{"id":27532,"date":"2023-04-12T10:34:44","date_gmt":"2023-04-12T08:34:44","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27532"},"modified":"2023-04-12T10:57:57","modified_gmt":"2023-04-12T08:57:57","slug":"vietnam-free-sale-for-devices-of-certain-classes","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/04\/12\/vietnam-free-sale-for-devices-of-certain-classes\/","title":{"rendered":"VIETNAM: free sale for devices of certain classes"},"content":{"rendered":"

On 3 March 2023, Decree 07\/2023 ‘Amendments To Government’s Decree No. 98\/2021\/Nd-Cp Dated November 08, 2021 Prescribing Medical Device Management, 2019’<\/em><\/strong> was signed by the Ministry of Health (MoH) of Vietnam.<\/h2>\n

The Decree states that Class C and D Medical Devices<\/strong>, not listed in Circular 05\/2022, can be freely imported into the country.<\/strong> It also introduces changes to the regulatory requirements for In Vitro Diagnostic (IVD) Medical Devices. <\/strong><\/p>\n

Decree 07\/2023 is effective immediately and amends the previous Decree 98\/2022, which came into force on 1 January 2022.<\/p>\n

Specifically, the Vietnamese Ministry of Health issued Decree 07\/2023 to address the high number of applications for registration of Class C and D Devices, providing for the following time frame:<\/p>\n

– extension until 31 December 2024<\/strong> of import licence validity for Class C and D Medical Devices listed in Circular 05\/2022;<\/p>\n

– indefinite<\/strong> extension of Market Authorization (MA) for Class C and D devices;<\/p>\n

– Class C and D Medical Devices not listed Circular 05\/2022 are not affected by the extension.<\/p>\n

The decree also introduces significant requirements that impact the placing of devices on the market in Vietnam, in particular:<\/p>\n

– Medical Devices without the import licence requirement may be imported until 31 December 2024<\/strong> provided the importer declares the classification of the Medical Device on the Department of Medical Equipment and Construction (DMEC<\/strong>) online portal;<\/p>\n

– as of 1 January 2024<\/strong>, the Common Submission Dossier Template (CSDT<\/strong>) replaces the Technical Dossier, IFUs, Labelling, ERC and Brochure and must be written in Vietnamese;<\/p>\n

– dossiers must be approved within three amendment cycles requested by the MoH (one cycle = 90 days);<\/p>\n

– from 1 July 2023<\/strong>, manufacturers and those who market certain medical devices must publish the price of certain medical devices on DMEC;<\/p>\n

– Class A and B devices are supervised by the provincial offices of the MoH, so that the MoH can focus on applications for Class C and D devices;<\/p>\n

– import licences issued to IVD products between 1 January 2018 and 31 December 2018 can continue to be used until 31 December 2024<\/strong>.<\/p>\n

The measure, by which the Vietnamese government decided to extend the validity of import licences until 31 December 2024, aims to address the shortage of Class C and D devices<\/strong> and in vitro diagnostic medical devices<\/strong> in certain regions of the state, thus preserving the import of those devices that are essential to safeguard patients’ lives.<\/p>\n

To stay up-to-date with updates on the regulation of medical devices and IVDs for Vietnamese market access, subscribe to our Newsletter<\/strong>.<\/p>\n

>> Through our strategic regulatory consulting<\/strong><\/a> services<\/a> and support for ministerial registration<\/a> in Vietnam<\/strong>, Thema can help you comply with Vietnamese regulatory requirements.<\/h3>\n

Contact us<\/strong><\/a> for information.<\/p>\n

Sources:<\/strong><\/p>\n

Ministry of Health Vietnam (Moh)<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

On 3 March 2023, Decree 07\/2023 ‘Amendments To Government’s Decree No. 98\/2021\/Nd-Cp Dated November 08, 2021 Prescribing Medical Device Management, 2019’ […]<\/p>\n","protected":false},"author":114,"featured_media":27510,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-27532","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"\nVIETNAM: free sale for devices of certain classes - Thema Med<\/title>\n<meta name=\"description\" content=\"Decree 07\/2023 'Amendments To Government's Decree No. 98\/2021\/Nd-Cp Dated November 08, 2021 Prescribing Medical Device Management...\" \/>\n<meta name=\"robots\" content=\"index, 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