Medical Devices

NOTES ON DECLARING ELIGIBILITY FOR MEDICAL DEVICE TECHNICAL CONSULTING SERVICES

In the context of the healthcare sector’s ongoing modernization, medical devices are becoming increasingly sophisticated, requiring a high level of technical expertise for consulting, installation, and operation. Therefore, strict control over the quality of technical consulting is essential to ensure safety in medical examination and treatment.

To legally provide medical device technical consulting services, individuals and organizations are required to declare their eligibility with the Ministry of Health. The following information outlines the conditions, documentation, procedures, and key notes to help you prepare properly for this declaration process:

WHAT IS A DECLARATION OF ELIGIBILITY FOR TECHNICAL CONSULTING?

This is a mandatory administrative procedure for any organization or enterprise intending to provide technical consulting services related to medical devices. The declaration demonstrates transparency in professional capacity and serves as a legal basis for lawful operation in the market.

WHO MUST CARRY OUT THIS PROCEDURE?

Applicable to businesses and organizations intending to provide services such as:

  • Preparing medical device lists
  • Consulting on device configurations and technical specifications
  • Guiding deployment and maintenance of devices in healthcare facilities

MANDATORY ELIGIBILITY REQUIREMENTS

According to Article 53 of Decree No. 98/2021/NĐ-CP, technical consultants must:

  • Hold a university degree or higher in engineering, medicine, or pharmacy
  • Have at least 5 years of relevant experience in medical device technical work at healthcare facilities
  • Complete an official training program on medical device technical consulting issued by the Ministry of Health and obtain a certificate of consulting competence

REQUIRED DOCUMENTS

A complete application dossier includes:

  • Declaration of eligibility to provide medical device technical consulting (Form No. 06 under Circular 19/2021/TT-BYT)
  • Certified copies of academic degrees and professional certificates
  • Proof of work experience at a healthcare facility (as per prescribed form)

Proof of payment for the appraisal fee of VND 3,000,000, in accordance with Circular 278/2016/TT-BTC

PROCEDURE

The declaration process consists of two main steps:

Step 1: Online Submission
 Submit the application via one of the following portals:

Step 2: Information Disclosure
 Upon receipt of a valid dossier and fee, the Ministry of Health will review and publicly list eligible individuals on the official portal to authorize consulting activities.

PROCESSING TIME AND RESULT

  • Processing time: Within 1 working day upon receipt of a complete and valid application
  • Result: The list of eligible consultants will be published on [dmec.moh.gov.vn] under the “Public Service Results” section for easy reference by healthcare partners

HOW TO VERIFY ELIGIBLE INDIVIDUALS

To verify the list of certified consultants:

  1. Visit https://imda.moh.gov.vn
  2. Select the “Public Service Results” section
  3. Enter the keyword “TVKT” (short for Technical Consulting)
  4. Click “Search” to view the official list

IMPORTANT NOTES

  • Only individuals officially declared eligible may engage in consulting services
  • Providing consulting services without a declaration may result in legal penalties
  • Any changes in personnel or consulting scope must be updated with a new declaration

Vietnam’s medical device market is expanding rapidly, increasing the demand for accurate and professional technical consulting. To operate legally and build long-term credibility, declaring eligibility is a critical and non-negotiable step.

📞 For support on registration procedures for medical devices, health supplements, cosmetics, or related regulatory services, contact us at Hotline: 098.546.1894 or message us directly via our fanpage.