Tiếng Việt
The procedure for importing medical equipment is quite complicated, as it is often related to equipment classification and import permits. I want to detail in this article for your reference.
Some main contents:
- Procedures for classifying medical equipment (into categories A, B, C, and D)
- Procedures for registration of free sale of medical equipment
- Procedures for applying for a medical device import license (only for categories B, C, D)
- Procedures for importing medical equipment
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What is medical equipment?
Simply put, it can be understood as machinery, equipment, tools… serving the medical field.
But to have a more precise concept, you need to see the quote from Article 2 – Circular 30/2015/TT-BYT:
Medical equipment is all types of equipment, tools, supplies, in-vitro diagnostic chemicals, and software used individually or in combination with each other as directed by the owner to serve to humans for one or more of the following purposes:
Diagnose, prevent, monitor, treat and alleviate disease or injury;
Test, replace, adjust or support anatomy and physiological processes;
Support or sustain life;
Control conception;
Disinfection of medical equipment (excluding chemicals, insecticidal and antibacterial preparations used in the household and medical fields);
Use for medical equipment;
Specialized transportation for medical activities.
Classification of medical equipment
When importing medical equipment, you must check to see which type of equipment is: A, B, C, or D according to Article 4 of Decree 36/2016, and Circular 39/2016/TT-BYT. ? Depending on the type, you will know what procedures must be followed.
Specifically: From January 1, 2018, importers must carry out procedures to announce standards applicable to type A medical equipment; and Procedures for registration for circulation of type B, C, D medical equipment.
Type A: Must obtain a Medical Device Classification Form
Type B, C, D: In addition to the Classification as above, the importer must also apply for an Import License, if the goods are on the list that requires a license in Circular 30/2015. Below is the section related to the List of licenses required and procedures for goods of types B, C, D.
Procedures for classifying medical equipment:
Step 1: Prepare a profile, including the following documents:
Written request for medical equipment classification
Technical documents (catalogs) describe the functions and technical specifications of medical equipment
Instructions for use of medical equipment
The standard that the medical equipment manufacturer announces to apply
Certificate of quality management standards is still valid
Certificate of classification and free circulation; Certificate of conformity (if any)
Step 2: Submit documents to the Institute of Medical Equipment and Construction.
Step 3: Wait for feedback, add corrections if necessary
Step 4: Receive classification results
Imported goods must be registered for circulation. In addition, for goods of type B, C, D, in addition to the above classification, you need to apply for an import license if you are on the list that requires a license.
Procedures for registration of circulation of medical devices
To import and circulate foreign medical equipment that does not have a circulation number in Vietnam, businesses need to carry out procedures to request a new circulation number for imported medical equipment. Regulations in Chapter IV of Decree 36/2016/ND-CP (from Article 17).
The importer prepares documents to submit to the Ministry of Health, including:
Document requesting new issuance of circulation number;
Medical equipment classification;
Certificate of meeting quality management standards;
Power of attorney from the owner of the medical equipment for the facility to carry out the registration;
Certificate of warranty eligibility issued by the owner of the medical equipment;
Certificate of free circulation;
Documents describing technical summary of medical equipment in Vietnamese;
Technical documents (catalogs) describe the functions and technical specifications of medical equipment;
Instructions for use of medical equipment;
Label sample to be used when circulating in Vietnam of medical equipment.
In case of registration for circulation of medical equipment with corresponding national technical regulations, a Certificate of Conformity is required.
Procedures for applying for a license to import medical equipment
List of medical equipment requiring import license
This list is specified in Circular 30/2015/TT-BYT. In it, you can also learn about the authority, documents, and procedures for issuing licenses to import medical equipment. The Circular lists 49 types, divided into 2 groups:
Diagnostic equipment, such as X-ray machines, ultrasound machines, heart rate monitors…
Treatment equipment, such as: scalpels, anesthesia machines, dialysis equipment…
Now, if you know that the goods you intend to import require permission, what should you do?
Then you need to find out who issued it, what the documents are, and what steps are taken…
Authority to issue licenses to import medical equipment
The Minister of Health has the authority to decide on new issuance, extension, adjustment, re-issuance and revocation of medical equipment import licenses. The Minister can authorize the Deputy Minister and Director of the Department to sign licensing decisions (as shown).
Application for medical equipment import license
The application for a new import license includes the following main documents:
Application for new import license (according to form)
The certificate of free circulation is still valid
Valid certificate of ISO standards from the manufacturer.
Valid power of attorney from the owner of the medical equipment to the importer (according to Form).
Technical documents describing types of imported medical equipment in Vietnamese (according to Form)
The catalog describes the functions and technical specifications of the equipment type.
Clinical evaluation documents and user manuals of the owner or manufacturer for medical equipment
Report on results of import of medical equipment (according to form) in case the import license has expired without extension.
That is an application for a new license. For documents when you want to extend, adjust, or re-issue an import license, please refer to details in Articles 7, 8, 9 of Circular 30.
Procedures for applying for a license to import medical equipment
The new licensing procedure includes the following main steps:
Submit application for licensing at the Ministry of Health (Department of Medical Equipment and Constructions)
Waiting for the Department’s response
Add and edit records if necessary
License granted, if all documents are valid; or refused in writing, clearly stating the reason.
Details of each step are stated in Article 41 of Decree 36/2016/ND-CP, and Article 12 of Circular 30.
Note:
Official Dispatch 5464/BYT-TB-CT and 3593/BYT-TB-CT on medical equipment management from July 1, 2017, when importing, must have the results of medical equipment classification by issued by competent authority.
From January 1, 2018, the medical equipment import license will be replaced by the Standard Announcement Procedure applicable to type A medical equipment; and Procedures for registration for circulation of type B, C, D medical equipment
Look up the Ministry of Health import license on the National One-Stop Information Portal
Steps to carry out procedures for importing medical equipment
Apply for an import license (mentioned above)
Submit customs documents
Do customs clearance procedures
Regarding customs records, including main documents such as: Commercial invoice, Bill of Lading, Surcharge invoice… In addition, depending on the classification of goods, customs records supplement the following documents:
a) For medical equipment classified as type A:
Medical equipment classification according to the form or documents proving the results of medical equipment classification according to the provisions of Circular No. 42/2016/TT-BYT dated November 15, 2016 regulating the recognition of medical equipment classification results. Medical equipment classification results.
Authorization letter of the circulation number owner (if the importer is not the circulation number owner).
b) For medical equipment classified as types B, C, D and on the list attached to Circular No. 30/2015/TT-BYT, additional payment must be made:
Import license from the Ministry of Health according to Circular 30/2015/TT-BYT;
Medical equipment classification
c) For medical equipment classified as types B, C, D and not included in the list of medical equipment issued in Circular 30/2015/TT-BYT, the importer must provide additional information. Medical equipment classification
To learn the steps to clear customs procedures for imported medical equipment, read the article “Customs Procedures” for more details.
Or if you want to find a customs service unit, send information via the link below, I will contact you soon. Here I would like to end the article on medical equipment import procedures.
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