electro-cardiographs |
9018.11.00 |
|
44 |
Medical Ultrasonic scanning apparatus (for example, ultrasonic diagnostic scanner; ultrasonic bone densitometer; ultrasonic fetal heart detector, high-intensity ultrasound equipment system for tumor treatment, etc.) |
9018.12.00 |
|
45 |
Magnetic resonance imaging apparatus |
9018.13.00 |
|
46 |
Scintigraphic apparatus |
9018.14.00 |
|
47 |
Patient monitors; bilirubin meters; encephalographs; electro-mechanical machine; endoscopic diagnostic system; respiratory function meter/analyzer; surgical positioning equipment and apparatus for functional exploratory examination or for checking physiological parameters |
9018.19.00 |
|
48 |
Ultra-violet or infra-red ray apparatus |
9018.20.00 |
|
49 |
Disposable syringes |
9018.31.10 |
|
50 |
Electric syringes, infusion pump |
9018.31.90 |
|
51 |
Tubular metal needles and needles for sutures; surgical metal needles; lancing devices and lancets used to obtain blood and body fluids; needles for artificial kidney system; intravenous cannulae |
9018.32.00 |
|
52 |
Urinary catheters |
9018.39.10 |
|
53 |
Catheters, cannulae and the like (for example, catheterization instruments; platelets pooling kits and kits for separating leukocytes; bloodlines; intravenous cannulae used for blood transfusion; stomach tube; feeding tube; blood sampling devices; lines for electric syringes; cannulae, catheters, etc.) |
9018.39.90 |
|
54 |
Dental drill engines, whether or not combined on a single base with other dental equipment |
9018.41.00 |
|
55 |
Other ophthalmic instruments and appliances (for example, automatic refractometer; retinal power meter; retinal scanners/fundus fluorescence scanner; ophthalmologic surgery system (Excimer Laser, Femtosecond Laser, Phaco, vitreous cutter, corneal flap microkeratome); laser treatment machine used for ophthalmology; express Glaucoma filtration device, etc.) |
9018.50.00 |
|
56 |
Intravenous administration sets, vein display instrument |
9018.90.20 |
|
57 |
Electronic instruments and appliances used in medical, surgical or dental sciences (for example, cardiac defibrillators; electric scalpels; ultrasonic scalpels; laser scalpels; anesthesia machine and ventilators; ventilators; infant incubators; lithotripsy system; dialysis equipment; cryosurgery equipment; cardiopulmonary bypass machine; liver filtering machines; hemodialysis machines, peritoneal dialysis machines for patients with renal failure; system of equipment for prostate surgery, etc.) |
9018.90.30 |
|
58 |
Medical equipment and instruments that are classified under the heading 9018 but yet to be included in Vietnam’s nomenclature of exports and imports and nomenclature enclosed with this Circular. |
9018.90.90 |
|
59 |
Orthopaedic or splints and other fracture appliances |
9021.10.00 |
|
60 |
Artificial teeth |
9021.21.00 |
|
61 |
Dental fittings |
9021.29.00 |
|
62 |
Artificial joints |
9021.31.00 |
|
63 |
Other artificial parts of the body |
9021.39.00 |
|
64 |
Hearing aids, excluding parts and accessories |
9021.40.00 |
|
65 |
Pacemakers for stimulating heart muscles, excluding parts and accessories |
9021.50.00 |
|
66 |
other appliances which are worn or carried or implanted in the body, to compensate for a defect or disability (for example, coronary stents; embolization beads, inferior vena cava filters, vascular closure devices; artificial intraocular lens, etc.) |
9021.90.00 |
|
67 |
Computed tomography apparatus |
9022.12.00 |
|
68 |
Diagnostic or therapeutic equipment for dental uses |
9022.13.00 |
|
69 |
Apparatus based on the use of X-rays for diagnosis or treatment, for medical or surgical uses |
9022.14.00 |
|
70 |
Apparatus based on the use of X-rays or of alpha, beta or gamma radiations for medical, surgical or dental uses, including radiography or radiotherapy apparatus (for example, Cobalt machine for cancer treatment, linear accelerator for cancer treatment, gamma scalpels of various kinds, brachytherapy equipment of various kinds, etc.) |
9022.21.00 |
|
71 |
Diagnostic equipment with radioactive isotopes (PET, SPECT, thyroid uptake system I130, I131) |
9022.90.90 |
|
72 |
Electronic thermometers |
9025.19.19 |
|
73 |
Mercury medical thermometers |
9025.19.20 |
|
74 |
Electrically operated apparatus for physical or chemical analysis for medical uses (for example, biochemical analyzers; electrolyte and blood gas analyzers; hematology analyzers; coagulation meters; erythrocyte sedimentation rate meters; Elisa test system; blood group analyzers; cell extraction units; platelet aggregation and functional analysis meters; bacteria and virus identifiers; immunological analyzers; bacterial and viral load monitoring devices; blood glucose meters, etc.) |
9027.80.30 |
|
75 |
Dentists’ chairs and parts thereof |
9402.10.10 |
|
76 |
Furniture specially designed for medical or surgical purposes (for example, electronically controlled hospital beds; operating tables; emergency beds, resuscitative beds; hospital bedside cabinets; specialized emergency carts; blood collection chairs; transfusion chairs, etc.) |
9402.90.10 |
|
77 |
Commodes |
9402.90.20 |
|
78 |
Ceiling operating lamps |
9405.10.20 |
|
79 |
Table or bed operating lamps |
9405.20.10 |
|
80 |
Examination lamps |
9405.20.90 |
|
81 |
Surgical lamps |
9405.40.91 |
The classification of a product to a certain HS code is based on the nature, composition, …. of the actual imported commodity at the import time, based on catalogue, technical documents (if any) or /and decided by the Customs Department of Commodity Verification. The actual inspection results of the Customs and announcement by the Customs Department of Commodity Verification are legal basis for applying HS code to imported good. Importers are ultimately responsible for ensuring that the products are correctly classified.
Our above advised HS codes are for reference only.
For more information about this content, please refer to the article Definition of HS code in Vietnam
Ban on import, export
According to the current regulation, new Medical equipment is not in the List of prohibited imports into Vietnam, so the enterprise can do the import procedure pursuant to current stipulations.
However used medical equipment is in the List of prohibited imports into Vietnam.
For more information, read the article List of prohibited imports into Vietnam
Import procedure to Vietnam of Medical equipment
Governmental management on Medical equipment
Medical equipment items under the specialized management of the Ministry of Health. When importing enterprises must classify medical equipment and must have receipt of dossiers of announcement of eligibility for classification of medical equipment for customs procedures.
And in the case of medical equipment with HS codes on the list of medical equipment subject to import licenses (According to Circular No. 14/2018 / TT-BYT dated May 15, 2018 and Circular 30/2015/ TT-BYT), when importing medical equipment, when importing, must apply for import license.
Customs procedure of import Medical equipment into Vietnam
According to Decree 36/2016 / ND-CP on management of medical equipment, businesses need to prepare:
-The usual set of documents when importing goods
-Import license (if the item has HS code of Circular 14/2018 / TT-BYT)
-Business certificate or investment certificate
-The certificate of ISO 13485 or ISO 9001 international quality management standard is valid and the validity period of the manufacturer or manufacturer of the imported medical equipment.
-Certificate of free circulation for imported medical equipment and CFS products
-Authorization letter
– Product description catalog
-Technical document describing imported medical equipment and products in Vietnamese (Appendix 4)
– Results of clinical trial evaluation of medical equipment applied for import
=> Records published
-Classification paper
– Number of the receipt of application file (type A) or number of certificate of registration of circulation (B, C, D)
Label for import Medical equipment
According to current stipulation, cargo imported into Vietnam need to have sufficient label
Customs Duties on importing Medical equipment
When importing Medical equipment, the importer needs to pay import duties and value added tax (VAT).
VAT on Medical equipment: 5%.
Preferential import tax rate on Medical equipment is 0% ( depending on HS code).
Shipping Cost and time for importing Medical equipment
Shipping costs and transportation time are closely related. Depending on the nature of the commodity and requirement of the shipment, the commodities could be transported by sea, air, road, rail and express delivery. The enterprise should consider to make the most appropriate decision.
For more detailed advice on import procedures, shipping methods and estimate for the full shipping cost, please contact us – Service Provider for exporting Medical equipment
Hp Global Company Limited
Freight forwarder and Customs Brokerage
Room 2308, CT2 Van Khe, La Khe, Ha Dong, Hanoi
Website: hpgloballtd.com/hptoancau.com
Email: info@hpgloballtd.com
Phone: 024 73008608 / Hotline: ++84 8 8611 5726
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