Vietnam issues new regulation for medical device management
On 8 November 2021, the Vietnam government signed Decree 98/2021/ND-CP regulating the management of Medical Devices. The new decree enters into force on 01 January 2022. From this date, Decree 36/2016/NĐ-CP, Decree 169/2018/NĐ-CP, and Decree 03/2020/NĐ-CP will become obsolete. The new decree covers many aspects of medical device management from registrations to advertising, from import licenses to pricing. Some of the key highlights of the new decree are mentioned below:
- Class B medical devices are currently required to register in full. As of 1 January 2022 this changes to be the same as for Class A medical devices, submission for declaration of Applicable Standards. Class B medical device registration applications must be uploaded to the local department of health via online portal https://dmec.moh.gov.vn/. Upon approval, a Notification of Applicable Standard will be issued. This has lifetime validity.
- A fast-track route of registration dossiers for medical devices in classes C and D will be introduced. To benefit from the fast-track medical devices must comply with one of the following criteria:
- Has a Free Sale Certificate (FSC) or Market authorization (MA) issued by FDA-USA, TGA-Australia, Health Canada, MHLW or PMDA-Japan, states of the EU, the United Kingdom, Switzerland, NMPA (National Medical Products Administration)-China, MFDS (Ministry of Food and Drug Safety-Korea) or from a country referenced by the Ministry of Health (MoH) in a list which is yet to be published
- Has been granted an Import License or Circulation Number or Circulation Registration Certificate in Vietnam.
- Dossiers that have already been submitted before 01 January 2022 according to Decree No. 36/2016/ND-CP requesting the issuance of Circulation Registration Numbers, shall be handled as follows:
- For class B medical devices, the Ministry of Health shall guide enterprises that have submitted dossiers for review to carry out the declaration of Applicable Standards as prescribed in this Decree without reimbursing the fees already received for evaluation of Circulation Licenses.
- Class C and D medical devices which comply with fast-track conditions (as listed above) will be evaluated through the fast-track route and issued with a Circulation Number
- Class C and D Registration Certificates will have lifetime validity. This means that the validity of registration licenses for all classes A, B, C and D will be infinite i.e. there will be no requirement to re-register.
Classification of medical devices
- Medical devices classes C and D which do not require an Import License according to Circular 30/2015/TT-BYT can use a classification letter that is published in DMEC to import until 31 December 2022. As a reminder the classification letter is issued by a local licensed organisation until the end of 2021 after which it is issued by the license holder/applicant.
- Currently medical devices must obtain a classification result according to Decree 36/2016/ND-CP and Decree 169/2018/ND-CP. The classification result must be issued by a locally licensed organisation. However as from 01 January 2022 a classification letter is to be issued by the applicant/license holder
Common Submission Dossier Template
- The CSDT (Common Submission Dossier Template) will be implemented from 01 January 2023
- Import Licenses of non-IVD Medical devices which were issued from 01 January 2018 will be extended until 31 December 2022.
- Import License applications which were submitted before 01 January 2022 will be handled according to the relevant regulation document (circular No. 30/2015/TT-BYT). Any Import Licenses that are issued will be valid until 31 December 2022. As of 01 January 2022 the MoH will no longer receive applications for Import Licenses – applicants must submit product registration dossiers.
- Currently, applications for advertising approval are required for medical devices which have Import Licenses and Registration Numbers. The application must be approved by MOH. However, from 01 January 2022, the license holder is no longer required to submit the advertising application but advertising content must be uploaded to the online portal before advertising. There is a six month transition period between 01 January 2022 and 01 July 2022 from which date the disclosure of content and advertising of medical equipment will be mandatory. Further guidelines from MOH will be issued.
Price management of medical devices
- Medical devices must not be sold or purchased without a declared price; they may not be purchased at a price higher than that declared on the Ministry of Health’s website at the time of purchase.
- The owner of the product Registration Number/License Holder shall be responsible for a price declaration of the medical device, except for cases in which the license holder is the local authorized representative of foreign traders in which case the license holder could appoint the local distributor to make the price declaration. In cases where multiple distributors jointly distribute an item, the owner of the Circulation Number of the medical device must appoint one distributor to make the price declaration. Other distributors do not have to make a price declaration but must not sell higher than the price declared by the designated distributor.
Comparison between the existing and new regulation as follows:
Decree 98 (effective from 01 Jan 2022)
Implemented from 01 January 2023
Implemented from 01 January 2022
The Registration of Class B
Same as class A submission, under Health Department evaluation
Same as Class C, D submission, under MOH evaluation
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
Fast-track route requirement
– 1 FSC or MA from reference country.
– Was Granted the import license or circulation number
– 2 FSC from reference country.
Reference countries in fast-track condition
FDA-USA, TGA-Australia, Health Canada, MHLW or PMDA-Japan, states of EU, England, Switzerland and adding: NMPA (National Medical Products Administration) -China, MFDS (Ministry of Food and Drug Safety-Korea
FDA-USA, TGA-Australia, Health Canada, MHLW or PMDA-Japan, states of EU, England, Switzerland
For more information
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