Medical devices have become one of the most widely traded product categories, especially after COVID-19 pandemic worldwide. Such a demand has driven more enterprises and individuals to engage in the medical device manufacturing industry to meet urgent healthcare needs. However, it is considered a conditional business sector, not every facility can freely conduct the manufacturing of medical devices. 

So, what are legal requirements for establishing a medical device manufacturing facility? And what are the fines for violating these regulations? In this article, NPLaw provides detailed legal insights into these main issues.

I. What is manufacturing of medical devices?

In the healthcare sector, medical devices (fully termed medical technical equipment) include devices, machinery, instruments, implantable materials, in-vitro testing reagents and calibrators, and other materials applying scientific and technological advancements for medical diagnosis and treatment.

Accordingly, manufacturing of medical devices refers to the process of producing these items to supply healthcare facilities with essential tools and equipment for diagnosis and treatment.

II. Legal regulations on the manufacturing of medical devices

1. Conditions for establishing a manufacturing facility of medical devices

The manufacturing of medical devices is a conditional business activity, facilities must comply with the requirements stipulated in Article 8 of Decree 98/2021/NĐ-CP.

  • General requirement:
  • Every manufacturing facility must obtain ISO 13485 standard for Quality management system.
  • Additional requirements for facilities manufacturing devices containing narcotic or precursor substances:

    + Obtaining a tracking system for importing, exporting, storing, and using raw materials containing narcotic or precursor substances, as well as tracking medical devices containing these substances.

    + Storing such substances and devices in a separate, secure area or warehouse to ensure safety and regulatory compliance.

2. Dossier for declaring eligibility to manufacture medical devices

Under Article 9 of Decree 98/2021/NĐ-CP, a facility must prepare the following documents to declare eligibility for manufacturing medical devices: 

  • A written declaration of eligibility for manufacturing;
  • An ISO 13485 quality management system certificate, issued by a legally recognized conformity assessment organization;
  • Supporting documents proving compliance with specific conditions for manufacturing devices containing narcotic or precursor substances (if applicable).

3. Procedures for declaring eligibility

Facilities must implement the procedure outlined below:

Step 1: Preparing the dossier (based on Article 10 of Decree No. 98/2021/ND-CP) 

  • All documents must be clearly printed, arranged in order, and separated by sections, and include a cover page and table of contents.
  • Any documents not in Vietnamese or English must be translated into Vietnamese, and the translations must be notarized or legally certified.
  • ISO certificates must be original copies, notarized copies, or copies certified by the facility.
  • Proof of compliance with Law for facilities manufacturing devices containing narcotic or precursor substances must be original copies certified by the facility.

Step 2: Submitting the dossier

  • Under Clause 1, Article 11 of Decree 98/2021/NĐ-CP, facilities must submit their dossiers to the Department of Health in the locality where the manufacturing site is located.
  • If the facility has multiple sites in different provinces, separate declarations must be submitted to each provincial Department of Health.

Step 3: Disclosing of eligibility 

  • Upon receipt of the valid dossier and proof of fee payment, the Department of Health will publicly post the information and dossier on the Medical Device Management Portal.
  • Facilities must update their dossiers within 03 working days of any changes to the information declared.

III. Common questions about manufacturing medical devices

1. Is ISO 13485 certification only sufficient to conduct manufacturing of medical devices?


Based on Article 9 of Decree No. 98/2021/ND-CP, ISO 13485 certification is only one component of the required dossier. Facilities must also submit a declaration of eligibility and documents proving compliance with narcotic or precursor-related regulations.

2. Which ISO certification qualifies a facility for manufacturing of medical devices?


Based on Article 8 of Decree No. 98/2021/ND-CP, ISO 13485 certification meets the legal requirements for manufacturing of medical devices.

3. Must facilities go to government agencies in person to declare eligibility?


Under Clause 1, Article 66 of Decree 98/2021/NĐ-CP, the declaration can be made online, eliminating the need for in-person submission.

IV. Legal consultation for manufacturing of medical devices

If you are planning to establish a manufacturing facility of medical devices or wish to better understand the legal framework surrounding such an industry, you can contact Attorney/Lawyer Nguyễn Ngọc Phú as a Director of NPLaw and a member of the Ho Chi Minh City Bar Association. With years of legal expertise and specialized knowledge, Attorney Phú can provide strategic advice and practical guidance to ensure compliance with all regulatory requirements.

For further assistance, contact NGOC PHU LAW COMPANY LIMITED (NPLaw):