What is the latest form of synopsis of technical description of the imported medical device for issuance of registration number in Vietnam?
- What is the latest form of synopsis of technical description of the imported medical device for issuance of registration number in Vietnam according to Circular 10/2023/TT-BYT?
- What are the contents of synopsis of technical description of the imported medical device for issuance of registration number in Vietnam?
- What are the conditions for placement of medical devices on the market in Vietnam?
What is the latest form of synopsis of technical description of the imported medical device for issuance of registration number in Vietnam according to Circular 10/2023/TT-BYT?
Pursuant to Form No. 04, Appendix VIII issued with Circular 10/2023/TT-BYT, stipulating the form of synopsis of technical description of the imported medical device for issuance of registration number is as follows:
Download the form of synopsis of technical description of the imported medical device for issuance of registration number: Click here.
What is the latest form of synopsis of technical description of the imported medical device for issuance of registration number in Vietnam?(Image from the Internet)
What are the contents of synopsis of technical description of the imported medical device for issuance of registration number in Vietnam?
Pursuant to Form No. 06, Appendix VIII issued together with Circular 10/2023/TT-BYT, stipulating the content of a synopsis of technical description of the imported medical device for issuance of registration number, including:
- Product description of medical device:
Brief description of the operating principle and features and technical parameters of the equipment; stating that if the device uses new technologies, a description of the new technology (e.g. nanotechnology) should be provided.
- Catalog of components and accessories
List the components and accessories of medical device
- Purpose/Indications for use
State the purpose of use/indications for use of the medical device
- User manual
Summary of instructions on how to use the device according to the Instructions for Use or Information Sheet of the medical device
- Contraindications
Information on contraindications - i.e. situations where the use of the device is not indicated for the safety of the patient, for example due to medical history, physiological characteristics of the patient, etc...; in accordance with the approved content in the country of circulation and stated on the label of the medical device
- Warning and caution
Warning information and points of caution when using medical device, including preventive measures to protect patients from risks caused by the use of medical device; It may be information about adverse effects or misuse and precautions
- Possible adverse effects
Information on medical device-related adverse events recorded in clinical trials and post-marketing follow-up previously performed for the medical device
- Information on products that have been circulated in other countries (if any)
Provide information about the countries that have approved the marketing authorization of the product, the first country to grant registration/permit the circulation of medical device
- Designations registered in other countries (if any)
List the countries where marketing registration has been issued with the indication for use approved in that country; date of grant of registration
- Information on the safety/remarkable operation of medical device products
+ Provide information on the number of reports of adverse reactions related to the use of the medical device; Post-marketing recall/adjustment measures have been implemented at the request of the regulatory authorities of the countries;
+ If the medical device contains one of the following ingredients, it is necessary to provide information about:
++ Human or animal cells, tissues or their derivatives intended for use in a non-viable form - eg artificial heart valves of pig origin, cat intestine...;
++ Cells, tissues and/or derivatives of microbial or recombinant origin - eg skin plumping products based on hyaluronic acid obtained by bacterial fermentation...; Contains irritating, ionizing ingredients - eg X-ray; or non-ionizing - E.g. laser, ultrasonic...
- Report on clinical evaluation for class C, D medical devices other than in vitro diagnostic medical devices
What are the conditions for placement of medical devices on the market in Vietnam?
Pursuant to the provisions of Article 22 of Decree 98/2021/ND-CP (amended by Clause 2, Article 1 of Decree 07/2023/ND-CP) as follows:
Conditions for placement of medical devices on the market
1. A medical device may be placed on the market if it meets the following conditions:
a) It has been granted registration number, marketing authorization number, certificate of registration or import license in accordance with regulations on management of medical devices or in the cases specified in Point d Clause 2 Article 76 of this Decree, except the following cases:
- The medical device is liquidated as prescribed by laws;
- The medical device reaches its expiry date;
- The defect that is harmful to users’ health cannot be repaired as prescribed in Clause 4 Article 34 of this Decree;
- The use of medical device is prohibited by a regulatory authority.
b) Its label contains adequate information in accordance with regulations of law on labeling of goods;
c) Instructions for use of the medical device are given in Vietnamese language;
d) Information about warranty center, conditions and time for warranty, except disposable medical devices defined by the product owner or cases where there are documents proving that the medical device is not under warranty.
2. If the import license is available as prescribed in Points a, b, c, d and dd Clause 1 Article 48 of this Decree, the satisfaction of the condition in Point d Clause 1 of this Article is not required.
3. If the information specified in Point c and Point d Clause 1 of this Article is not provided upon the medical device itself, it must be provided in the form of electronic information for which instructions for search must be available on the label of the medical device
Accordingly, when circulating medical device must meet the above conditions.
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