Service on Publication of Applicable Standards of Type A Medical Equipment

Before releasing type A medical equipment, the establishment in charge of selling medical equipment shall send the declaration of applicable standard specified in Article 22 of Decree No. 36/2016/ND-CP to the Department of Health of the area where such establishment is headquartered;

Service description

Step 1: Before releasing type A medical equipment, the establishment in charge of selling medical equipment shall send the declaration of applicable standard specified in Article 22 of Decree No. 36/2016/ND-CP to the Department of Health of the area where such establishment is headquartered;

Step 2: If the declaration is satisfactory, the Department of Health shall issue the establishment with the Receipt note using the form No. 03 in Annex IV enclosed with Decree No. 36/2016/ND-CP;

Step 3: Within 03 working days from the date written on the receipt note, the Ministry of Health shall publish the following information on its web portal: name, classification, producer, country of origin of medical equipment; registration number of free sale of the medical equipment; name, address of the owner of the medical equipment; name, address of the holder of the registration number; name, address of the establishment providing warranty services on medical equipment and the declaration of applicable standard for medical equipment.

Document Components

1. A declaration of the applicable standard of type A medical equipment using the form No. 03 provided in Annex I enclosed with Decree No. 36/2016/ND-CP.
2. A classification table using the form in Annex V enclosed with this Decree.
3. A receipt note of the declaration of eligibility to produce medical equipment, applicable to domestically produced equipment, or the Certificate of conformity with quality control standards which is effective by the time of declaration, applicable to imported equipment.
4. The power of attorney by the owner of the medical equipment for the organization declaring the applicable standard using the form in Annex VI enclosed with this Decree which is effective by the time of declaration, except for cases specified in point a clause 1 Article 21 of this Decree.
5. The certificate of eligibility to provide warranty issued by the owner of the medical equipment using the form provided in Annex II enclosed with this Decree, excluding disposable medical equipment prescribed by its owner.
6. Documents that give brief description of medical equipment technology using the form No. 01 in Annex VIII enclosed with this Decree.
7. The standard which the owner of the medical equipment declares to apply or the Certificate of conformity.
8. Written instruction for the medical equipment.
9. The label of the medical equipment which is intended to be used when it is sold in Vietnam.

The Values Ha Le provides

• Consultancy on publication of applicable standards
• Consultancy on preparations of documents and information to complete publication of applicable standards of type A medical equipment;
• Compose and prepare related documents;
• Represent business to conduct procedures of publication of applicable standards of type A medical equipment at competent authorities;
• Discuss and provide information to customers in the process of declaration;

Please contact for further consultancy and detailed quotation!