Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
EPSI GLOBAL PTE. LTD.
Singapore (HQ), Kuala Lumpur, Malaysia, Jakarta, Indonesia, Bangkok, Thailand, Hanoi, Vietnam, Manila, Philippines, Shanghai, China
We provide end-to-end regulatory solutions covering all classes of medical devices and IVDs in major APAC markets, especially the ASEAN region (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines) and major Northeast Asian markets (China, Korea, Japan). Services include classification, registration, local authorized representation, quality management system (QMS) implementation/auditing (ISO 13485/local GMP), and post-market surveillance. Their local presence minimizes market entry risks and time-to-market.
November 16, 2025
Approximately 5 minutes
Vietnam Medical Device Importing and Customs Clearance: Roles and Common Delays
Vietnam Medical Device Importing and Customs Clearance: Roles and Common Delays
The importing process and customs clearance for medical devices in Vietnam, governed under Decree 98/2021, requires precise coordination and documentation. A key feature of the Vietnamese regulatory landscape is the strict separation of roles between the entity holding the market registration and the entity handling the physical importation.
Key Roles in the Import Process
The import process involves two distinct legal entities: the Market Authorization (MA) License Holder and the Importer.
| Role | Responsibility |
|---|---|
| MA License Holder | Holds the official registration/license for the product in Vietnam. Must issue an authorization letter and provide the product's MA License to the licensed Importer to facilitate customs clearance. |
| Importer | A separate, properly licensed local company responsible for the physical logistics, submission of shipping documents, payment of duties, and clearance of the shipment through customs. |
Required Financial and Shipping Documents
The customs clearance process generally aligns with international standards, requiring the submission of standard shipping documents and payment of applicable taxes:
- Import Tax (Duties): Rates vary based on the product’s Harmonized System (HS) Code. Many medical devices may benefit from 0% import duty.
- Value-Added Tax (VAT): The general VAT rate is 10%; however, for medical devices listed in Circular 30, the rate may be reduced to 5%.
Common Causes of Customs Clearance Delays
Manufacturers should be aware of several common inconsistencies that frequently lead to significant and costly delays at customs:
- HS Code Discrepancies: Inconsistency in the HS Code used across different shipments or by different freight forwarders can raise flags.
- Valuation Inconsistency: Discrepancies between the declared value of the goods and the customs assessment of the shipment's value.
- Shipment Completeness: Customs does not typically allow for partial clearance. A shipment containing a mix of valid and expired items will be held entirely until the issue is resolved.
- Labeling Inconsistencies: Discrepancies between the product label/catalogue number that was originally submitted for registration and the actual physical product label/catalogue number on the imported goods.
Ensuring consistency between the License Holder's documentation and the Importer's shipping documents is paramount for smooth and timely market entry.
Related Articles
Approximately 5 minutes
Vietnam Medical Device Registration: Decree 98, MA License, and Transitioning Market
Vietnam’s medical device regulation, overseen by the **IMDA** under the MoH, is transitioning under **Decree No. 98/2021**. All devices require a **Market Authorization (MA) License**, which does not expire. Foreign manufacturers must appoint a local **Registration Holder**. Class A and B devices are immediately listed through a notification process, while Class C and D devices face significant delays but can utilize **Reference Country approval** (US, EU, Australia, etc.) for an expedited review.
Approximately 5 minutes
Vietnam IVD Device Registration: Decree 98 and the Transition to Medical Device Status
Vietnam’s In Vitro Diagnostic (IVD) regulation is under a major transition, consolidating all IVD products under the medical device framework (Decree 98/2021). IVD components are now classified (A to D) based on risk. All classes require a **Market Authorization (MA) License**, which does not expire. Class A/B receive immediate administrative approval, while Class C/D utilize the **Reference Country approval** pathway to expedite the lengthy technical review process.
Approximately 5 minutes
Vietnam Medical Device Classification: GHTF Risk Levels and Registration Holder Responsibility
Medical device classification in Vietnam follows the **GHTF guidelines** and is based on the intended use, risk, and invasiveness, categorizing devices from lowest to highest risk as **Class A, B, C, and D**. Under the new regulations (Decree 98/2021), the responsibility for classifying the product has shifted from a certified third party to the **Registration Holder** as part of the market authorization application.
Approximately 5 minutes
Vietnam Medical Device Grouping: Simplifying MA Licenses under Circular 39/2016 Guidelines
Vietnam allows for the grouping of multiple medical device variations under a single **Market Authorization (MA) License** application, guided by **Circular 39/2016 (Appendix II)**. The primary grouping categories are **Single Family, System, IVD Test Kit, and IVD Cluster**. All grouped devices must share the same product owner, intended purpose, and typically a common proprietary name, streamlining the registration process and saving costs for manufacturers.
Approximately 5 minutes
Vietnam Local Labeling Requirements: Mandatory Vietnamese and Secondary Labeling After Customs
Medical device labeling in Vietnam is governed by **Decree 43/2017** and **Decree 111/2021**. While imported products can have international labels for customs clearance, all devices must be labeled in **Vietnamese** before reaching the end user. This usually requires a **secondary label** to be affixed after importation, including mandatory details such as the product name, License Holder's name and address, and the circulation/MA license number.
Approximately 5 minutes
Vietnam Medical Device License Maintenance: Mandatory Amendments for Post-Approval Changes
Unlike many other markets, Vietnam often requires a formal **amendment** to the Market Authorization (MA) License **before** a modified medical device can be imported or marketed. Changes, even minor ones, such as updating the License Holder's or manufacturer's name/address (but not both), packaging, or IFU/labeling, necessitate a notification to the Ministry of Health (MoH). Failure to comply can lead to customs clearance delays or loss of market access.
Approximately 5 minutes
Vietnam Medical Device Advertising: Mandatory Public Portal Submission and Content Requirements
Under **Decree 98/2021 (Article 62)**, all medical device advertising materials (print, internet, video), including those for healthcare professionals and the public, must be **uploaded to the MoH public portal** before market placement. After uploading, a unique number is generated, which must be displayed on the advertising material. Failure to comply or meet MoH requirements can lead to removal from the market.