Medical Device Manufacturing: Announcement Procedure

The procedure for announcing medical device manufacturing eligibility is a critical administrative step. It ensures manufacturing facilities comply with quality management, safety, and efficiency standards. Understanding and correctly implementing this process helps businesses operate legally and enhances product quality and market reputation.

Administrative Procedure Requirements and Conditions

Before implementing the procedure for announcing medical device manufacturing eligibility, the production facility must meet the quality management conditions specified in Article 8 of Decree 98/2021/NĐ-CP (dated November 8, 2021). These include:

• Achieving ISO 13485 quality management system standards.
• For facilities manufacturing medical devices containing narcotics and precursors, the following additional requirements must be met:
  • Possess a tracking system to manage the import, export, inventory, and use of raw materials (narcotics and precursors) and the inventory of medical devices containing them.
  • Medical devices and materials containing narcotics and precursors must be stored in a separate, secure area or a dedicated warehouse.

Administrative Procedure Resolution Agency

According to Item II.11 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 medical device manufacturing eligibility.

Procedure for Announcing Medical Device Manufacturing Eligibility

A clear understanding of this procedure helps the production facility execute it quickly and effectively, mitigating legal risks.

Dossier Composition

The dossier composition is regulated in Articles 9 and 10 of Decree 98/2021/NĐ-CP. The dossier includes:

• A written announcement of manufacturing eligibility.
• A certificate of ISO 13485 quality management system standards, issued by a conformity assessment body under legal regulations.
• Documents proving the facility meets the conditions for manufacturing medical devices containing narcotics and precursors.

Note: Requirements for the dossier:

• The dossier is prepared as one (01) set.
• All documents must be printed clearly and arranged sequentially; sections must be separated, and the dossier must include a cover and a table of contents.
• If documents are not in English or Vietnamese, they must be translated into Vietnamese. The translation must be legally notarized.
• Requirements for specific documents:
  • ISO 13485 Certificate: The original, a notarized copy, or a copy certified by the facility.
  • Proof of conditions for narcotics/precursors: An original document certified by the facility.

>>> CLICK TO DOWNLOAD: WRITTEN ANNOUNCEMENT OF MANUFACTURING ELIGIBILITY

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Implementation Sequence

The implementation sequence is regulated in Article 11 of Decree 98/2021/NĐ-CP:

• Step 1: Dossier Submission
  • Before commencing manufacturing, the facility must submit the declaration dossier to the Department of Health where the production site is located (the location is based on the address in the quality management system certificate).
  • If the facility has multiple production sites in different provinces, a separate declaration must be filed in each province.
• 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 publicly post the information and the declaration dossier on the electronic portal for medical device management.
• During operation, the facility is responsible for creating a written notification of any changes, attaching relevant documents, and updating these documents in the publicly posted dossier on the portal within 03 working days from the date of the change.

Fees and Charges

According to 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 for announcing medical device manufacturing eligibility. Service contents include:

• Analyzing and assessing compliance with manufacturing eligibility conditions.
• Advising on dossier composition and procedures.
• Advising on potential financial and tax obligations.
• Providing detailed guidance on the implementation process.
• Reviewing the legal validity of documents and evidence submitted to the competent authority.
• 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 contents to the Client as needed.

With a professional and dedicated team, Long Phan Consulting commits to helping Clients complete the procedure for announcing medical device manufacturing eligibility efficiently and in accordance with legal regulations.

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Frequently Asked Questions (FAQ)

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

What is the result of this administrative procedure?

The result is the public posting of the information and the declaration dossier on the electronic portal for medical device management. Legal Basis: Clause 2, Article 11, Decree 98/2021/NĐ-CP (November 8, 2021).

How is a medical device defined?

A medical device is any apparatus, implant, instrument, material, in-vitro reagent/calibrator, or software that meets these 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 via 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.

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

Is there a fee for this procedure?

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 identifier owned or controlled by that entity.
• 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.
• Ensure traceability of the medical device.
• 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, 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 medical device manufacturing eligibility is not only a mandatory legal procedure but also the basis for ensuring product quality, user safety, and business reputation. 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.