What are the cases where domestically manufactured medical devices are granted emergency use registration number? What are the documents and procedures for that?
- What are the cases where domestically manufactured medical devices are granted emergency use registration number?
- What is the application for an emergency registration number for medical devices manufactured in Vietnam?
- What are the procedures for issuance of use registration number for medical devices manufactured in Vietnam in an emergency?
What are the cases where domestically manufactured medical devices are granted emergency use registration number?
According to the provisions of Clause 3, Article 29 of Decree 98/2021/ND-CP of Vietnam stipulating a number of cases where medical devices is granted emergency use registration number as follows:
“Article 29. Methods of registration
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3. Issuance of emergency use registration number for medical devices to serve epidemic prevention and control, and disaster recovery purposes in emergency cases included in the relevant List issued by the Minister of Health and in one of the following cases:
a) The medical device has been placed on the market or granted registration number for emergency use in one of the reference countries;
b) The medical device is included in the list of products for emergency use announced by the World Health Organization (WHO);
c) The medical device is included in the list of common products announced by the EU Health Security Committee (EUHSC);
d) The medical device has been granted the registration number or import license in the commercial form in Vietnam, unless revoked before the effective date of this Decree;
dd) The medical device is domestically manufactured in the form of technology transfer in one of the cases specified in Points a, b, c or d of this Clause;
e) The medical device is domestically manufactured in the form of processing in one of the cases specified in Points a, b, c or d of this Clause.”
According to the above regulations, there are 2 cases where medical device domestically manufactured is granted an emergency use registration number:
Device is domestically manufactured in the form of technology transfer or processing in one of the following cases:
- The medical device has been placed on the market or granted registration number for emergency use in one of the reference countries;
- The medical device is included in the list of products for emergency use announced by the World Health Organization (WHO);
- The medical device is included in the list of common products announced by the EU Health Security Committee (EUHSC);
- The medical device has been granted the registration number or import license in the commercial form in Vietnam, unless revoked before the effective date of this Decree.
What are the cases where domestically manufactured medical devices are granted emergency use registration number? What are the documents and procedures for that? (Image from the Internet)
What is the application for an emergency registration number for medical devices manufactured in Vietnam?
Pursuant to Clause 4, Article 30 and Clause 2, Article 31 of Decree No. 98/2021/ND-CP of Vietnam, the dossier is prepared as follows:
- The application form for issuance of a new registration number.
- The documents specified in Points b, c, and d Clause 1 of this Article.
- The CFS or license for emergency use of the imported medical device.
- The contract for technology transfer in the case prescribed in Point dd Clause 3 Article 29 of this Decree.
- The processing contract in the case prescribed in Point e Clause 3 Article 29 of this Decree.
- Certificate of inspection or certificate of quality assessment issued by one of the inspection/assessment bodies in the list published on the Ministry of Health’s website if the medical device falls in one of the following cases:
- The medical device is domestically manufactured;
- The medical device has been granted permit for placement on the market or emergency use by a competent authority of one of EU Member States, UK or Switzerland but is not included in the EUHSC’s list of common products.
- CSDT:
Documents issued by foreign competent authorities must be consularly legalized. Where a document does not bear consular legalization:
+ With regard to the letter of authorization: its original copy accompanied by certification shall be submitted.
+ With regard to the document specified in Point c Clause 4 Article 30 of this Decree: it must indicate the link for searching information on placement on the market or license for use of the medical device on the licensing authority’s website and be accompanied by a document providing the link for searching information of the applicant.
Information on placement of the device on the market found on the website must include at least the following information in English: name, category, manufacturer and manufacturing country.
What are the procedures for issuance of use registration number for medical devices manufactured in Vietnam in an emergency?
Receipt and processing of application for registration of medical devices according to the provisions of Clauses 4 and 6, Article 32 of Decree 98/2021/ND-CP of Vietnam as follows:
“Article 32. Receipt and processing of application for registration of medical devices
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4. With regard to an application for registration number for the medical device in the case prescribed in Clause 4 Article 30 of this Decree:
a) If the application is satisfactory, the Minister of Health shall process it within 10 days from the receipt of the adequate and valid application (including the application fee receipt as prescribed by the Ministry of Finance). If an application is refused, a written response indicating reasons for such refusal shall be provided.
The Ministry of Health shall only appraise the legal documents specified in Points b, c, d, dd and e Clause 4 Article 30 of this Decree. The applicant shall assume responsibility for the accuracy and legitimacy of other documents included in the application which may be inspected by the Ministry of Health after issuing the registration number.
b) If the application for registration number is not satisfactory, the Ministry of Health shall send a request for modification, in which such documents and contents requiring modification must be specified, to the applicant within 08 days from the receipt of the application.
c) The applicant shall comply with the request for modification and send modified documents to the Ministry of Health as requested.
If the modified application is still unsatisfactory, the Ministry of Health shall continue sending another request for modification to the applicant as prescribed in Point b Clause 4 of this Article.
If the applicant fails to provide the modified application within 90 days from the receipt of the Ministry of Health’s request for modification, the application shall be rejected.
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6. Within 01 working day from the issuance of the registration number, the Ministry of Health shall publish the following information on the Portal on management of medical devices, including:
a) Name, category, manufacturer and manufacturing country of the medical device;
b) Registration number of the medical device;
c) Name and address of the product owner;
d) Name and address of the registration number holder;
dd) Name and address of the warranty center;
e) The documents included in the application for registration of the medical device, except the documents specified in Point e Clause 1 and Point c Clause 5 of Article 30;
g) Intended purposes of the medical device.”
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