Medical Devices

Regulations on importing medical devices

Currently, the state encourages domestic enterprises to produce medical devices for export. However, the increasing demand for medical devices in medical examination, treatment, and health care shows the necessity of importing medical devices. In this article, let’s learn about the regulations on importing medical devices with MEDGATE

Conditions for Organizations and Individuals Implementing Imported Medical Devices

Imported medical devices must comply with the regulations set forth by the law on export and import. Additionally, the importer is responsible for ensuring the quality, quantity, type, and intended use of these medical devices. Here are some requirements for organizations and individuals involved in importing: 

  1. They must either own the circulation number or possess a power of attorney from the owner of that circulation number. 
  2. They should have a warehouse and transportation means that meet specific requirements, or they must be partnered with a facility that has sufficient capacity to manage and operate medical devices. 
  3. They need to have a storage warehouse and a monitoring system in place to manage the export, import, and inventory of medical devices, especially those containing narcotics and precursors, in compliance with applicable regulations. Accordingly, the ordering and procedures for importing medical devices must follow the provisions detailed in customs law.

License for Importing Medical Devices

A medical device that has a registration number for circulation in Vietnam can be imported without quantity restrictions or prior approval from the Ministry of Health. However, medical devices lacking a circulation number requires an import license for the following purposes: 

  1. Scientific research, inspection, testing, trials, quality assessments, or training on the use and repair of medical devices. 
  2. Meeting urgent needs. 
  3. Humanitarian aid, gifts, or donations for medical facilities, as well as for fairs, exhibitions, or product introductions. 
  4. Humanitarian medical examination and treatment activities.
  5. Personal medical treatment purposes, including personal medical devices or devices required for special diagnostic needs of medical facilities. 
  6. Imported used medical devices intended for research and training purposes (not for human use, diagnostics, or treatment).

For further information on the process of applying for an import license for medical devices and the list of medical devices that has been granted an import license, please refer to Article 6 of Circular 05/2022/TT-BYT and visit: https://medgate.vn/en/service-fee-for-applying-for-medical-devices-import-license/

Requirements for Certificate of Free Sale (CFS) for Imported Medical Devices

The importation of medical devices is regulated by the Ministry of Health. Consequently, the importer must submit a Certificate of Free Sale (CFS) that corresponds to the specific code of the goods. The CFS for imported medical devices must include, at a minimum, the following information: 

  1. Name of the issuing agency or organization 
  2. CFS issuance number and dat
  3. Product name for which the CFS is issued 
  4. Type or category of the product or goods
  5. Name and address of the manufacturer
  6. A clear statement indicating that the product or goods are manufactured and authorized for free sale within the market of the country of manufacture or the country that issues the CFS. 
  7. Full name and signature of the individual signing the CFS, along with the seal of the issuing agency or organization. 

The CFS must be consular legalized unless exemptions are provided by international treaties to which Vietnam is a party, or based on reciprocity. 

 

For more information about medical equipment registration services and the process of obtaining medical devices circulation numbers at MEDGATE, please contact our hotline at 098.546.1894 or email us at medgatevn@gmail.com. We are ready to provide guidance on documentation, procedures, and cost estimates for registration, circulation announcements, and advertising of medical devices.