On March 3, 2023, the government of Vietnam issued Decree No. 07/2023/ND-CP (Decree 07) amending Decree 98/2021/ND-CP on medical device management (Decree 98) to resolve many urgent problems in the healthcare sector in Vietnam. Decree 07 took effect on the same day and amends and supplements several articles in its predecessor, Decree 98, which originally took effect on January 1, 2022. Some outstanding points of Decree 07 are summarized below. 1. Registration of Medical Devices The compulsory implementation of the ASEAN Common Submission Dossier Template (CSDT) in registration applications for medical devices will be delayed until January 1, 2024, instead of the deadline of January 1, 2023 under Decree 98. In addition, if after three rounds of amendment/supplementation as requested by the authority, the registration dossiers still have not been approved, the applicants must submit new registration dossiers. 2. Withdrawal of Registration Number Decree 98 adds one case for withdrawing the registration number of a medical device, which is when the documents in the registration dossier are concluded by the authority to be noncompliant with the provisions of law. 3. Listing Price of Medical Devices It is required for establishments manufacturing or trading medical devices to list their prices in locations stipulated under Article 17 of Decree No. 177/2013/ND-CP implementing the Law on Prices (such as at transaction or selling locations of the trading establishments) or on the online portal of the Department of Medical Equipment and Construction’s (DMEC). 4. Price Declaration It is no longer required to declare prices of all medical devices circulating on the Vietnam market. Instead, the Ministry of Health will issue and adjust the list of medical devices subject to price declaration, depending on management requirements and the actual situation, especially when there are abnormal fluctuations in prices affecting the supply of medical devices,

According to the Ministry of Health of Vietnam, many healthcare facilities in the country are facing a shortage of drugs, medical devices, and materials/chemicals. To address the urgent needs of medical examination and treatment in public healthcare facilities, on March 4, 2023, the government of Vietnam promulgated Resolution No. 30/NQ-CP on continuing to implement solutions to ensure the availability of drugs, medical equipment, and healthcare supplies (“Resolution 30”). Resolution 30 amends item 4 of Resolution No. 144/NQ-CP dated November 5, 2022, allowing medical examination and treatment expenses to continue to be covered by health insurance for technical services carried out with medical devices supplied by contractors after winning tenders to supply materials and chemicals. The new mechanism brings more benefit to patients by removing the previous ending date of November 5, 2023, and will be applicable until there is further guidance from the government. Resolution 30 also allows the use of medical devices that were donated or gifted by domestic and foreign entities (including those that were provided under now-expired joint ventures or cooperation contracts) regardless of whether those entities have fulfilled the procedures for ownership establishment. Technical services that are performed by such devices will be covered by health insurance. This provision will help address the shortage of medical devices used in public hospitals. The determination of bid price is also a highlight of Resolution 30, which pilots a simpler price determination procedure for the purchase of drugs and medical devices. Instead of requiring purchasers to obtain quotations from three suppliers, Resolution 30 allows them to compare prices based on the quotations actually received, even from only one or two suppliers. Alternatively, price determination can be based on the winning bid price for a similar medical device procurement package that was awarded within the last 120 days. This

Vietnam’s Ministry of Finance is drafting a circular on determining the origin of imported and exported goods. This circular, a draft version of which has been released for public comment (“Draft Circular”), consolidates prevailing regulations and guidelines on determining the origin of imported and exported goods that are stipulated in the following legal documents, which the Draft Circular would replace when it comes into effect: Circular No. 38/2018/TT-BTC dated April 20, 2018, of the Ministry of Finance regulating the determination of origin of imported and exported goods, as amended by Circular No. 62/2019/TT-BTC dated September 5, 2019, of the Ministry of Finance; Circular No. 47/2020/TT-BTC dated May 27, 2020, regulating the time to submit documents proving the origin of goods and form of the documents proving the origin of imported goods applied during the Covid-19 pandemic; and Circular No. 07/2021/TT-BTC dated January 25, 2021, regulating the time to submit documents proving the origin of imported goods under the EU-Vietnam Free Trade Agreement (EVFTA). Generally speaking, the Draft Circular does not increase the administrative procedures for importers and exporters, but rather seeks to codify the recent practices implemented by the customs authorities. The Draft Circular focuses on providing comprehensive guidance for importing/exporting companies when carrying out administrative procedures to certify the origins of imported and exported goods to be in line with current trade practices and international commitments under new-generation free trade agreements. In particular, the Draft Circular supplements guidelines on declaring origins and submitting Certificates of Origin (C/Os) of imported goods under the EVFTA and the Regional Comprehensive Economic Partnership Agreement (RCEP). The Draft Circular also provides some new guidelines to facilitate exports (and imports) and overcome some obstacles and issues when implementing the prevailing regulations. For example, the submission of C/Os online, which was only applicable during the

On July 13, 2022, the Vietnamese government issued Decree No. 46/2022/ND-CP amending and supplementing some articles of Decree No. 13/2020/ND-CP providing detailed guidance on the Law on Animal Husbandry (“Decree 46”). The new decree took effect on the issuance date. Among the changes introduced by Decree 46 are a number related to animal feed. Recognition of Testing Methods of Exporting Countries Decree 46 clarifies the steps to recognize animal feed testing methods of laboratories in exporting countries. Under the amended regulations, the Department of Livestock Production (DLP) will organize an assessment team to appraise each dossier for recognition of animal feed testing methods within 30 days of receipt of a complete dossier. If the dossier lacks required information or authenticity, the DLP will organize a practical assessment team at the exporting country’s testing laboratory. If the dossier passes the assessment, within five working days from the completion of the assessment, the DLP will issue a decision on recognition of the testing method. The validity of this decision has been lengthened from three years to five years. State Inspection of Animal Feed Quality Process of State Inspection Decree 46 specifies the process to conduct state inspection of the quality of imported animal feed by unifying the regulations stipulated in the related legal documents listed in Decree 13. The process includes the submission of a state inspection dossier, timelines to receive feedback from the inspection authority, and further steps that can be taken upon receiving acceptance or refusal decisions from the authority. For traditional animal feed and complete compound animal feed, imported shipments are customs-cleared as soon as the importer completes the customs procedures. Within 15 days from the customs clearance date, the importer must submit the conformity assessment results. The importer has complete responsibility for the conformity assessment results, and