On March 3, 2023, the Government issued Decree No. 07/2023/ND-CP ("Decree 07") amending and supplementing a number of articles of Decree No. 98/2021/ND-CP ("Decree 98") on the management of medical device ("MD") to solve several problems in the market supply. Decree 07 has some notable issues as follows:
1. Supplementation of regulations on revocation of ME registration number
a. Supplementation of a case where registration number is revoked: The components of application for MD registration number that is considered illegitimate by the competent authority.
b. Settlement of MD after the registration number revocation:
- For MD sold to health facilities or users: it is allowed to be used continuously until the liquidation or their expiration date, unless the errors of those MD are unrecoverable and adversely affects the health of users.
- For MD’s registration number that has been revoked but has yet been sold to users or health facilities: the owner of the registration number must cease the circulation and take measures for recall.
2. Expansion of the MD’s price disclosure scope and form
Previously, the price disclosure of MD only took place in the their trading area. However, Decree 07 supplements a disclosure form of Mes’ price for business organizations and individuals, as on the website of the Ministry of Health.
Additionally, under Decree 07, the provision of “Do not trade medical devices before their prices are declared or at prices higher than those available on the Ministry of Health’s Portal on management of medical devices at the time of trading” is not compulsorily applicable for bidding package opened before April 1, 2022.
3. Adjustment on price declaration of MD
Previously, the owner of the registration number was responsible for declaring the price before putting the first MD into the market. However, Decree 07 requires all organizations and individuals producing and trading MD on the list of price declaration subjects, must make the declaration in accordance with the law on prices.
The Minister of Health shall promulgate, update, and adjust the list, and guide on the price declaration of MD.
4. Removal of the import license for used MD
Instead, unregistered MD that is bought by the Official Development Assistance (ODA) and preferential loans and non-refundable aid that are not under official development assistance, will need to obtain a license prior to importation.
The importation of used MD shall be carried out in accordance with the law on foreign trade management.
Decree 07 takes effect from the date of issue.
Comment: