Class B medical device registration with the Vietnam MOH refers to the official notification and approval process required for legally marketing low to moderate-risk medical devices in Vietnam. This process is regulated by the Ministry of Health (MOH) under Decree 98/2021/ND-CP, which governs the management of medical devices.

📌 What Does It Mean?

✅ Class B: Risk Level

• In Vietnam, medical devices are categorized into Classes A, B, C, and D based on risk, following ASEAN/GHTF guidelines:

  • Class A – Low risk (e.g., bandages)

  • Class B – Low to moderate risk (e.g., suction pumps, reusable surgical instruments)

  • Class C/D – Moderate to high risk (e.g., infusion pumps, implants)

Class B devices typically:

• Have direct contact with the body but are not invasive beyond a short period.

• Do not pose high potential for harm if malfunctioning.

✅ Registration Purpose

• To ensure the safety, effectiveness, and quality of the device before it enters the Vietnamese market.

• Required to obtain a product listing number (Số lưu hành) from the MOH for:

  • Importation

  • Commercial sale and distribution

  • Customs clearance

✅ Legal Basis

• Governed by:

  • Decree 98/2021/ND-CP (effective January 1, 2022)

  • Circular 05/2022/TT-BYT (labeling and technical documentation)

  • ASEAN Medical Device Directive (AMDD) framework

✅ Key Features of Class B Registration

✅ Why It Matters

Without successful Class B registration:

• The product cannot be legally imported or sold in Vietnam

• Customs will reject shipments

• The manufacturer or distributor may face legal penalties

Contact Us：

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