You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

March 1, 2019

Vietnam Issues Key Consumer Protection Directive

Subscribe to Updates

Vietnam’s Central Party Steering Committee recently issued a strong directive ordering strict policies emphasizing improved consumer protection. Specifically, Directive No. 30/CT/TW on Strengthening Party Leadership and State Management Responsibility in Consumer Protection (Directive 30) was issued on 22 January 2019.

Directive 30 instructs party and statement management officers at all levels to place increased emphasis on consumer protection to protect the health and safety of citizens, and to keep in proper step with the country’s overall international economic integration. Some highlights of Directive 30 include directives related to the following:

  1. Assigning specific duties to each state agency in regard to consumer protection activities;
  2. Improving the legal regime for consumer protection, including updating the Law on Consumer Protection of 2010;
  3. Consolidating the various state agencies with responsibility for consumer protection to fill any gaps, and increasing training of officials on consumer protection matters;
  4. Increasing public awareness programs on consumer protection, including those in relation to product quality and good business ethics;
  5. Increasing inspections and sanctions for consumer protection law violations;
  6. Simplifying mechanisms for consumers to lodge complaints, and encouraging mediation between businesses and consumers;
  7. Creating favorable conditions for social organizations to help in consumer protection;
  8. Promoting a healthy business climate where product quality is emphasized in competition; and
  9. Increasing Vietnam’s participation in international and regional consumer protection organizations.

Consumer protection law has been making strides over the years in Vietnam, but due to various objective and subjective factors, it still has room for improvement. Directive 30 is a clear signal that the leaders of Vietnam feel that improving consumer protection is definitely the right move to help improve the business climate in Vietnam, and also will help protect the health and safety of citizens.

Related Professionals

Industries

Life Sciences

Practices

Corporate/M&A

Regulatory Affairs

Location

RELATED INSIGHTS​ 

March 24, 2023
Attorneys in Tilleke & Gibbins’ Jakarta office have contributed a new “Life Sciences Regulation in Indonesia” chapter to Practical Law’s updated Life Sciences Global Guide. The chapter covers a range of regulatory issues related to the development, manufacturing, and selling of pharmaceutical products and medical devices, including 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 Developments, reforms, and 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 Indonesia” chapter can be accessed on the Practical Law website
Read More
March 24, 2023
Tilleke & Gibbins’ life sciences specialists in Indonesia have contributed a new “Life Sciences Commercialization in Indonesia” chapter to the Life Sciences Global Guide from Practical Law. This Q&A guide to commercializing life sciences innovations in Indonesia provides important information that companies can use to shape their strategies for life sciences products and activities in the jurisdiction. Specifically, the chapter covers: 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 and engagement with patient organizations 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 Indonesia” section can be found on the Practical Law website.
Read More
March 7, 2023
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,
Read More
March 7, 2023
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
Read More