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.