What is the application form for issuance of a new registration number of class-C or class-D medical devices which are measuring devices in Vietnam?
- What is the application form for issuance of a new registration number of class-C or class-D medical devices which are measuring devices in Vietnam?
- What is the application for issuance of a new registration number of class-C or class-D medical devices which are measuring devices in Vietnam?
- What are the cases of issuance of a new registration number of class-C or class-D medical devices which are measuring devices in Vietnam?
What is the application form for issuance of a new registration number of class-C or class-D medical devices which are measuring devices in Vietnam?
Pursuant to Appendix I promulgated together with Circular 10/2023/TT-BYT stipulating application form for issuance of a new registration number of class-C or class-D medical devices which are measuring devices as follows:
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What is the application form for issuance of a new registration number of class-C or class-D medical devices which are measuring devices in Vietnam? (Image from the Internet)
What is the application for issuance of a new registration number of class-C or class-D medical devices which are measuring devices in Vietnam?
Pursuant to the provisions of Article 30 of Decree 98/2021/ND-CP stipulates as follows:
Application for issuance of a new registration number
1. An application for issuance of a new registration number of a medical device without a national technical regulation consists of:
a) The application form for issuance of a new registration number.
b) An unexpired certificate of conformity with ISO 13845 quality control standards.
c) The unexpired letter of authorization given by the product owner to the organization that applies for registration, except the case specified in Point a Clause 1 Article 25 of this Decree.
d) The certificate of eligibility to provide warranty granted by the product owner, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty.
dd) The unexpired CFS (for imported medical devices).
e) ASEAN Common Submission Dossier Template (hereinafter referred to as “CSDT”).
g) Certificate of conformity.
2. An application for issuance of a new registration number for the medical device that is a measuring device whose sample requires approval as prescribed by the law on measurement consists of:
a) The application form for issuance of a new registration number.
b) Decision on approval of the sample medical device.
c) The documents specified in Points b, c, d, dd and e Clause 1 of this Article.
3. An application for quick issuance of a new registration number for the medical device as prescribed in Clause 2 Article 29 of this Decree consists of:
a) The application form for issuance of a new registration number.
b) The documents specified in Points b, c, and d Clause 1 of this Article.
c) The CFS issued by one of the reference countries in the case prescribed in Point a Clause 2 Article 29 of this Decree.
d) The CFS of the imported medical device and import license or registration number or certificate of registration in the case prescribed in Point b Clause 2 Article 29 of this Decree.
dd) Certificate of quality assessment issued by a competent authority of Vietnam for IVD medical device, except the following cases:
- The medical device is included in List A or List B of Annex 2 of the European Union Regulation of In Vitro Diagnostic Medical Devices and has been granted CFS by one of EU Member States, UK or Switzerland;
- The medical device is included in List A or List B of Annex 2 of the European Union Regulation of In Vitro Diagnostic Medical Devices and has been granted the Marketing Authorization by one of the reference countries;
- The medical device is not included in List A or List B of Annex 2 of the European Union Regulation of In Vitro Diagnostic Medical Devices but has been granted the Marketing Authorization by one of the reference countries;
- The medical device is included in the list of medical devices announced by the Minister of Health.
e) The CSDT.
.....
Accordingly, an application for issuance of a new registration number for the medical device that is a measuring device whose sample requires approval as prescribed by the law on measurement consists of:
- The application form for issuance of a new registration number.
- Decision on approval of the sample medical device.
- An unexpired certificate of conformity with ISO 13845 quality control standards.
- The unexpired letter of authorization given by the product owner to the organization that applies for registration, except the case specified in Point a Clause 1 Article 25 of this Decree.
- The certificate of eligibility to provide warranty granted by the product owner, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty.
- The unexpired CFS (for imported medical devices).
- ASEAN Common Submission Dossier Template (hereinafter referred to as “CSDT”).
What are the cases of issuance of a new registration number of class-C or class-D medical devices which are measuring devices in Vietnam?
Pursuant to the provisions of Clause 1, Article 29 of Decree 98/2021/ND-CP, as follows:
Methods of registration
1. A new registration number shall be issued in the following cases:
a) The medical device does not have any registration number.
b) The medical device has been granted registration number but has any of the following changes:
- A change in the product owner; class of the medical device; category, intended purposes or indications for use; quality standards; addition of factory or product code; raw materials that affect the functions of IVD medical device or disposable medical device; concentration, content, composition of raw materials that are active ingredients incorporated in the medical device to support in medical treatment;
- A change other than those specified in Clause 7 Article 32 of this Decree.
Accordingly, a new registration number shall be issued in the following cases:
- The medical device does not have any registration number.
- The medical device has been granted registration number but has any of the following changes:
+ A change in the product owner; class of the medical device; category, intended purposes or indications for use; quality standards; addition of factory or product code; raw materials that affect the functions of IVD medical device or disposable medical device; concentration, content, composition of raw materials that are active ingredients incorporated in the medical device to support in medical treatment;
+ A change other than those specified in Clause 7 Article 32 of this Decree 98/2021/ND-CP.
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