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

January 30, 2019

Decree 169: New Regulations on Medical Devices in Vietnam

Subscribe to Updates

On December 31, 2018, the Vietnamese government promulgated Decree No. 169/2018/ND-CP (Decree 169), amending Decree No. 36/2017/ND-CP (Decree 36) on medical device management. Decree 169 took immediate effect upon its issuance. The new regulations will have a great impact on the circulation of medical devices, especially foreign products, in Vietnam. Some of the major changes are set out below.

Classification of Medical Devices

Medical devices in Vietnam are classified and managed based on their potential risks, as determined by qualified entities. Under the previous regulation (Decree 36), risk classification results from qualified foreign entities could be recognized in Vietnam without conducting a separate local classification. This was beneficial to foreign manufacturers who sell their products in many countries, as it required no further time and expense for the local classification procedure in Vietnam and ensured a single classification result across multiple markets.

However, from January 1, 2019, foreign classification results are no longer accepted in Vietnam. Instead, the results must come from qualified local entities. It is worth noting that some local entities, despite being considered qualified by the Ministry of Health (MOH), still do not have appropriate capacity to conduct medical device classifications and, in practice, have issued classification results that were not accurate.

The classification rules under Decree 169 are generally stricter than under Decree36. For example, the final classification results will use the highest risk classification, regardless of whether the product has many use purposes or is combined with other medical devices with different risk classifications.

If an incorrect local classification result is submitted to the authority for product registration purposes, the authority will refuse to grant a product registration number if the number is not yet issued or revoke a registration number that has been granted, and may recall any circulating products.

Transitional Regulations

Decree 169 sets out the transition mechanisms as below.

  • Foreign classification results submitted to the authorities prior to December 31, 2018, will continue to be used for the registration procedure.
  • Local classification results issued before December 31, 2018, will be published on the MOH’s online system (http://dmec.moh.gov.vn) before April 1, 2019. MA license/import license holders are then required to review the relevant classification results in light of the classification rules under Decree 169 and report any incorrect classification to the MOH prior to July 1, 2019.

Registration of Medical Devices

Class A Medical Devices

A major change for Class A (lowest risk) medical devices is that the certificate of free sale (CFS) – not previously required – must now be included in any registration dossier submitted after December 31, 2018. This change may cause some difficulties for foreign manufacturers in terms of cost and time, and in some cases it may be impossible to obtain the CFS because some products that are considered Class A medical devices in Vietnam are not considered medical devices in other countries.

Previously, the granted registration of a Class A medical device could not be amended. If any change arose, a new registration procedure was required. However, Decree 169 stipulates a more flexible mechanism, in which the following changes can be made to the registration during the circulation of Class A medical devices.

  • Address of product owner or license holder.
  • Name of license holder.
  • Either name or address of product manufacturer.
  • Product packaging for in vitro medical devices.
  • Warranty establishments.
  • Labels and instructions for use, but the indication of the product cannot be changed.

Class B, C and D Medical Devices

A positive development for medical device companies is that Decree 169 allows a newly added form of registration, namely, “quick registration.” This will reduce the statutory time required to obtain a registration number from 60 days to 30 days, but is only applicable to the following situations:

  • The product has been circulated in at least two of the following countries: Japan, Canada, Australia, United States, or EU member country.
  • The product was circulated in Vietnam prior to December 31, 2018, and satisfies both of the following conditions: (i) The product was circulated for at least three years within the period of five years before the submission date, and (ii) there have been no warnings about the quality or safety of the product.

Additionally, from July 1, 2020, it will be required to include the ASEAN Common Submission Dossier Template (CSDT) in the submitted registration dossier for Class B, C and D medical devices. At that time, it will no longer be necessary to submit the technical document, instructions for use, and labels. It is expected that the MOH will issue further guidance on CSDT soon.

Decree 169 helps to simplify the customs clearance procedure by emphasizing that medical devices will be allowed to be imported into Vietnam without a written confirmation from the MOH that defines the imported product as a medical device when conducting customs clearance.

Transitional Regulations

In the transition time, it is worth noting the following regulations:

  • Class A medical devices are only allowed to be imported if they are registered.
  • A marketing authorization (MA) license for Class B, C, and D medical devices will only be required from January 1, 2020, onwards, instead of January 1, 2018, as set forth under Decree 36.
  • It is required to have a valid import license to import Class B, C, and D medical devices which are specifically listed out in Circular 30/2015/TT-BYT on Import of Medical Devices (Circular 30). Import licenses issued in 2018 (expiring on December 31, 2018) or 2019 will be valid until December 31, 2019.
  • Class B, C and D medical devices that are not specifically listed out in Circular 30 can continue to be freely imported into Vietnam without any import license, provided that their certificates of classification results are published on the MOH website http://dmec.moh.gov.vn.
  • For IVD biologicals (e.g., microbiology reagents, histology reagents, etc.), Decree 169 sets out specific regulations under which such IVD biologicals can still be treated as drugs under the Pharma Law.
  • For chemicals, insecticides and germicides for household and medical use, with only one indication of disinfecting medical devices, which have been granted MA licenses which expire after July 1, 2016 and before January 1, 2019, their MA licenses will be used until December 31, 2019.
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

July 13, 2026
Indonesia’s Halal Product Assurance Agency (BPJPH) has issued new regulations establishing clearer procedures for imposing administrative sanctions on businesses that violate halal product assurance requirements. BPJPH Regulation No. 2 of 2026 on the Imposition of Administrative Sanctions for Violations of Halal Product Assurance Implementation, issued on June 5, 2026, strengthens Indonesia’s halal compliance framework, as mandated under Law No. 33 of 2014 on Halal Product Assurance and Government Regulation No. 42 of 2024 on the Implementation of Halal Product Assurance. BPJPH Regulation No. 2/2026 also supports the upcoming mandatory halal compliance deadline of October 17, 2026, which will apply to a broad range of products and services, including imported food and beverages, slaughtering products and services, natural and quasi-drugs, health supplements, cosmetics, chemical and genetically engineered products, clothing and accessories, household goods, prayer equipment, stationery, and class A medical devices. Scope BPJPH is authorized to impose administrative sanctions for violations of halal product assurance requirements committed by businesses, halal inspection agencies (LPH), halal auditors, halal product process companion institutions (lembaga pendamping PPH), and halal product process companions (pendamping PPH). The head of BPJPH has authority to determine, cancel, or amend the imposition of administrative sanctions, including upon receipt of objections. This authority covers revocation of Halal Certificates (including foreign halal certificate registration numbers), withdrawal of goods from circulation, freezing of LPH operations, freezing of halal product process companion institutions, revocation of PPH companion institution registration numbers, revocation of halal auditor registration numbers, and revocation of LPH accreditation status. Administrative Sanctions Businesses may be subject to any of the following administrative sanctions: Written warning; Administrative fine; Revocation of the halal certificate, including revocation of foreign halal certificate registration numbers; and Withdrawal of goods from circulation. The regulation sets out the types of violations that may trigger these sanctions, with each
Read More
July 1, 2026
Obtaining marketing authorization is a fundamental requirement for bringing pharmaceutical products to the Thai market. Companies must navigate the Thai Food and Drug Administration’s registration procedures while also complying with post-approval pharmacovigilance obligations, licensing requirements for manufacturing and importation, data protection rules, and other regulatory requirements. This guide provides an overview of Thailand’s regulatory framework for pharmaceutical marketing authorization, including available registration pathways, review timelines, application fees, postmarketing surveillance obligations, licensing requirements, exemptions, data exclusivity, freedom of information, and parallel import considerations. It is intended as a practical reference for pharmaceutical companies, regulatory affairs professionals, and others involved in bringing medicinal products to the Thai market. Download the guide below for a concise overview of the current requirements and procedures governing pharmaceutical marketing authorization in Thailand.
Read More
June 24, 2026
Patent enablement requirements are provided under Article 102 of Vietnam’s Law on Intellectual Property (IP Law). In particular, a patent specification must “fully and clearly disclose the nature of the invention to such an extent that, based on the specification, a person having ordinary skill in the relevant art can implement the invention.” In pharmaceutical and biotechnology patents, this requirement is more complicated and subject to more rigorous assessment. The Patent Examination Guidelines (Guidelines) of the Intellectual Property Office of Vietnam (IP Office) were amended in March 2026 to introduce Annexes III and IV for the pharmaceutical and biotechnology sectors, in which Annex III provides detailed guidelines on the assessment of specification requirements. These amendments were made under a project for strengthening capacity in industrial property examination between the Japan International Cooperation Agency (JICA) and the IP Office. Annex III provides detailed instructions on how examiners assess enablement in a pharmaceutical or biotechnology application, and offers examples of acceptable and unacceptable descriptions with regard to the enablement aspect. Enablement Requirements in Pharma and Biotech Patents Article 12.7 of Circular 10/2026/TT-BKHCN (Circular 10) adds to the requirements of Article 102 of the IP Law that the description must demonstrate the novelty, inventive step, and industrial applicability of the technical solution. For pharmaceutical composition subject matters, Article 12.9 of Circular 10 sets out that the description must present the results of clinical trials and/or the pharmacological effects of the claimed pharmaceutical composition, and must include at least the following information: Substance/mixture used. Testing method (system) employed. Information on the test results. Correlation between the pharmacological effects obtained from the tests and the application of the pharmaceutical product in the prevention, diagnosis, and treatment of diseases. The Guidelines note that pharmacological study results should be presented in a quantified manner, and pharmacological
Read More
June 19, 2026
For the first time, Thailand’s Food and Drug Administration (FDA) has published a consolidated list identifying all substances that have successfully passed its novel food safety evaluation process. The list is a step forward in regulatory transparency, but it also highlights a feature of the Thai regime that food companies often overlook: each approval is tied exclusively to the company that applied for it. A substance’s appearance on the list does not give other companies the green light to use it. This article examines the structure of Thailand’s novel food approval framework, the implications of applicant exclusivity, and the strategic choices it requires of food companies looking to bring novel ingredients to the Thai market. Thai FDA Food Safety Evaluation Framework Notification No. 376 of the Ministry of Public Health requires novel food substances to undergo a food safety assessment, with an exemption only for novel foods manufactured exclusively for export. The framework also encompasses “foods that do not qualify as novel foods” but which present characteristics warranting a safety evaluation, such as differing quality standards, increased serving sizes, or applications in specific food categories, where such changes affect consumption levels, nutritional value, or consumer safety. The recently published list of foods that passed the safety evaluation by the Thai FDA is structured by substance category and identifies the approved company (domestic manufacturer or importer), country of origin, substance name and trade name, approved purpose of use, and date of the Thai FDA’s approval notification certificate. A notable feature of Thailand’s novel food regime is that the approval result is tied exclusively to the company that submitted the application. Publication of the consolidated list does not constitute a general authorization to use the approved substances. The Thai FDA’s approval certificate specifies the approved conditions of use and the requirements
Read More