Over recent years, the Vietnamese Government has issued various Decrees regulating the management of medical devices including:
- Decree No. 36/2016/ND-CP dated 15 May 2016;
- Decree No. 169/ND-CP dated 31 December 2018,
- and Decree No. 03/2020/ND-CP dated 01 January 2020.
However, in order to unify regulations on medical device and equipment management, the Ministry of Health has developed a new draft Decree to replace the above three Decrees. The draft Decree includes provisions to reduce and simplify business investment conditions, administrative procedures in the field of advertising, procedures for the declaration and quick issuance of circulation numbers, as well as additional regulations on clinical trials, and the import and export of materials for the production of medical devices.
Some of the key highlights are mentioned below:
- CSDT dossiers will be implemented from 01 Jan 2025 (previously this was announced to be 01 January 2022).
- The registration of class B medical devices will be changed to a Declaration of Applicable Standards which is the same as for class A medical devices. Evaluation of applications is to be undertaken by the local Health Department and no longer the Ministry of Health.
- Registration dossiers submitted before 01 Jan 2022 and in accordance with Decree 36/2016/NĐ-CP will be handled as follows:
- The Ministry of Health will instruct applicants who have submitted registration dossiers for Class B medical devices to apply for the Declaration of Applicable Standards, however, no additional government fees will be due.
- The registration dossier of classes C, D will be issued with a Registration Certificate/Product License if the medical device fulfills one of the criteria below:
- Was granted a Free Sales Certificate issued by the US FDA, Australia’s TGA, Health Canada, MHLW or PMDA (Japan), states of the European Union, the United Kingdom, or Switzerland (hereafter reference countries)
- Was previously granted an Import License or Registration Certificate in Vietnam.
- The Import License will be valid until 31 December 2022.
- The classification letter from now on will be issued by the applicant/license holder – previously this had to be issued by a local licensed organization.
- The validity of the Circular Certificate will be infinite for all licenses of class A, B, C, D medical devices.
Here is a comparison between the draft Decree and existing decree 36/169/03 :
Highlight | Draft of new regulation | Decree 36/169/03 |
CSDT | Implemented from 01 st Jan 2025 | Implemented from 01 st Jan 2022 |
The Registration of Class B | Same as class A submission, under Health Department evaluation | Same as Class C, D submission, under MOH evaluation |
Classification letter | Issue by applicant/license holder | Issue by the local licensed organization |
Validity of circular certificate | Class A, B, C, D: Infinite | Class A: Infinite Class B,C,D: 5 years |
For more information
If you wish to know more about how these regulations will affect your product please contact the Regulatory Affairs Specialist in charge of your dossier or contact us via the button below.
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