Medgate is a company that provides a variety of services such as product registration, professional training, import, export and distribution of products (health supplement, cosmetics, medical devices, pharmaceuticals).

Medical Devices Import Services: Medical Devices intended for import and circulation in the Vietnamese market must undergo numerous procedures. To understand more about the procedures and the process of importing medical devices, read the following article by Medgate.

Legal Basis:

• Decree No. 98/2021/ND-CP issued on November 8, 2021: On the management of medical devices.
• Decree No. 07/2023/ND-CP issued on March 3, 2023: Amending and supplementing some provisions of Decree No. 98/2021/ND-CP dated November 8, 2021, by the Government on the management of medical devices.

Cases Requiring Import Licenses:

1. a) Medical Devices without circulation numbers for research purposes, scientific experimentation, testing, quality assessment, examination, user training, or repair of medical devices.
2. b) Medical Devices without circulation numbers imported for epidemic prevention, disaster relief, and mitigating the consequences of natural disasters.
3. c) Medical Devices without circulation numbers imported for humanitarian assistance; gifts for healthcare facilities; serving fairs, exhibitions, displays, or product introductions.
4. d) Medical Devices without circulation numbers imported for humanitarian medical examination and treatment activities.
5. e) Medical Devices without circulation numbers imported for personal medical treatment.
6. f) Medical Devices without circulation numbers imported for use in healthcare facilities purchased from official development assistance funds (ODA) and preferential loans, non-refundable aid not covered by official development assistance.

Medical Devices Import Procedures

Product Classification: Classify products into class A, B, C, D.

Declaration Standards of Medical Devices:

• For Medical Devices in class A, B: Standards Declaration.
• For Medical Devices in class C, D: Register for circulation.

Application for Medical Devices Import License:

1. a) Document requesting import license
2. b) Document describing a summary of technical specifications for Medical Devices (in Vietnamese).
3. c) ISO 13485 certification.
4. d) For research imports: Include a certified copy of the research project approval and documentation proving Medical Devices has been granted circulation approval (with confirmation from the company requesting import license ).
5. e) For training imports: Include the original training program and documentation proving Medical Devices has been granted circulation approval (with confirmation from the company requesting import license ).
6. f) For inspection, testing, quality evaluation imports: Include a confirmation document from the authorized entity responsible for inspection, testing, quality evaluation (specifying quantity).
7. g) For aid imports: Include a certified copy of the aid acceptance approval from the authorized agency and documentation proving Medical Devices has been granted circulation approval (with confirmation from the company requesting import license ).
8. h) For gifts to healthcare facilities: Include a certified copy of the content for gifting, and documentation proving Medical Devices has been granted circulation approval.
9. i) For medical treatment imports: Include documentation proving Medical Devices has been granted circulation approval (with confirmation from the company requesting import license) and a copy of the doctor’s prescription.
10. k) For special diagnostic needs of healthcare facilities: Include documentation proving Medical Devices has been granted circulation approval (with confirmation from the company requesting import license).
11. l) For personal medical treatment imports: Include a certified copy of the doctor’s prescription.
12. m) For exhibition or product introduction imports: Include copies of the program, invitation, and implementation contract.
13. n) For epidemic prevention and disaster relief imports: Include approval documents from the authorized agency for urgent needs and documentation proving Medical Devices has been granted circulation or emergency use approval (with confirmation from the company requesting import license).

Customs Import Documentation for Medical Devices:

1. a) Commercial Invoice
2. b) Bill of Lading
3. c) Certificate of Origin
4. d) Packing List
5. e) Business Registration Certificate
6. f) Product Circulation License
7. g) Certificate of Analysis (COA)
8. h) Classification of Medical devices and product standard declaration Certificate for Medical Devices A, B
9. i) Classification of Medical Devices and acknowledgment form for product circulation registration for Medical devices class C, D.

Contact Medgate for Procedure Consultation and Service Quotes:

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Website: https://medgate.vn/

Hotline: 098.546.1894

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