PROCEDURES FOR IMPORTING MEDICAL DEVICES
The procedure for importing medical equipment is one of the complicated procedures but the demand is great. Imported medical equipment may have procedures such as classification of medical equipment, registration for circulation of medical equipment, publication or even application for a license when importing medical equipment of group B, C , D.
The One Logistics will specify the above procedures in the article for you to understand.
Main contents of procedures for importing medical equipment:
- Procedures for classifying medical equipment for types A, B, C and D.
- Procedures for registration of circulation of medical devices is from 2022.
- Procedure of applying for medical equipment import permit (for types B, C and D only).
- Procedures for importing medical equipment
What is medical equipment?
According to Article 2 - Circular 30/2015 / TT-BYT:
Medical equipment means all kinds of in-vitro diagnostic equipment, instruments, chemicals, diagnostic chemicals, software used separately or in combination with the owner's designation to serve for humans for one or more of the following purposes:
- Diagnosis, prevention, monitoring, treatment and mitigation of disease or injury compensation;
- Check, replace, adjust or support anatomy and physiological process;
- Support or sustain life;
- Control conception;
- Disinfecting medical equipment (excluding chemicals, insecticidal and germicidal preparations for domestic and medical use);
- Use for medical equipment;
- Specialized transportation for medical activities.
Classification of medical equipment
What sort of medical equipment does our company plan to import? This is the question that The One Logistics is most asked when consulting on classification of medical equipment.
So, in order to know what kind of medical equipment we intend to import, what do we need to do? The answer is that you should refer to Article 4 of Decree 36/2016, and Circular 39/2016 / TT-BYT.
For this procedures from 2018, importers must carry out procedures for announcing the standards applicable to medical equipment of categories A and procedures for registration of circulation with medical equipment of categories B, C and D in 2020.
- Type A: Get the medical classification using the form issued by the Ministry of Health.
- Types B, C, D: We need to compare with the list of medical equipment in Circular No. 30/2015 / TT-BYT dated 12 October 2015 providing for the import of medical equipment, to know if your item is intended to be imported when you need it when you import it.
Procedures for classifying medical equipment:
- Application for classification of medical equipment.
- Business registration certificate or investment certificate (certified copy).
- A valid certificate of ISO 13485 or ISO 9001 international quality management standard and the valid duration of the manufacturing firm or country.
- Certificate of free sale (CFS - Certificate of Free Sale) in the country of production is valid and valid (the original or consular legalization certificate).
- A power of attorney from the manufacturer or a legal distributor for the importer authorized to import and distribute medical equipment and products in Vietnam is valid and valid (the original or the certificate consular legalization).
- Description of product (Catalog) of imported medical equipment (a copy certified by the importing unit).
- Technical documents describing imported medical equipment and products.
Procedures for registration of circulation of medical equipment apply from 2022
The importer shall submit an application to the Ministry of Health including:
- A written request for a new circulation number;
- Classification of medical equipment;
- Certificate of quality management standard ISO 13485 or ISO 9001;
- Power of attorney of the medical equipment owner to the facility to carry out the registration;
- Certificate of eligibility for warranty issued by the owner of the medical equipment;
- CFS free circulation certificate;
- Brief description document of medical equipment in Vietnamese;
- Technical documents (catalog) describing the functions and specifications of medical equipment;
- Documentation of the use of medical equipment;
- The sample of labels to be used when circulating in Vietnam of medical equipment.
In case of registration for circulation of medical equipment with the respective national technical regulations, a regulation conformity certificate is required.
Procedures for medical device import license
When the results of classifying medical devices are B, C, D, we may need to apply for an import license. The list of medical equipment required to have an import license when carrying out customs procedures is specified in Appendix I of Circular No. 30/2015 / TT-BYT of October 12, 2015.
List of medical equipment subject to import license
According to Circular No. 30/2015 / TT-BYT dated 12/10/2015, this list is divided into 2 groups:
1. Diagnostic equipment: Diagnostic equipment with images, ultrasound, endoscopy or other types of meters ...
2. Treatment equipment: System of treatment equipment, infusion pump, scalpel, microscope ...
An application for a medical device import license according to Circular No. 30/2015 / TT-BYT:
1. A written request for a new import permit, made according to Form No. 01 provided in Appendix II to this Appendix.
2. A valid certificate of free circulation for the category of imported medical equipment.
3. The certificate of manufacturer's conformity with the international quality management system standard ISO 13485 or ISO 9001.
4. The authorization letter of the owner of the medical equipment for the importer of medical equipment (according to the Form prescribed in Appendix III to this Circular) is still valid at the time of submission. Profile.
5. Technical documents describing the category of imported medical equipment in Vietnamese using the form specified in Appendix IV issued with this Circular.
6. Cataloge describes the functions, specifications of the category of imported medical equipment.
7. Clinical evaluation documents and instruction manuals of the owner or manufacturer of medical equipment (if the imported equipment is in section 49 of Appendix I issued with the Circular this).
Procedures for medical equipment import license
The new licensing procedure includes the following main steps:
- Submit application for permission at the Ministry of Health (Department of Medical Equipment and Facilities)
- Ministry of Health - The Department of Council's medical equipment and facilities contract, request amendments to the documents if necessary, or consider granting import licenses.
- Additional corrected records if the Department of equipment and facilities required
- Be granted a license, if the dossier is complete and valid; or denied in writing, clearly stating the reason.
With The One Logistics, always advising customers on what to do and the most accurate, one of them is to read carefully the Circular 30/2015 / TT-BYT because it details but is very short, very easy to understand. , easy to read.
Customs dossiers when carrying out procedures for importing medical equipment:
- Import customs declaration.
- Commercial invoice.
- Packing list (if any)
- Catalog and technical description if available.
- Classify medical devices and announce standards for class A medical equipment, and import licenses if Class B and equipment are on the list of those that require a license.
- Bill of lading.
- C / O if available.
Summarizing the article, the steps to follow procedures for importing medical equipment include:
- Classification of medical equipment.
- Publish medical equipment if needed.
- Obtain medical equipment import license if needed.
- Import customs declaration
- Customs clearance procedures
For details on medical equipment, please contact us via Hotline: 0973.266.672 Mr. Thang. The One Logistics provides a full range of services related to classification, publication, licensing and import customs clearance for medical equipment.
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