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

November 24, 2021

New Regulations on Medical Device Management in Vietnam

Subscribe to Updates

On November 8, 2021, the Vietnamese government issued Decree No. 98/2021/ND-CP on the Management of Medical Devices (“Decree 98”). The new decree will take effect from January 1, 2022, replacing Decree No. 36/2016/ND-CP and its amendments on the same subject (“Decree 36”). Below are the main highlights of Decree 98:

1. Classification of Medical Devices

Under Decree 98, responsibility for the classification of medical devices is given to the organization registering or declaring the medical device. Under Decree 36, this responsibility was reserved for Vietnamese organizations qualified for medical device classification.

2. Clinical Trials of Medical Devices

Decree 98 provides stricter and more detailed requirements on clinical trials. Particularly, medical device trials will include three phases, in which phases 1 and 2 need to be finished before the product registration, while phase 3 will be conducted after the medical devices are approved for circulation, following the specific requirement from the authorities. This requirement aims to continue evaluating the safety and efficacy of medical devices after they are widely used in the community in line with their usage conditions.

3. Medical Device Registration

Similar to the current regulations, Decree 98 requires that medical devices must be registered with the Vietnamese authority (i.e., must obtain registration numbers) before being imported/manufactured for circulation in the Vietnam market. However, Decree 98 further stipulates new requirements as below.

Validity of registration numbers

Under Decree 98, the registration numbers for all classes of medical devices, not only Class A medical devices as in the current regulations, are valid indefinitely, except for registration numbers granted under the emergency registration procedure.

Registration procedure for Class A/B medical devices

Instead of having to register with the central level authority with a complex registration dossier as currently required, Decree 98 allows Class B medical devices to be subject to a simpler registration procedure, namely, “Declaration of applied standard” with the provincial level authority, which is the same procedure as for the lowest risk Class A devices.

Registration procedure for Class C/D medical devices

For the first time in Vietnam, Decree 98 sets out three procedures to apply for registration of Class C/D medical devices: the normal registration procedure, a quick registration procedure, and an emergency registration procedure.

The Ministry of Health’s evaluation timeline for handling registration dossiers for Class C/D medical devices under the normal procedure will be up to 45 days, while the timeline under the quick and emergency procedures will be only 10 days.

Quick registration procedure: Class C/D medical devices that are subject to the quick registration procedure will include:

  • Products granted a Certificate of Free Sale (CFS) or marketing authorization (MA) by at least one of the following organizations/countries: the United States Food and Drug Administration; the Therapeutic Goods Administration of Australia; Health Canada; the Ministry of Health, Labor and Welfare or Pharmaceuticals and Medical Devices Agency of Japan; an EU-member country, the U.K., or Switzerland; the National Medical Products Administration of China; the Ministry of Food & Drug Safety of South Korea; or any organization included in the list of MA-issuing organizations recognized by the Vietnam authority (“reference countries”).
  • Products granted import licenses or registration/MA numbers for commercial purposes in Vietnam

Emergency registration procedure: This procedure is applicable to Class C/D medical devices used for epidemic prevention and control and overcoming consequences of natural disasters and catastrophes that are included in the list stipulated by the Minister of Health and fall into one of the following:

  • Products approved for circulation or emergency use by one of the reference countries;
  • Products included in the WHO’s list of products permitted for emergency use;
  • Products included in the list of popular products declared by the EU Health Security Committee;
  • Products granted import licenses or registration/MA numbers for commercial purposes in Vietnam; or
  • Products produced in the form of technology transfer or processing of the above products.

4. Price Management

In an effort to control the price of medical devices, Decree 98 includes a new requirement in which registration number holders must declare the prices of their medical devices on the Portal of Medical Device Management before putting the medical devices on the Vietnam market; the actual prices must not be higher than the declared prices. The authorities may question the registration number holder about grounds for the declared prices at any convenient time.

5. Importation of Medical Devices

Decree 98 sets out situations where medical devices without registration numbers must have import licenses. These include, among others, medical devices for scientific research, tests, trials, quality assessment, or training; medical devices for aid, humanitarian aid, gifts, fairs, exhibitions, displays, or product introduction; and medical devices meeting urgent needs for national defense, security, epidemic prevention and control, and overcoming consequences of natural disasters and catastrophes.

6. Medical Device Advertisement

Decree 98 completely removes the procedure for approval of medical device advertising contents. Instead, the holders of medical device registration numbers or their authorized entities will be responsible for publicly declaring the intended content and form of the advertising on the Portal of Medical Device Management before conducting the advertising.

7. Transitional Regulations

Decree 98 sets out the following transitional mechanisms:

  • Medical devices produced/imported into Vietnam before January 1, 2022, may be continuously circulated until they are liquidated as stipulated or until their expiry date.
  • For import licenses/registration numbers granted before January 1, 2022:
    • Registration numbers granted under Decree 36 and its amendments will be valid indefinitely.
    • MAs granted to domestic medical devices will be valid until their expiry date.
    • Import licenses for medical devices that were granted from January 1, 2018, will be valid until December 31, 2022. Import licenses for medical devices that are IVD biologicals will have no limit on quantity.
    • For Class C/D medical devices that are not subject to import licenses and whose classification results were published on the Portal of Medical Device Management, they can be continuously imported until December 31, 2022, with no limit on quantity and without an approval letter from the Ministry of Health.
    • MAs for medical devices that are IVD biologicals that were granted from January 1, 2014, will be valid until December 31, 2022, or their expiry date, whichever is later.
  • For registration dossiers prepared and submitted in line with Decree 36 but for which registration numbers have not yet been granted as of January 1, 2022:
    • For Class B medical devices, the registrant should conduct the (simpler) procedure for declaration of applied standard with the Department of Health under Decree 98; the governmental fee will be waived.
    • For Class C/D medical devices, if the submitted dossiers comply with Decree 98, they will be reviewed and granted registration numbers in line with Decree 98.
    • Classification certificates issued by local organizations qualified for medical device classification before January 1, 2022, can continue to be used in registration dossiers.
  • Registration dossiers for obtaining import licenses submitted before January 1, 2022, will continue to be reviewed and handled in line with current/old regulations. These import licenses will be valid until December 31, 2022.
  • From January 1, 2023, it will be required to apply the Common Submission Dossier Template (CSDT). Registration dossiers submitted before December 31, 2022, may submit documents including (i) technical summary, (ii) Instructions for use and (iii) label intended for Vietnam market instead.
  • The declaration of advertising content for medical devices will be applied from July 1, 2022.
  • Holders of registration numbers or import licenses granted before January 1, 2022, must take responsibility for price declaration under Decree 98 before April 1, 2022, for medical devices that are circulating in the Vietnam market and before putting medical devices on the Vietnam market for the first time.
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

November 23, 2022
The delisting of cannabis as a controlled narcotic in Thailand on June 9, 2022, was a breakthrough moment for the industry.  Not only are farmers and others in the industry elated that such a step was taken, it has triggered the establishment of an abundance of cannabis dispensaries in Bangkok and other popular domestic and international tourist destinations in Thailand, including Chiang Mai, Pattaya, Phuket, and many islands. Vulnerable populations, such as children, accessing cannabis has also become a hot-button issue. Thailand’s Ministry of Public Health (MOPH) was initially criticized by some for its policy of allowing cannabis to be sold with few restrictions. On June 17, 2022, the MOPH followed up with the Announcement Re: Controlled Herbs (Cannabis) under the Thai Traditional Medical Knowledge Act, which seemed to implement a viable mechanism to regulate cannabis dispensaries. This announcement contained prohibitions on selling cannabis to vulnerable populations (minors, expectant women, and breastfeeding mothers) and on smoking cannabis in public. Furthermore, the draft Cannabis and Hemp Act includes provisions related to sales and distribution channels and advertisements for particular dispensaries. However, the draft act has been delayed due to disagreements among some political parties during the reading of the legislation, and is unlikely to be implemented in 2022 as had been widely expected.  The tug-of-war among the political parties has caused concerns about whether the country’s recent liberalized cannabis policy will be revisited and cannabis relisted as a narcotic. With this uncertainty over when the draft Cannabis and Hemp Act will be implemented, the MOPH has focused on identifying gaps in current regulation that might allow the misuse of cannabis. The minister of the MOPH has announced that the MOPH announcement of June 17, 2022, will be repealed and replaced by the November 11, 2022, Announcement Re: Controlled Herbs (Cannabis).
Read More
November 14, 2022
Following the delisting of cannabis grown in Thailand as a narcotic substance on June 9, 2022, many have explored the applications of cannabis in various fields, including medicine, healthcare, food products, cosmetics, and animal feed. For example, a poultry farm in northern Thailand conducted an experiment jointly with Chiang Mai University, mixing crushed cannabis into poultry feed and water. The experiment showed several benefits of this cannabis feed. Birds that were fed cannabis had lower mortality rates and achieved superior body mass, with increased levels of protein, fat, and moisture in the meat, leading to this method of organic bird farming yielding higher profits. Despite the results of this experiment, the mechanisms and action of cannabis in animal feed are still not yet fully understood, and there are concerns about the possible effects on human health of consuming cannabis-fed poultry. Until recently, cannabis regulations focused solely on the safety of use by humans, and there were no regulations on the use of cannabis in animals. However, on October 11, 2022, the Department of Livestock Development (DLD) published Notification Re: Guidelines on the Use of Hemp and Marijuana as Especially Controlled Animal Feed or Their Use as Ingredients in Especially Controlled Animal Feed in the Government Gazette. In general, the DLD notification requires that animal feed containing cannabis be shown to benefit the animals without causing concern for their safety. According to the Animal Feed Quality Control Act B.E. 2558 (2015), especially controlled animal feed must be registered before it can be manufactured domestically or imported into Thailand. The DLD notification lays down the following evaluation criteria for registration of animal feed containing cannabis: It is prohibited to use cannabis (both hemp and marijuana) apexes (i.e., leaf tips), inflorescence, or seeds—including extracts from apexes, inflorescence, or seeds—as especially controlled animal
Read More
October 14, 2022
Interest in organic farming, soil health, and regenerative agriculture has increased rapidly in recent years, and the demand for biological and organic fertilizers has accordingly undergone dramatic growth. Biological fertilizers contain specific levels of microorganisms (such as nitrogen-fixing bacteria); organic fertilizers similarly contain microorganisms and typically come from animals and plants, such as livestock manure and crop residues. Although responsible fertilizer use is still necessary to prevent unintended effects, these “living fertilizers” can boost yields and promote plant productivity without many of the adverse environmental effects and safety concerns of chemical fertilizers. This makes them highly sought after for organic farming, and prized by agricultural operators looking to promote soil health as a bedrock of sustainable agricultural practices. As the global trade for organic and biological fertilizers has scaled up, producers and agribusiness companies have expanded organic and biological fertilizer offerings to new markets. Not only do different countries have their own regulations for fertilizers in general, but they also often have specific requirements and rules for biological and organic fertilizers. This guide provides fertilizer producers and traders with an overview of the legal landscape for these fertilizers in three major Southeast Asian markets so that businesses can make their fertilizers available and foster sustainable agricultural practices in the region. The full Biological and Organic Fertilizers in Indonesia, Thailand, and Vietnam guide can be downloaded through the button below.
Read More
August 25, 2022
On July 27, 2022, Myanmar’s Ministry of Commerce (MOC) issued Newsletter No. 8/2022 to effectively ban foreign companies and foreign joint ventures from exporting value-added beans, corn, and sesame. This newsletter repealed Newsletter No. 2/2020, which had prescribed the criteria for beans, corn, and sesame to be considered “value-added” crops. These criteria had to be fulfilled in order for these commodities to be exported in accordance with Notification No. 24/2019, which had permitted foreign companies and foreign joint ventures to purchase seven categories of commodities from local manufacturers for export, subject to certain terms and conditions. These include: Meat and fish; Value-added crops; Pulp and paper; Seeds; Refined metals; Semi-finished or finished valued-added fruit products; and Timber-based furniture. With the repeal of the conditions in Newsletter No. 2/2020, foreign exporters are left with no reference criteria for how to achieve “value-added” status for beans, corn, and sesame, and thus will not be able to submit a complete application for the necessary export license. However, exportation of the other items in the list above remains unaffected and open to foreign exporters who meet the applicable requirements. The MOC explained their decision to revoke the permitted criteria by noting that some foreign companies were not actually producing beans, corn, and sesame that fulfilled the criteria for value-added status as laid out in Newsletter No. 2/2020, but were falsely exporting their goods as “value-added crops.” The revocation of the export criteria for beans, corn, and sesame took immediate effect. For more details on these export restrictions, or on any aspect of importation and exportation regulations in Myanmar, please contact Tilleke & Gibbins at [email protected].
Read More