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​ 

June 24, 2024
Thailand’s Minister of Public Health recently promulgated the Ministerial Notification Re: Category 5 Narcotics Which Are Not Cannabis or Hemp Extract and Whose Consumption is Permitted for Treatment of Disease or for Research Purposes (2024). The notification took effect on April 23, 2024. The substances whose regulatory controls are affected by this new notification are psilocybin mushroom (Psilocybe cubensis (Earle) Singer), opium poppy (Papaver somniferum L. and Papaver bracteatum Lindl.), and other plants in these genera from which opium, opium alkaloids, psilocybin, or psilocin may be derived. As a result of this notification, these substances are now classified as category 5 narcotics that can be applied in medical treatment. Without the implementation of this notification, patients could not access newly developed medicines containing these substances, as Thailand’s Narcotic Code prohibits the possession and use of category 5 narcotics. Nonetheless, this does not mean that psilocybin mushrooms and opium can be used without any conditions. There is still a long process to go through before these substances can be used in medical treatment or clinical studies. Under the new notification, the FDA must first approve any medicinal drug formulation containing any of the above substances, and subsequently, the production must be approved for medical use or research purposes. The importation of medicinal drug formulations containing psilocybin mushrooms or opium is not allowed. This seemingly small regulatory change addresses the previous legal obstacle to the research and development of such medicines. According to the previous regulation, a physician or researcher could apply to the Thai FDA for a license to produce or possess medicines containing the aforementioned narcotics. However, production and consumption are considered different activities, and consuming a narcotic-containing medicine, even if it was produced under a valid license, is prohibited by the Narcotics Code and is punishable by imprisonment,
Read More
June 11, 2024
Advances in biotechnology have enabled the development of a range of new agricultural tools. From DNA sequencing to plant tissue culture and gene editing, these advances are facilitating the development of better crops. Genetically modified organisms (GMOs) are one well-known example of agricultural biotechnology. GMOs are organisms whose genetic material has been artificially altered by inserting a piece of foreign DNA. This DNA may be synthetic in origin or sourced from other organisms. Genome editing (also called gene editing or GEd) involves making precise changes to an organism’s genome without the integration of foreign DNA elements. Several approaches to genome editing have been developed. A well-known one is called CRISPR-Cas9, in which scientists make precise “cuts” in the DNA to create a new genetic variation. Unlike with GMOs, this introduces only minor modifications that are indistinguishable from natural mutations, typically by transplanting genes that code desirable traits from one species into another. GEd technology has been recognized and supported by the Food and Agriculture Organization of the United Nations (FAO). Thirteen FAO-member countries who are also members of the Organization for Economic Cooperation and Development (OECD) announced their support of the use of GEd technology for commercial uses and consumption at a recent WTO meeting. In addition, over 40 countries around the world, such as Argentina, Australia, Brazil, Canada, Chile, China, England, Japan, Kenya, the Philippines, Russia, the UK, and the US, have published policies emphasizing that foods free of transgenes (i.e., foods that do not contain genes transferred from external sources) are not GMOs, concluding that GEd plants are as safe as normal plants. In February 2024, the European Parliament approved new genomic techniques (NGTs), or GEd. As a result, plants that are produced using GEd technology are not classified by the EU as GMOs, and the EU
Read More
February 14, 2024
Thailand is preparing to implement new rules on drug importation for clinical studies. The Medicines Regulation Department of Thailand’s Food and Drug Administration (Thai FDA) first issued the Notification Re. Detailed Requirements for Drug Importation into Thailand for Clinical Studies almost a year ago, and the notification is expected to come into effect on March 1, 2024. Key Provisions The notification aims at enhancing the efficiency of conducting clinical studies while ensuring the protection of human subjects participating in such studies within Thailand. Some of its key provisions include: Definition of Clinical Study. The notification defines a “clinical study” as a study of a medicine involving human subjects, conducted to provide supporting evidence for the registration of a medicinal product in Thailand or other countries, including for additional indications or variations of a registration dossier. Compliance with ICH GCP. Clinical studies conducted in Thailand must adhere to the current edition of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines. Clinical Trial Application. Sponsors are required to submit a clinical trial application along with supporting documents to the Thai FDA for approval before commencing a clinical study. The permit remains valid for five years and is renewable. Supply of Investigational Drugs. Sponsors must obtain investigational drugs from manufacturers compliant with Good Manufacturing Practice (GMP) standards as recognized by the Thai FDA. Postapproval Obligations. The secretary-general of the Thai FDA may impose postapproval conditions or order investigators to conduct or suspend certain activities to ensure human subject protection and regulatory compliance. Regulatory Oversight. The Thai FDA is responsible for inspecting and overseeing the regulatory compliance of clinical studies, including during prestudy, ongoing, and poststudy phases. The Thai FDA may also conduct inspections of clinical studies conducted overseas. The Thai FDA
Read More
December 15, 2023
As part of its membership in Lex Mundi, Tilleke & Gibbins has published an updated edition of its Guide to Doing Business in Thailand for 2023. This guide outlines the key factors for starting and operating a business in the Thai market. Issues covered include: Investment incentives Financial facilities Exchange controls Import and export regulations Structures for doing business Requirements for the Establishment of a Business Operation of the Business Cessation or Termination of the Business Labor legislation, relations, and supply Tax Immigration requirements This publication is part of Lex Mundi’s Country Guides series prepared by member firms in more than 100 jurisdictions worldwide. The guides serve as a useful resource for planning international business strategy and researching new markets. The full Guide to Doing Business in Thailand is available through the button below.
Read More