What do the procedures for importing medical equipment include?? What steps are included?? Join Cuong Quoc Logistics to find out details through the shares below.

Classification of medical devices

What is a medical device??

Medical devices are types of devices, tool, supplies, in-vitro diagnostic chemicals, software (software) used individually or in combination with each other as directed by the owner to serve humans for one or more of the following purposes::

• Diagnose, prevent, monitor, Treat and alleviate illness or compensate for damage, injury;
• Check, replace, regulate or support anatomy and physiological processes;
• Support and sustain life;
• Control conception;
• Disinfection of medical equipment, including chemicals used in the testing process;
• Provides information for diagnosis, monitor, Treatment is through examination of samples originating from the human body;
• Specialized transportation for medical activities.

To import medical-related machinery, Customs declarants need to carry out customs procedures for importing medical equipment according to the provisions of law.

Classification of medical devices

Medical devices can be divided into 4 types: A, B, C, D. In the process of importing medical equipment, Enterprises need to check the information in Circular 30/2015/TT-BYT, Circular 98/2021/ND-CP and Circular 05/2022/TT-BYT to know what type of device it is. Each type of equipment will have different import procedures.

Medical equipment classified Based on the level of potential risks associated with technical design and manufacturing, Therefore, medical equipment consists of 2 groups divided into 4 types:

GROUP	TYPE	LEVEL OF RISK	FOR EXAMPLE
Group 1	Type A	Short	Tongue depressor, banh, surgical forceps
Group 2	Type B	Low average	Needles, suction machine
	Type C	Average high	Ventilator, bone fixation splint
	Type D	Cao	From Tim, implantable defibrillator device

Classification of medical devices

The classification of medical equipment must be performed by a classification facility that declares applicable standards or registers for circulation.. To classify medical devices, Businesses need the following documents:

• Written request for medical equipment classification;
• Technical documents (catalogue) function description, 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)

Procedures for applying for a license to import medical equipment

Legal basis

Important legal bases for carrying out procedures to import medical equipment include::

• Decree 169/2018/ND-CP dated December 31, 2018 on amendments, Supplementing a number of articles of Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on medical equipment management;
• Circular 30/2015/TT-BYT dated October 12, 2015 issued by the Minister of Health regulating the import of medical equipment;
• Circular 14/2018/TT-BYT dated May 15, 2018 promulgating the list of medical equipment with product codes determined according to the list of exported goods, imported from Vietnam.
• Decree no 98/2021/ND-CP November 8, 2021 of the Government on medical equipment management
• Circular No. 05/2022/TT-BYT dated August 1, 2022 of the Minister of Health

List of medical devices requiring import license

This list of equipment is specified in Circular No. 05/2022/TT-BYT, Circular 30/2015/TT-BYT.

Authority to issue licenses to import medical equipment

The authority to issue medical equipment import licenses belongs to the Minister of Health. The Minister has the right to decide on new issuance, extend, adjust, reissue and revoke medical equipment import licenses.

Besides, The Minister can delegate authority to the Deputy Minister, The Director of the Department signs licensing decisions.

The agency directly carrying out the licensing of import of medical equipment is the Department of Medical Equipment and Constructions..

Application for medical equipment import license

The license application file includes::

• Document requesting new import license;
• Certificate of compliance with international quality management system standards ISO 13485 or ISO 9001 (or This is referred to as ISO certificate) Manufacturer's license is valid at the time of application;
• Technical documents describing the types of imported medical equipment in Vietnamese;
• Catalog describes functions, Technical specifications of imported medical equipment;
• Clinical evaluation documents and user manuals of the owner or manufacturer for medical equipment
• Power of attorney from the owner of the medical equipment to the organization, Individuals importing medical equipment.

Procedure for applying for a license to import medical equipment

The process of applying for a license to import medical equipment includes::

1. Organizations applying for medical equipment import licenses submit documents to the Ministry of Health (Department of Equipment and Missmedical program);
2. The Ministry of Health reviews the completeness, Validity of the application within 05 working days from the date of receipt of the application. In case the documents are incomplete, Valid for a period of 10 working days, from the date recorded on the application receipt form, The Ministry of Health must notify the importer in writing to make amendments, Supplement import documents;
3. In case the documents are complete, valid, The Ministry of Health is responsible for organizing meetings of the Advisory Council for issuance of medical equipment import licenses of the Ministry of Health (or This is referred to as the Advisory Council) to review and comment on the application for a new import license within 15 working days., from the date recorded on the application receipt form;
4. Within 15 working days, from the date of the Advisory Council meeting minutes, Based on the Minutes of the Advisory Council meeting, The Minister of Health reviews and decides to grant a license to import medical equipment. In case of refusal, there must be a written response clearly stating the reason.

Steps to carry out procedures for importing medical equipment

• Step 1: Apply for an import license (mentioned above);
• Step 2: Please announce the standards applicable to type A, B. Circulating with type C, D
• Step 3: Submit documents at the customs office;
• Step 4: Do customs clearance procedures.

About customs records, Includes key documents such as:: Commercial invoice, Bill of lading, Surcharge bill… Also, depending on product classification, which customs records add additional documentation or:

For medical equipment classified as type A, B

• Classification of medical equipment according to the form or documents proving the results of classification of medical equipment according to the provisions of Circular 98/2021/ND-CP regulates the recognition of medical equipment classification results;
• The standard announcement applies according to the provisions of Circular 98/2021/ND-CP

For medical equipment classified as type C, D and belongs to the attached list Circular No. 05/2022/TT-BYT and Circular 30/2015/TT-BYT, must pay more

• Import license from the Ministry of Health according to Circular 30/2015/TT-BYT and Circular No. 05/2022/TT-BYT;
• Circulation of type C medical equipment, D
• Medical equipment classification.

Conclude

With the above sharing about medical equipment import procedures, We hope that readers and businesses will have a clearer and more detailed view of the process and procedures during the application process.. If readers have questions that need answering, Please contact hotline 0972 66 71 66 for detailed advice..

Don't forget to update the latest news about Logistics on the website Logistics power!

Cuong Quoc Freight Forwarding Company Limited

Office: 7th floor, Parami Building, 140 Bach Dang, Tan Son Hoa Ward, Ho Chi Minh City

Hotline: 0972 66 71 66

Email: info@cql.com.vn

Website: https://cql.com.vn/