Chương XI Nghị định 98/2021/NĐ-CP: Công bố, đăng ký trực tuyến

Chapter XI

ONLINE DECLARATION AND REGISTRATION

Article 66. Online procedures

1. Declaration of eligibility for manufacture of medical devices.

2. Declaration of applied standards for medical devices.

3. Application for registration of medical device.

4. Declaration of eligibility for medical device trading.

5. Declaration of eligibility to provide medical device technical consulting.

6. Application for certificate of registration of medical device inspection services.

7. Application for license to import medical devices.

8. Application for Certificate of Free Sale for domestically manufactured medical device.

9. Declaration of prices of medical devices.

10. Declaration of concentration/content of raw materials for manufacture of medical devices and substances for external quality assessment that contain narcotic substances and precursors.

11. Declaration of contents and form of advertising of medical device.

Article 67. Requirements for online application

An application for declaration, registration, and issuance of license or CFS submitted online (hereinafter referred to as “online application”) shall be considered valid when it meets the following requirements:

1. It contains adequate documents which are prepared according to regulations applicable to a physical application and converted into electronic documents. The name of an electronic document must be relevant to the name of the physical document.

2. Information on declaration, application for registration or license is complete and accurate.

Article 68. Procedures for online declaration

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.

Article 69. Retention of online application

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.