On June 30, 2023, the Ministry of Health of Vietnam issued Circular No. 14/2023/TT-BYT stipulating the process and procedure for building bidding package prices for procurement of goods and services in the field of medical devices at public health facilities (“Circular 14”). Circular 14 took effect on July 1, 2023, and will be valid through the end of 2023. Circular 14 applies to the procurement of medical devices/equipment and their accessories, spare parts, and supplies, as well as related services of repair, maintenance, inspection, and calibration. Under Circular 14, there are three methods of determining the price of bidding packages: Collecting quotations provided by suppliers of goods and services in the field of medical devices. Surveying the winning bid prices of similar goods and services on the national bidding network system (https://muasamcong.gov.vn). Using the results of price appraisal of a competent state agency that conducts price appraisal, or a specialized price appraisal enterprise. Method (i) must be used first; the two remaining methods can be applied only after method (i) has been unsuccessful. If the investor/procuring entity uses two or more methods to determine the price of bidding packages, it can select the highest price that is suitable to its financial capacity and professional requirements. Circular 14 further sets out the specific step-by-step process to build prices for procuring products and services in the field of medical devices/equipment. Transitional Provision For bidding packages that have already approved a contractor selection plan before July 1, 2023, the approved contractor selection plan will be followed. For bidding packages for which a contractor selection plan has been submitted by the investor/procuring entity but the plan has not yet been approved, the competent person can decide on the approval of the submitted plan or can request the investor/procuring entity to rebuild the bidding

Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world. The Life Sciences Global Guide is divided into two sections: Regulation (see more details here) and Commercialization, which covers the following topics: Overview of the life sciences sector Pricing, government funding, and reimbursement: National health care system, price regulation and reimbursement Distribution and sale Cross-border trade and parallel imports Advertising to the public and engagement with patient organizations Advertising to healthcare professionals and organizations: Gifts and incentives and transparency and disclosure Patents: Conditions for patentability, registration, length of protection, infringement, international treaties Trademarks: Requirements, registration Competition law issues: Authorities and legislation, commercial contracts and competition law, licensing approvals and formalities Product liability: Regulators, medicinal product liability law, liable partners, defenses, product liability claims, remedies Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Commercialization in Vietnam” section can be found on the Practical Law website.

Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world. The Life Sciences Global Guide is divided into two sections: Commercialization (see more details here) and Regulation, which covers the following topics: Pharmaceuticals: Laws and regulatory authorities Clinical trials: Legal, regulatory, and procedural requirements Manufacturing and distribution Marketing: Authorization for marketing medicinal products, monitoring compliance and penalties, pharmacovigilance and other commitments, foreign marketing authorizations Data privacy Packaging, labeling, and tracking Biological medicines Medical devices: Legislation and regulatory authorities, definition and classification Healthcare IT Combination products and borderlines Natural health products Recent developments and reform proposals Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Regulation in Vietnam” section can be found on the Practical Law website.

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,