Class A B Medical Device Standard Declaration Guide

The Class A B medical device standard declaration is a mandatory step to ensure products circulating on the market meet all safety and functional requirements stipulated by law. A clear understanding of the sequence, dossier, and conditions for this procedure helps establishments be more proactive in their business activities.

Requirements and Conditions for the Administrative Procedure

Before performing the Class A B medical device standard declaration, the declaring establishment must meet the conditions for an organization eligible to be named on the declaration, as specified in Article 25, Decree 98/2021/ND-CP (dated November 8, 2021).

The declaring establishment must satisfy the following conditions:

• Organizations eligible to be named on the medical device standard declaration include:
  • Vietnamese enterprises, cooperatives, or business households that own the medical device.
  • Vietnamese enterprises, cooperatives, or business households authorized by the medical device owner.
  • Permanent representative offices in Vietnam of a foreign trader, where that trader is the medical device owner or is authorized by the device owner.
• The organization named on the declaration must have a warranty facility in Vietnam or possess a contract with an organization qualified to provide warranty services for the medical device. This is exempted for single-use devices (as specified by the owner) or if documentation proves no warranty is provided.
• If the declaring organization is a permanent representative office of a foreign trader, the medical device owner must have a warranty facility in Vietnam or a contract with a qualified warranty facility, subject to the same exceptions.
• The warranty facility must be certified by the medical device owner as competent to warranty the product.

Administrative Procedure Resolution Agency

According to Item II.13 of the administrative procedure list issued with Decision 2495/QĐ-BYT (dated August 4, 2025), the specialized medical agency under the provincial-level People’s Committee (the Department of Health) has the authority to resolve the Class A B medical device standard declaration procedure.

Procedure for Class A, B Medical Device Standard Declaration

Understanding the Class A B medical device standard declaration procedure helps the declaring establishment execute the process quickly and efficiently, mitigating legal risks.

Dossier Components

The dossier components for the Class A B medical device standard declaration are specified in Article 26, Decree 98/2021/ND-CP.

The dossier includes:

• The written declaration of applicable standards for the Class A, B medical device.
• A valid ISO 13485 quality management system certificate at the time of submission.
• A valid Letter of Authorization from the device owner to the declaring organization at the time of submission, unless the Vietnamese enterprise, cooperative, or business household is the device owner.
• A confirmation of warranty eligibility issued by the device owner, except for single-use devices or if documentation proves no warranty is provided.
• A summary of the medical device’s technical specifications in Vietnamese, accompanied by technical documents describing the function and technical parameters issued by the device owner.
• A Certificate of Conformity as regulated or the product standard announced by the device owner.
• For domestically manufactured devices, results of assessment for chemical, physical, microbiological, and other parameters issued by a qualified conformity assessment body, or a Certificate of Quality Assessment issued by a competent Vietnamese authority for in vitro diagnostic medical devices. The results must conform to the standard declared by the device owner.
• The Instruction for Use (IFU) of the medical device.
• The label sample that will be used when circulating the medical device in Vietnam.
• A valid Certificate of Free Sale (CFS) at the time of submission for imported medical devices.

Furthermore, the declaration dossier must meet the requirements specified in Article 27, Decree 98/2021/ND-CP:

• The declaration dossier shall be prepared as one (01) set.
• Requirements for specific documents:
  • ISO 13485 Certificate: Submit the original, a certified copy, or a copy confirmed by the declaring organization. If the Certificate is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be legally certified.
  • Letter of Authorization and Warranty Confirmation: For domestic devices: Submit the original or a certified copy. For imported devices: Submit the consularized original or a certified copy of the consularized version.
  • Certificate of Conformity or Standard: Submit the original or a copy confirmed by the declaring organization. If the Standard is not in English or Vietnamese, a certified translation is required.
  • Instruction for Use (IFU): Submit a Vietnamese version confirmed by the declaring organization, accompanied by the original English version issued by the device owner (for imported devices). If the IFU is not in English or Vietnamese, a certified translation is required.
  • Label: Submit a label sample confirmed by the declaring organization. The label must meet the requirements of laws on goods labeling.
  • Certificate of Free Sale (CFS): Submit the consularized original or a certified copy of the consularized version. If the CFS is not in English or Vietnamese, a certified translation is required.
  • Evaluation Results (for domestic IVD): Submit the original or a certified copy.

>>> See more at:

• Standard declaration document for Class A and B medical devices
• Warranty eligibility confirmation certificate
• Authorization letter template

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Procedure Sequence

The sequence for the Class A B medical device standard declaration procedure is specified in Article 28, Decree 98/2021/ND-CP.

• Step 1: Dossier Submission: Before circulating the Class A, B medical device, the declaring establishment is responsible for submitting the declaration dossier to the Department of Health where its business is located.
• Step 2: Public Posting on Electronic Portal: Upon receiving the dossier (including confirmation of fee payment as required by the Ministry of Finance), the Department of Health will post the Applicable Standard Declaration Number for the Class A, B medical device publicly on the electronic portal for medical device management. The declaration dossier is also posted, excluding document (6) (the standard itself).

Fees and Charges

According to Item II.13 of the administrative procedure list issued with Decision 2495/QĐ-BYT, the fees for the Class A B medical device standard declaration are:

• From July 1, 2025, to December 31, 2026:
  • Class A medical device: 500,000 VND
  • Class B medical device: 1,500,000 VND
• From January 1, 2027, onwards:
  • Class A medical device: 1,000,000 VND
  • Class B medical device: 3,000,000 VND

Consulting and Authorization Services

Long Phan Consulting Company provides comprehensive services for the Class A B medical device standard declaration procedure. Our services include:

• Analyzing and assessing compliance with declaration conditions.
• Advising on dossier components and procedure.
• Advising on potential financial and tax obligations.
• Providing detailed guidance on the procedure.
• Checking the legal validity of documents before submission.
• Drafting and preparing the complete necessary dossier.
• Acting as the Client’s authorized representative to submit the dossier and monitor processing.
• Receiving and delivering results, explaining the content to the Client.

With a professional team dedicated to support, Long Phan Consulting Company commits to helping Clients complete the Class A B medical device standard declaration correctly and efficiently.

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Frequently Asked Questions

Below, Long Phan Consulting Company provides answers to common questions regarding the Class A B medical device standard declaration.

What happens if the medical device owner changes?

In case of a change in the medical device owner, device type, model, intended use, or indications, or the addition of a production facility or product code, the registration holder is responsible for re-implementing the standard declaration procedure. Legal basis: Clause 3, Article 28, Decree 98/2021/ND-CP (November 8, 2021).

What are the holder’s responsibilities during medical device circulation?

During circulation, the declaration number holder must submit a written notification of changes, along with related documents, and update the declaration dossier on the electronic portal within 05 working days of any of the following:

• Change of address of the device owner or the declaration number holder.
• Change of name of the declaration number holder or the device owner.
• Change in the name or address of the medical device manufacturer.
• Change in packaging specifications.
• Change in the warranty facility.
• Change in the label or IFU that does not alter the intended use or indications.
• Reduction of production facilities, models, or product codes. Legal basis: Clause 4, Article 28, Decree 98/2021/ND-CP (November 8, 2021).

What cases are exempt from the standard declaration?

Exemptions include:

• Devices used only for research, testing, calibration, quality assessment, training, or repair.
• Devices imported for humanitarian aid, exhibition, product introduction, or as gifts/donations to medical facilities, or for specific personal/diagnostic needs.
• Unregistered devices imported to meet urgent needs for epidemic control or disaster relief where no substitutes are available.
• Devices manufactured in Vietnam solely for export or for participation in overseas exhibitions. Legal basis: Article 24, Decree 98/2021/ND-CP (November 8, 2021).

How are medical devices classified?

Medical devices are classified into 4 types based on the potential risk level:

• Class A: Low risk.
• Class B: Low-medium risk.
• Class C: Medium-high risk.
• Class D: High risk. Legal basis: Article 4, Decree 98/2021/ND-CP (November 8, 2021).

What are the management principles for medical devices?

Principles include:

• Ensuring quality, safety, and effective use.
• Providing complete, accurate, and timely information on technical characteristics and risks.
• Ensuring traceability.
• Management based on risk classification and national standards/technical regulations.
• Measuring devices and radiation equipment are also managed under laws on metrology and atomic energy.
• Chemicals/preparations containing narcotics or precursors are managed under drug control laws. Legal basis: Article 3, Decree 98/2021/ND-CP (November 8, 2021).

Conclusion

The Class A B medical device standard declaration plays an important role in ensuring product quality and safety before widespread use. For detailed consultation and support in executing this procedure quickly and in compliance with the law, please contact Long Phan Consulting Company immediately via hotline: 1900636389 for professional service.