“Manufacturers with multiple license holders will need to ensure they coordinate the maximum price to avoid issues when completing sales transactions.”

David Vo
General Manager
Asia Actual Vietnam

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Vietnam’s Ministry of Health Holds Conference on New Price Declaration Procedures

Published on: April 11th, 2022

Short Term Surge in Purchasing Expected

On March 29, 2022, the Vietnamese MOH hosted a virtual conference to provide clarity to the new Price Declaration process and announce the establishment of a new online portal for license holders to declare prices. This comes as many provincial health services, including Ninh Binh and Dak Nong, have not been able to purchase medical products since January 1, 2022 while they waited for the new portal to be launched. Therefore, it’s expected that there will be a surge in purchasing the next few months as Vietnamese hospitals and medical institutions make up for the last 3+ months.

The MOH’s press release on the conference can be found here.

Main takeaways from the Price Declaration Conference

  • License holders must complete the Price Declarations.
    • Rep Offices are exempt but will need to work with a license holder or distributor to declare prices.
  • MOH will launch a new portal for license holders to complete Price Declarations shortly after the conference (March 29, 2022). All license holders will need to create a new online account.
  • MOH plans to issue additional Decree 98/2021 guidance concerning classifying, grouping, price declaration, etc. at the beginning of April 2022
  • The price declaration portal will only show the end consumer price and specification of the products.
    • It will not show the import price, margin, expense, training service, etc.
    • All the documents related to the import process, margin, expenses and so forth will need to be kept in case tax administration agencies or state management agencies request them.
      • According to Article 78a, Decree 124/2021,i f the license holder is unable to explain the pricing, they will be fined US$650.
  • The price publication portal will be terminated.
  • All government facilities will need to check the portal and purchase medical devices at a price lower than the Price Declaration.
  • Winning bids will continue to be posted publicly
  • Some products may have more than 2 license holders. In these cases, each license holder will need to complete their own Price Declaration. This could cause issues if they are not coordinating.
  • Purchases made by provincial Health Services that have previously committed to prices higher than the new Price Declaration will need to renegotiate with the supplier to meet the new requirements.

Overview of New Medical Device Requirements in Vietnam

The Vietnamese also implemented new requirements for medical devices on January 1, 2022 in accordance with Decree 98/2021. While it provided immediate registration for Class A and B products, Class C and D applications have been marred with delays due to internal interruptions at the MOH.

Some of the main highlights from the new requirements include:

  1. All Class B devices (not covered by a valid Import License) must have a MA License to be imported from Jan 1, 2022. (Note: Class A devices have required an MA License since Jan 1, 2020.)
  2. Class C and D devices (not covered by a valid Import License) that are listed in Circular 30/2015 (link to list here), must have a MA License to be imported from Jan 1, 2022.
  3. Class C and D devices that are not listed in Circular 30/2015, can be imported with a Classification Certificate until Dec 31, 2022 after which a MA License will be required.
  4. Class B MA License application will have the same requirements as for Class A devices starting Jan 1, 2022.
  5. For Class C and D devices with reference country approval, the technical review is waived. MOH application target proceeding time will be 10 days with reference country approval. (Note: China and Korea have been added to the US, Europe, Japan, Australia and Canada as reference countries.)
  6. MA Licenses will be issued without an expiration date (instead of the previous 5-year validity period).
  7. Registration Holders do not need to be the initial importer; and multiple importers/distributors can be authorized under the same MA license.
  8. Third Party Classification process has been removed and is now the responsibility of the applicant/registration holder.
  9. Asia Actual recommends manufacturers of all product categories with Reference Country approval seek an MA license as soon as possible as they do not expire, are reviewed quickly, and can be registered with relatively little documentation.

For more information on the registration process in Vietnam, please see our page on the topic here.

Application Fees and Target Review Times in Vietnam

DMEC Fees Standard Review Time Review Time w/ Reference Country Approval
Class A VND 1 million US$43 Immediate Immediate
Class B VND 3 million
US$130
Immediate Immediate
Class C VND 5 million
US$216
60 days 10 days
Class D VND 5 million
US$216
60 days 10 days
Advertising VND 100,000
US$5
5 days

Come Grow With Us

Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market.

Contact Asia Actual today with any questions on how Decree 98/2021 may affect your business.

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