Conditions for buying and selling type A medical equipment

Conditions for buying and selling type A medical equipment specifically regulated by law. When all conditions are met, it will ensure the legal and effective purchase and sale of medical equipment. This article will provide detailed information about the conditions for buying and selling type A medical equipment as well as standard declaration procedures.

What is Class A medical equipment?

According to Article 4 of Decree 98/2021/ND-CP, medical equipment is classified based on risk level, including type A (low risk), type B (medium risk), type C (high risk) and type D (very high risk). Class A medical equipment is the group with the lowest risk level. This classification is important in determining the management, registration and circulation requirements for each type of device.

Conditions for buying and selling type A medical equipment

Medical equipment business is a conditional business. Conditions for trading of type A medical equipment are associated with conditions for registration of circulation of medical equipment as prescribed in Article 25 of Decree 98/2021/ND-CP. Specifically as follows:

1. Organizations authorized to announce applicable standards or register for circulation of medical devices include:

• Vietnamese enterprises, cooperatives, and business households are the owners of medical equipment;
• Vietnamese enterprises, cooperatives, and business households authorized by medical equipment owners;
• Representative office residing in Vietnam of a foreign trader that is the owner of the medical device or authorized by the owner of the medical device.

2. The organization declaring applicable standards or registering for circulation of medical equipment must have a warranty facility in Vietnam or must have a contract with an organization qualified to warranty medical equipment, except in the case of single-use medical equipment or documents proving that there is no warranty.

In case the organization announces the applicable standards or registers the circulation of medical equipment as prescribed in Point c, Clause 1 of this Article, the owner of the medical equipment must have a warranty facility in Vietnam or must have a contract with a facility qualified to warranty the medical equipment, except in the case of single-use medical equipment or documents proving that there is no warranty.

The warranty facility must be certified by the medical device owner as qualified to provide product warranty.

Procedures for declaring standards for class A medical devices

Standard publication dossier

Pursuant to Article 26 of Decree 98/2021/ND-CP, standard declaration documents for type A equipment include:

• Document announcing applicable standards of type A medical equipment;
• Certificate of ISO 13485 quality management standards still valid at the time of application;
• Power of attorney from the medical device owner to the organization declaring the applicable standards is still valid at the time of application submission;
• Certificate of warranty eligibility issued by the owner of the medical device, except in the case of single-use medical equipment or documents proving that there is no warranty;
• Documents describing the technical summary of the medical equipment in Vietnamese, accompanied by technical documents describing the functions and technical specifications of the medical equipment issued by the owner of the medical equipment;
• Particularly for reagents, calibrators, and in vitro control materials: technical documents in Vietnamese accompanied by documents on raw materials, product safety, production processes, clinical and pre-clinical research reports including stability reports;
• Certificate of conformity according to regulations or product standard published by the medical device owner;
• Particularly for domestically produced medical equipment, supplement the results of assessment of chemical, physical, microbiological and other parameters issued by a qualified facility according to the provisions of law on conformity assessment or Certificate of quality assessment issued by a competent Vietnamese agency for in vitro diagnostic medical equipment;
• Instructions for use of medical equipment;
• Label sample to be used when circulating in Vietnam of medical equipment;
• The certificate of free circulation is still valid at the time of application submission for imported medical equipment.

Announcement procedures

According to the provisions of Article 28 of Decree 98/2021/ND-CP promulgating standards for type A medical equipment including the following steps:

Step 1: Submit application

Submit application for declaration of standards to the Department of Health where the business is located.

Step 2: Upload the standard publication number

Upon receiving the dossier, the Department of Health posts the applicable standard publication number for type A medical equipment publicly on the Electronic Information Portal on medical equipment management and the applicable standard declaration dossier.

Consulting services on conditions for buying and selling type A medical equipment in Long Phan

Long Phan provides professional consulting services on conditions for purchasing and selling Class A medical equipment, including:

• Consulting on conditions for buying and selling type A medical equipment;
• Consulting and supporting the drafting of standard declaration documents for type A medical equipment;
• Instructions on the procedure for declaring standards for type A equipment;
• Consulting and guidance on supplementing documents (if any);
• Consulting on cases of notification of standard changes;
• Consulting and guiding the process of notifying standard changes
• Consulting and answering other related issues.

Complying with the conditions for buying and selling type A medical equipment is a necessary factor for organizations and individuals operating in this field to comply with the law and ensure safety for users. Hopefully this article has provided customers with useful information. If you have any questions, please contact the hotline: 0906735386 for advice and support.