Trading Class B C D Medical Devices: Procedure

The procedure for trading Class B C D medical devices requires an announcement of eligibility. This is a critical administrative procedure to ensure medical device business activities comply with regulations, safety, and efficiency. Strict compliance is legally mandatory and enhances the facility’s quality and reputation in the medical device trading sector.

Administrative Procedure Requirements and Conditions

Before a trading facility completes the procedure to announce eligibility for trading Class B C D medical devices, it must meet the conditions stipulated in Article 40 of Decree 98/2021/NĐ-CP dated November 8, 2021:

• Possess at least one (1) technical staff member with:
  • A college degree (or higher) in engineering, medicine, pharmacy, chemistry, or biology; OR
  • A college degree (or higher) in medical equipment technology; OR
  • A college degree (or higher) in a major relevant to the type of medical device the facility trades.
• Possess storage facilities and transportation methods that meet the following minimum conditions:
  • Storage Warehouse:
    • Adequate area for the type and quantity of medical devices stored.
    • Ensures ventilation, dryness, cleanliness, and is not near pollution sources.
    • Meets other preservation requirements as per the medical device’s instructions for use.
  • Transport Vehicle:
    • Transportation for medical devices from the trading facility to the delivery location must be suitable for the type of medical device.
  • If no warehouse or transport exists, a contract with a capable service provider for storage and transport is required.
• For facilities trading medical devices containing narcotics and precursors:
  • The technically responsible person must hold a university degree in medical equipment, medicine, pharmacy, pharmaceutical chemistry, or biology.
  • Possess a storage warehouse that meets legal regulations.
  • Maintain a tracking system to manage the import, export, and inventory of medical devices containing narcotics and precursors.

Administrative Procedure Resolution Agency

According to Item II.12 of the List of administrative procedures issued with Decision 2495/QĐ-BYT dated August 4, 2025, the specialized medical agency under the provincial People’s Committee—the Department of Health—has the authority to resolve the procedure for announcing eligibility for trading Class B C D medical devices.

Procedure for Announcing Eligibility for Trading Class B C D Medical Devices

Understanding this procedure helps facilities execute it quickly and effectively, mitigating legal risks.

Dossier Composition

The dossier composition is regulated in Clause 1, Article 41 of Decree 98/2021/NĐ-CP. One (1) set of the declaration dossier includes the following documents:

• A written announcement of eligibility for medical device trading.
• A personnel declaration.
• Documents proving storage facilities and transport methods for medical devices (Note: These documents must be certified by the facility announcing eligibility).
• Documents proving storage facilities and the import/export/inventory tracking system for medical devices containing narcotics and precursors (Note: These documents must be certified by the facility).

>>> CLICK TO DOWNLOAD:

• WRITTEN ANNOUNCEMENT OF ELIGIBILITY FOR TRADING MEDICAL DEVICES
• PERSONNEL DECLARATION

>>> See more at: Pharmaceutical Business Certificate Adjustment Re-issuance Procedure

Implementation Sequence

The implementation sequence is regulated in Clause 2, Article 41 of Decree 98/2021/NĐ-CP.

• Step 1: Dossier Submission
  • Before trading medical devices, the facility must submit the declaration dossier to the Department of Health where the trading location is registered.
• Step 2: Public Posting on Electronic Portal
  • Upon receiving the complete dossier (including fee payment confirmation as required by the Ministry of Finance), the Department of Health will publicly post the information and the declaration dossier on the medical device management electronic portal.
• During operation, the trading facility must prepare a written notification of any changes, attach relevant documents, and update these documents in the publicly posted declaration dossier on the portal within 03 working days from the date of the change.

>>> See more at: Conditions for establishing a medical equipment trading company

Fees and Charges

According to Item II.12 of the List of administrative procedures issued with Decision 2495/QĐ-BYT, the fees for the procedure are:

• From July 1, 2025, to December 31, 2026: 1,500,000 VND.
• From January 1, 2027, onwards: 3,000,000 VND.

Consulting and Authorization Services by Long Phan Consulting

Long Phan Consulting provides comprehensive services for the procedure of announcing eligibility for trading Class B C D medical devices. Service contents include:

• Analyze and assess compliance with eligibility conditions.
• Advise on dossier composition and procedure.
• Advise on potential financial obligations and taxes.
• Provide detailed guidance on the implementation process.
• Review the legality of documents and evidence submitted to the competent authority.
• Draft and prepare all necessary dossier components.
• Act as the Client’s authorized representative to submit the dossier and monitor processing at the competent authority.
• Receive and deliver results, explaining the contents to the Client as needed.

With a professional and dedicated team, Long Phan Consulting commits to helping Clients complete the procedure for announcing eligibility for trading Class B C D medical devices correctly, in accordance with regulations, and efficiently.

>>> See more at: Chemical Advertising Content Certificate: Steps

Frequently Asked Questions (FAQ)

Long Phan Consulting provides answers to common questions regarding this procedure.

Which Class B C D medical devices are traded as normal goods?

The following Class B, C, D medical devices are traded as normal goods:

• Personal blood pressure monitors.
• Personal pulse oximeters (SpO2) (finger-clip, battery-operated type).
• Infant nasal aspirators.
• Electronic thermometers, infrared thermometers.
• Medical devices used for personal blood glucose measurement: glucose meters, lancing devices, test strips, lancets, control solutions.
• Nebulizers.
• Personal medical bandages and gauze.
• Artificial tears classified as medical devices.
• Condoms.
• Contraceptive diaphragms (non-medicated).
• Vaginal lubricants classified as medical devices.
• Electric hot/cold packs.
• Class B in-vitro diagnostic medical devices for self-testing.
• In-vitro diagnostic medical devices for self-testing for HIV, SARS-CoV-2.

Legal Basis: Article 4, Circular 05/2022/TT-BYT (August 1, 2022).

How are medical devices defined?

Medical devices are devices, implants, instruments, materials, in-vitro reagents and calibrators, or software that simultaneously meet the following requirements:

• Used individually or in combination for humans for one or more purposes:
  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease or compensation for injury.
  • Inspection, replacement, modification, or support of anatomy or physiological processes.
  • Supporting or sustaining life.
  • Controlling conception.
  • Disinfecting medical equipment.
  • Providing information for diagnosis, monitoring, or treatment through examination of specimens from the human body.
• Does not use pharmacological, immunological, or metabolic mechanisms in or on the human body. If such mechanisms are used, they are only assistive to achieve the main purpose.

Legal Basis: Clause 1, Article 2, Decree 98/2021/NĐ-CP (November 8, 2021).

Is there a fee for the procedure to announce eligibility?

Yes. According to Decision 2495/QĐ-BYT, the fee is 1,500,000 VND (from July 1, 2025, to December 31, 2026) and 3,000,000 VND (from January 1, 2027, onwards).

Who is considered the medical device product owner?

The Product Owner is an organization or individual that:

• Supplies the medical device under
  • its own name, or
  • any trademark, design, trade name, or other name or mark owned or controlled by that organization or individual; AND
• Is responsible for the design, manufacture, assembly, processing, labeling, packaging, or refurbishment of the medical device, or for establishing its intended use.

Legal Basis: Clause 5, Article 2, Decree 98/2021/NĐ-CP (November 8, 2021).

What are the principles of medical device management?

• Ensure the quality, safety, and effective use of medical devices.
• Provide complete, accurate, and timely information on technical characteristics, uses, and potential risks to users.
• Ensure traceability of the medical device’s origin.
• Management must be based on risk classification and corresponding national standards/technical regulations.
• Medical devices that are measuring instruments or radiation-emitting devices must be managed under laws on metrology, atomic energy, and this Decree.
• Chemicals/preparations solely for medical equipment disinfection are managed by this Decree. (Others are managed by laws on chemicals).
• Medical devices and raw materials containing narcotics/precursors must be managed under laws on drug prevention and this Decree.
• Regulations on classification, registration numbers, and trading eligibility announcements do not apply to:
  • Software used for medical devices.
  • Medical devices imported as gifts/donations to individuals or non-medical organizations.

Legal Basis: Article 3, Decree 98/2021/NĐ-CP (November 8, 2021).

Conclusion

Announcing eligibility for trading Class B C D medical devices is a crucial basis for ensuring transparency, legality, and professionalism in business operations. Adhering to these regulations contributes to building a safe, effective, and compliant medical device business environment that meets quality management standards in the healthcare sector.

For detailed consultation and support in executing the procedure quickly and in accordance with legal regulations, please contact Long Phan Consulting via hotline: 1900636389 for professional service.