On 8 November 2021, the Government issued Decree No. 98/2021/ND-CP on management of medical devices (“Decree 98“). Decree 98 took effect from 1 January 2022 and replaced Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP.
- Decree 98 sets out new regulations on the registration numbers of medical devices and a new fast-track approval process for the registration of Class C and D medical devices.
- Decree 98 sets out new regulations on import licenses, product classification, price management measures, advertisement, clinical trials, and post-market management.
1. Product registration/notification
Under Decree 98, Class A and B medical devices are subject to product notification with the local Department of Health. Meanwhile, Class C and D medical devices are subject to product registration with the Ministry of Health.
The registration numbers of Class A, B, C and D medical devices will remain valid indefinitely.
However, the validity of registration numbers in emergency cases involving epidemic prevention and control and natural disaster recovery shall be subject to the Minister of Health’s decision, depending on each specific case.
The Common Submission Dossier Template (CSDT) application will be mandatory from 1 January 2022.
Fast-track approval for Class C and D registrations
In the following cases, product registrations are eligible for fast-track approval:
a. Medical devices that have been issued a Certificate of Free Sale (CFS) or Market Authorization (MA) by any of the following authorities:
- Food and Drug Administration (FDA) – USA
- Therapeutic Goods Administration (TGA) – Australia
- Health Canada, Ministry of Health, Labor and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency (PMDA) – Japan
- EU member countries, the United Kingdom and Switzerland
- National Medical Products Administration (NMPA) – China, Ministry of Food & Drug Safety (MFDS) – Korea
- Other organizations that grant market authorization recognized by Vietnam
b. Medical devices that have been issued import license or registration numbers or CFS under commercial form in Vietnam
2. Import license
The import license only applies to products without a registration number, such as those used for scientific research, testing, inspection, experiments, clinical trials, quality evaluation, training, donation, gift, display, exhibition, product introduction, etc.
3. Product classification
Unlike the previous regulations, Decree 98 allows the applicant to classify products by itself. This will help simplify the classification process and save cost for the applicant.
4. Price management
Decree 98 sets out new regulations on price management measures for medical devices in order to address shortcomings and inadequacies in the previous price management system, as follows:
- Declare the prices of medical devices before circulation in Vietnam and update prices on the Ministry of Health portal.
- List the wholesale and retail prices of medical devices in Vietnamese dong at the place of transaction or the place of sale of medical devices of the establishment trading medical devices; publicly announce such prices on the board, on paper or in other forms.
- Publicize the winning bids for medical devices of public medical facilities.
- Not buy or sell medical devices without a declared price and not buy or sell higher than the price declared on the website of the Ministry of Health at the time of purchase and sale.
Before 1 April 2022, the holders of registration numbers or of import licenses issued before 1 January 2022 have to declare the prices of medical devices as prescribed by this Decree.
5. Information and advertisement
Registration number holders and trading establishments are responsible for publishing risk levels and other information related to the use of medical devices.
Prior to releasing advertisements, the registration number holder or its delegate is responsible for publishing on the portal of the Ministry of Health the advertising content and form.
The requirement to publish advertising content for medical devices will take effect from 1 July 2022.
6. Clinical trials
Decree 98 sets out the regulations on clinical study phases for medical devices, requirements for medical devices undergoing clinical study, requirements for organizations conducting clinical study on medical devices, clinical study dossiers, procedures for approval of clinical study on medical devices, procedures for approval of changes to clinical study on medical devices, procedures for approval of clinical study results for medical devices, responsibilities of organizations or individuals whose medical devices are undergoing clinical study, and the responsibilities of clinical study institutions.
7. Post-market management
Decree 98 requires the registration number holder to organize and manage the tracing of the origin of medical devices placed on the market and fully retain the relevant documents to support the management of medical devices.
Decree 98 also sets out regulations on: (i) handling of medical devices that pose a serious threat to public health or may lead to users’ death; (ii) actions to be taken in case of an adverse event (AE) that has caused harm to the health of users; (iii) handling, repair and recall of defective medical devices; and (iv) handling of medical devices in case the product owner or registration number holder no longer engages in manufacturing, goes bankrupt or is dissolved.
The full Vietnamese text of the Decree can be found here.