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​ 

October 15, 2025
The Indonesian Food and Drug Administration (BPOM) has introduced more stringent oversight of health supplements containing probiotics with new guidelines that require clinical trials for certain products and expanded documentation standards. BPOM Regulation No. 17 of 2025 replaces the previous 2021 regulation and establishes a comprehensive framework for evaluating probiotic strains used in health supplements. Assessment Requirements The new regulation expands the scope of assessment to include not only categorization and documentation but also technical procedures, strain classification, and clinical trial requirements. Unlike the previous regulation, which provided general guidance, the updated framework creates a comprehensive system for evaluating both registered probiotic strains and new or combined strains. Manufacturers must now submit supporting documentation covering strain identification and functional characterization, safety, efficacy, and product quality. The previous regulation required documentation only on safety, efficacy, and quality. Clinical Trials One of the most significant changes is the requirement for clinical trials conducted in Indonesia for applications that include benefit claims other than maintaining digestive health, or where there are modifications to benefit claims. The regulation specifies that phase 1 trials must demonstrate safety, while phase 2 trials must validate efficacy using statistically valid methods such as double-blind, randomized, placebo-controlled studies). In addition, phase 3 and phase 4 trials may be required, and postmarket surveillance data must be submitted. Technical Assessment Framework Annex 4, a newly introduced section, establishes technical procedures for assessing health supplements containing probiotics in Indonesia. This comprehensive framework outlines criteria for evaluating new probiotic strains, including strain identification, functional characterization, safety, efficacy, and product quality. The annex introduces a clear classification of claims for health supplement products containing probiotics: General claims(e.g., maintaining digestive health). Functional claims(e.g., normal biological function or activity in the body). Risk reduction claims(e.g., lowering disease risk). The regulation restricts use of the term
Read More
October 3, 2025
On September 26, 2025, the Contract Committee under Thailand’s Consumer Protection Board issued a regulation that aims to standardize contracts and enhance consumer protection within the beauty and wellness industry. The Notification on Prescribing the Beauty Service Business as a Contract-Controlled Business B.E. 2568 (2025), which takes effect on January 24, 2026, requires business operators to use a prescribed standard contract in Thai and adhere to strict mandatory provisions and prohibitions. These regulations apply to operators across all in-person and online service channels, including via digital platforms. “Beauty services business” is defined as the provision of services under an agreement allowing consumers to receive a series of treatments, either over a set number of sessions or within a set period. This includes massage, spa, other methods for cleanliness, beauty, or care of facial or body skin, and weight control and body shaping—including services offered electronically. The law excludes surgery, liposuction, and medical treatments performed by licensed practitioners. The notification establishes the following key requirements: Mandatory contract and formatting. All contracts with consumers must use the standard contract form, in Thai, with clear, readable text (minimum font size of 2 millimeters, no more than 11 characters per inch), and include all essential terms from the annexed form. Contract execution. Contracts must be made in duplicate, with one copy given to the consumer at signing. For agreements concluded through electronic channels, the process must comply with the Electronic Transactions Act and use the same required terms. Digital platforms. Business operators who provide services facilitated through a digital platform as an intermediary are ultimately responsible for ensuring the consumer receives a compliant contract. Prohibited clauses. The law prohibits clauses that limit or exclude liability for damages to life, body, health, mind, or property resulting from breach of contract or a wrongful act;
Read More
September 16, 2025
Since Thailand formally removed Mitragyna speciosa (kratom) from the list of narcotic drugs, the country has progressed from outright prohibition to a structured, license-based regime. While the Ministry of Public Health oversees cannabis plant regulation, the Ministry of Justice (MOJ) is the regulatory authority overseeing kratom plants. For the avoidance of doubt, separate Ministry of Public Health notifications prohibit the use of kratom as a food ingredient unless a food safety evaluation has been conducted; however, this restriction does not affect trade in unprocessed leaves per se. For businesses in Thailand dealing exclusively in kratom leaves, the most consequential development is the Ministerial Regulation on the Application for Permits and Notifications for the Importation and Exportation of Kratom Leaves B.E. 2568 (2025), a bylaw of the Kratom Plant Act 2022. The ministerial regulation establishes the following notable definitions: “Kratom leaves”: Fresh or dried leaves in their natural, unprocessed state (no extracts, concentrates, or infused products). “Import/Export”: Any act of bringing kratom leaves into or out of Thailand, whether for commercial sale, industrial processing abroad, or research. Import/Export Licensing Under the Kratom Plant Act, a license is mandatory for importing or exporting kratom leaves. Individuals, juristic persons, community enterprises, and state agencies in Thailand are eligible to obtain a license to import (or a license to export) kratom leaves. Licenses are available to qualified individuals and juristic persons. Individuals must satisfy the following qualifications to be eligible for a license: Thai nationality, ≥ 20 years old, resident in Thailand. Not incompetent, quasi-incompetent, or under legal guardianship. No license suspension currently in force under the Kratom Act or Narcotics Code. No license revocation in the previous two years. No conviction under the Kratom Act or Narcotics Code within the previous two years (unless fully released from punishment). Juristic persons must satisfy
Read More
September 4, 2025
With advancements in health technology, telemedicine has taken on a wider online presence in Thailand. Under the Medical Facility Act, licensed clinics and hospitals may now diagnose, prescribe, and issue electronic prescriptions during a video call, provided they maintain patient confidentiality and proper recordkeeping. As a complementary concept, a telepharmacy allows a pharmacist to verify prescriptions, counsel patients, and dispense medication from a remote site. Hospitals, clinic chains, and some retail pharmacy groups have adopted “drive-thru” or “locker” pick-up points where drugs are bagged only after a real-time video consultation with a registered pharmacist. The clear benefits of telehealth include shorter waiting times and broader access to specialists, which is in the public interest. Drug Distribution and Advertising in Thailand The online pharmacy ecosystem creates a legal bridge in that once a teleconsulting doctor issues an e-prescription, a licensed pharmacy can lawfully dispense and deliver the medicine prescribed to the patient’s door. Nonetheless, the critical compliance component remains the advertising of medicinal drugs. It is still not allowed to advertise prescription/pharmacy-dispensed drugs to the public in Thailand. Although Thailand’s Drug Act of 1967 was written more than half a century ago, it still governs the trading of every medicinal drug that makes its way to consumers in Thailand—whether bought at a pharmacy or delivered with a few taps on a smartphone. First and foremost, the pharmacy must hold a license to sell medicinal drugs as a retailer. It is also mandatory that arrangements be made for a pharmacist to be on duty during opening hours. Drugs are classified into three main categories: prescription drugs, pharmacy-dispensed drugs, and over-the-counter (OTC) drugs. The listing of OTC drugs with their prices via an online platform is allowed, as only OTC drugs may be advertised directly to the public. However, naming or showing
Read More