Retention of online application with medical device management in Vietnam

What are regulations on retention of online application with medical device management in Vietnam?

According to Article 69 of Decree 98/2021/ND-CP, regulations on retention of online application are as follows:

1. When submitting an online application, the applicant is required to retain physical documents of that application in accordance with Clause 1 Article 33 of this Decree.

2. In case any physical document included in the application specified in Clause 1 of this Article is lost or damaged, the applicant shall give a written notice to the receiving authority, reprepare that document and notify the receiving authority in writing of their completion of application, and then follow procedures for updating their application after obtaining an approval from the receiving authority.

3. Within 35 days from the receipt of the written notice of the loss of document, if the applicant fails to give a written notice of their completion of application, the receiving authority shall:

a) Remove all information published on the Portal about the medical device manufacturer, trading establishment or consultant, raw materials for manufacture of medical devices, substances for external quality assessment that contain narcotic substances and precursors, medical device inspection service provider, and registration number of the medical device;

b) Revoke the registration number and license to import medical devices.

4. The applicant shall stop their operation and placement of the relevant medical device on the market from the day on which the information is removed as prescribed in Clause 3 of this Article.

In addition, Article 68 of Decree 98/2021/ND-CP provides for procedures for online declaration as follows:

1. The legal representative or his/her authorized person shall declare information, upload electronic documents, make certification using digital signature (if any) and make online application fee payment according to procedures on the Portal on management of medical devices.

2. The online application receiving authority shall carry out administrative procedures relevant to the application in accordance with regulations of this Decree.

3. Results of online administrative procedures shall have the same legal effect as those of normal administrative procedures.

Best Regards!