Guide to Applying for a Certificate of Fulfillment of Conditions for Trading Medical Equipment

Conditions for Trading Medical Equipment and Devices

Trading medical equipment and devices is a conditional business type. Before engaging in this business, in addition to meeting the necessary conditions of registering a business with the business line as prescribed by the Law on Enterprises, enterprises must also meet the following sufficient conditions for trading medical equipment and devices (MEDs) before being allowed to operate in this field. They are only allowed to trade MEDs that have been granted a circulation license by the Ministry of Health.

Thien Di would like to guide you through the procedures for applying for a certificate of eligibility to trade medical equipment and devices in the following article:

1. Legal basis for the procedure

Law on Commerce;
Law on Enterprises;
Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on the Management of Medical Equipment and Devices, amended and supplemented by Decree No. 169/2018/ND-CP.

2. What is Medical Equipment?

According to Decree No. 36/2016/ND-CP and its amendments in Decree No. 169/2018/ND-CP, "Medical equipment" is specifically defined as any device, instrument, material, implant, in vitro reagent or calibrator, software, etc. that meets specific requirements, such as:

- The equipment is used alone or in combination, as specified by the owner of the medical equipment, for the following purposes:

To diagnose, prevent, monitor, treat, and alleviate diseases, and to compensate for human injuries and trauma.
To test, replace, adjust, and support human anatomy and physiology.
To support or sustain human life.
To control conception.
To sterilize other related equipment.
Medical equipment is also used to provide necessary and useful information for the testing, diagnosis, monitoring, and treatment of patients by testing and analyzing samples from the human body.

- Medical equipment does not work through pharmacological, immunological, or metabolic mechanisms in or on the human body. If it does use these mechanisms, it is only for supportive purposes and must meet specific regulations.

3. What is a Medical Equipment Business Activity?

A medical equipment business activity is defined as the act of buying, selling, distributing, exporting, and importing one or more of the medical equipment items listed above, providing these items to consumers for profit.

The medical equipment business activity is different from the medical equipment manufacturing sector. In the manufacturing sector, medical equipment products are either directly manufactured by the factory or, if not directly manufactured, the factory still owns the product and hires another qualified manufacturing unit to process it. In contrast, the medical equipment business activity is the act of buying and reselling products to make a profit from that activity itself. Currently, in terms of conditions, the requirements for manufacturing medical equipment are more stringent than those for trading medical equipment. Therefore, not all entities are qualified to manufacture certain products. However, medical equipment trading companies have customers and markets, and they also have manufacturers to supply them with goods. According to current regulations, these business activities must go through the procedure of applying for a medical equipment business license (also known as the procedure for applying for a license to meet the conditions for buying and selling medical equipment of types B, C, and D).

4. Why is it necessary to apply for a medical equipment business license?

According to regulations, before engaging in the business of medical equipment of types B, C, and D, the head of the medical equipment business establishment is responsible for submitting a declaration of eligibility for business operation to the Department of Health where the business is headquartered. The business establishment is only allowed to trade in medical equipment of types B, C, and D after completing the declaration of eligibility for business operation procedure.

5. In which cases is it necessary to apply for a medical equipment business license?

- Currently, according to regulations, only establishments that trade in medical equipment of types B, C, and D need to apply for a medical equipment business license. If an enterprise trades in medical equipment of type A, it does not need to apply for a medical equipment business license.

- To determine whether medical equipment belongs to type A, B, C, or D, it is necessary to rely on the classification results. Before applying for a medical equipment business license, the business establishment must have a list of the medical equipment it intends to trade. If the list contains any product of type A, B, C, or D, the business establishment must apply for a medical equipment business license.

- The classification of medical equipment into types A, B, C, and D will be carried out by an establishment with sufficient conditions for medical equipment classification. The classification is based on the records and documents of the medical equipment product. The classification result is the basis for determining whether the establishment needs to apply for a Certificate of Eligibility for Medical Equipment Business Operation.

6. Conditions for obtaining a medical equipment business license in Vietnam:

6.1. For organizations performing medical equipment classification:

CONDITIONS FOR ORGANIZATIONS PERFORMING MEDICAL EQUIPMENT CLASSIFICATION:

6.1.1. Conditions for organizations performing medical equipment classification:

a) Legally established in accordance with the law;

b) Have personnel performing medical equipment classification meeting the conditions specified in Clause 2 below.

6.1.2. Conditions for personnel performing medical equipment classification:

a) Have a university degree in engineering or medicine, pharmacy or higher;

b) Have at least 24 months of direct experience in medical equipment engineering at hospitals, clinics with beds, medical equipment training institutions, medical equipment research institutions, medical equipment manufacturing facilities, medical equipment classification organizations, medical equipment management agencies (hereinafter referred to as medical equipment facilities);

c) Have been tested and certified by the training institution as competent to classify medical equipment according to the training program issued by the Ministry of Health.

An organization can only classify medical equipment after receiving a receipt of a dossier declaring eligibility for medical equipment classification from the Ministry of Health according to Point b, Clause 1, Article 9 of Decree 36/2016/ND-CP.

DOSSIER DECLARING ELIGIBILITY FOR MEDICAL EQUIPMENT CLASSIFICATION:

6.2.1. The dossier declaring eligibility for medical equipment classification includes:

a) Declaration of eligibility for medical equipment classification form;

b) Personnel list form; attached with confirmation of working time and diplomas, certificates of training of each person performing medical equipment classification.

6.2.2. Requirements for some documents in the dossier:

a) Original or certified copy of the confirmation of working time;

b) Certified copies of diplomas, certificates of training of each person performing medical equipment classification.

6.2. REQUIREMENTS FOR MEDICAL DEVICE MANUFACTURING FACILITIES

Human Resources Requirements:

For the technical supervisor:

a) Have a college degree or higher in medical equipment engineering or a bachelor's degree in engineering, medicine, or pharmacy;

b) Have at least 24 months of experience working directly in medical equipment engineering at medical equipment facilities;

c) Work full-time at the manufacturing facility. The assignment and appointment of the technical supervisor of the manufacturing facility must be documented in writing.

Have a team of employees that meets the production requirements for the type of medical device that the facility manufactures.

Physical Facilities, Equipment, and Quality Management Requirements:

Have a location, area, and production workshop suitable for the type of medical device that the facility manufactures.
Have equipment and production and quality control processes suitable for the type of medical device that the facility manufactures. If the facility does not have quality control equipment, it must have a contract with a qualified quality control facility to inspect the quality of the medical devices that the facility manufactures.
Have a warehouse that meets the following minimum requirements:

a) Have an area suitable for the types and quantities of medical devices to be stored;

b) Ensure that it is well-ventilated, dry, clean, and not near sources of pollution;

c) Meet other storage requirements for medical devices according to the instructions for use.

Have a means of transporting medical devices from the manufacturing facility to the delivery location that is suitable for the type of medical device that the facility manufactures.
Implement a quality management system according to Clause 1, Article 68 of Decree 36/2016/ND-CP.
If the facility does not have a warehouse or means of transporting medical devices, it must have a contract with a facility that meets the requirements for warehousing and transporting medical devices according to regulations.

DOCUMENTS FOR DECLARATION OF SUITABLE CONDITIONS FOR MEDICAL DEVICE MANUFACTURING

The dossier for declaring sufficient conditions for medical device manufacturing includes:

Declaration of sufficient conditions for manufacturing in the prescribed form
List of personnel in the prescribed form.
Document assigning and appointing the technical supervisor of the manufacturing facility, accompanied by a confirmation of the working time in the prescribed form and the diplomas and certificates of training of the technical supervisor.
Certificate of compliance with quality management standards.

If there is no certificate of compliance with quality management standards, there must be documents proving that the facility meets the requirements specified in Clauses 1, 2, 3, and 4 of Article 13 of Decree 36/2016/ND-CP.

If the facility does not perform self-inspection of product quality or does not have a warehouse or means of transportation and signs a contract for quality inspection, storage, and transportation with another facility, it must also attach documents proving that the facility is qualified to inspect the quality, warehouse, and transport the medical devices it manufactures.

6.3. Organizations Authorized to Declare Applied Standards or Register Circulation of Medical Devices

1. Organizations authorized to declare applied standards or register circulation of medical devices include:

a) Vietnamese enterprises, cooperatives, and business households that own the medical devices;

b) Vietnamese enterprises, cooperatives, and business households with the function of trading medical devices that are authorized by the owner of the medical devices to register;

c) Representative offices in Vietnam of foreign traders that are the owners of the medical devices or are authorized by the owners of the medical devices.

2. Organizations that declare applied standards or register circulation of medical devices must have a warranty facility in Vietnam or must have a contract with an organization that is competent to warrant the medical devices they register, except for cases of single-use medical devices according to the regulations of the owner of the medical devices.

In the case of organizations that declare applied standards or register circulation of medical devices as specified in Point c Clause 1 above, the owner of the medical devices must have a contract with an organization that is competent to warrant the medical devices they declare or register, except for cases of single-use medical devices according to the regulations of the owner of the medical devices.

The warranty facility must be certified by the owner of the medical device as being competent to warrant the product that the organization they represent requests a circulation number for.

6.4. For facilities buying and selling medical devices of types B, C, and D

Conditions for facilities buying and selling medical devices of types B, C, and D

Have a team of technical staff with appropriate qualifications to perform installation and instructions for use in accordance with the type of medical device that the facility buys and sells, including at least 01 technical staff with a college degree in engineering or medicine, pharmacy or college degree in medical equipment engineering or higher or a college degree or higher but the major studied is suitable for the type of medical device that the facility buys and sells.

Have a warehouse that meets the requirements specified in Clause 3, Article 13 of Decree 36/2016/ND-CP and have a means of transportation from the facility to the delivery location suitable for the requirements specified in Clause 4, Article 13 of Decree 36/2016/ND-CP, unless otherwise provided by law. In case there is no warehouse or means of transportation, there must be a contract with an organization that is competent to store and transport medical devices.

6.5. Export and Import of Medical Equipment

Conditions for Organizations and Individuals Importing Medical Equipment

Organizations and individuals importing medical equipment with existing circulation numbers must meet the following conditions:

a) Be the owner of the circulation number or have a written authorization from the owner of the circulation number. When authorizing an importer to import medical equipment, the owner of the circulation number must simultaneously send a copy of the authorization to the Ministry of Health and the customs authority.

b) Have a warehouse that meets the requirements of Clause 3, Article 13 of Decree 36/2016/ND-CP and have a means of transportation that meets the requirements of Clause 4, Article 13 of Decree 36/2016/ND-CP or have a contract with a facility with sufficient capacity to store and transport medical equipment.

The procedures for exporting and importing medical equipment shall comply with the regulations of the law on customs.

Importing organizations of medical equipment are not required to prove compliance with the above conditions when carrying out customs procedures.

6.6 Individuals Providing Technical Consultancy Services for Medical Equipment

1. Technical consultancy services on the listing, configuration, and technical specifications of medical equipment must be performed by individuals who have been granted a certificate of completion of training in medical equipment technical consultancy.

2. Conditions for individuals providing technical consultancy for medical equipment:

a) Have a university degree in engineering or medicine/pharmacy or higher;

b) Have at least 05 years of direct experience in medical equipment engineering at a medical equipment facility;

c) Have been tested and recognized by the training institution as competent to provide technical consultancy for medical equipment according to the training program issued by the Ministry of Health.

3. Consultants are only allowed to provide technical consultancy for medical equipment after the Ministry of Health has issued them a receipt of the dossier for the declaration of eligibility to provide technical consultancy for medical equipment in accordance with the regulations in Point b, Clause 2, Article 48 of Decree 36/2016/ND-CP.

4. Dossier for declaring eligibility to provide technical consultancy for medical equipment:

The dossier for declaring eligibility to provide technical consultancy for medical equipment includes:

a) Request for declaration of eligibility for consultancy in the prescribed form;

b) Certified copies of diplomas and certificates as prescribed in Points a and c, Clause 2, Article 47 of Decree 36/2016/ND-CP;

c) Confirmation of working time in the prescribed form;

6.7. Facilities for Medical Equipment Inspection and Calibration Services

Conditions for Public Announcement of Meeting the Requirements for Medical Equipment Inspection and Calibration

Human Resources Requirements:

Have at least two technical staff (officials or employees with fixed-term contracts of 12 months or more or indefinite-term contracts) meeting the following requirements:

a) Have a college degree in engineering or medicine, pharmacy or higher;

b) Have specialized knowledge suitable for the type of medical equipment that the person is assigned to inspect and calibrate.

Infrastructure and Equipment Requirements:

Have a laboratory. The laboratory must have a certificate of meeting the national standard for laboratory and calibration competence TCVN ISO/IEC 17025 or the international standard ISO/IEC 17025 (hereinafter referred to as the Certificate of meeting the laboratory and calibration standard).
The facility is only allowed to inspect and calibrate medical equipment after being issued a receipt of the dossier for public announcement of meeting the requirements for inspection and calibration by the Ministry of Health according to regulations in Clause 2, Article 52 of Decree 36/2016/ND-CP.

Dossier for Public Announcement of Meeting the Requirements for Medical Equipment Inspection and Calibration

Dossier for Public Announcement of Meeting the Requirements for Inspection and Calibration:

a) Request for public announcement of meeting the requirements according to Form No. 10 specified in Appendix I enclosed with Decree 36/2016/ND-CP;

b) List of personnel according to the form specified in Appendix II enclosed with Decree 36/2016/ND-CP;

c) Certificate of meeting the laboratory and calibration standard valid at the time of public announcement.

Requirements for the Dossier for Public Announcement of Meeting the Requirements for Inspection and Calibration:

a) The dossier for public announcement of meeting the requirements for inspection and calibration consists of 01 set, the documents in the dossier are clearly printed, arranged in order according to regulations in Clause 1 of this Article; there is a separation between documents, a cover page and a list of documents;

b) For the Certificate of meeting the laboratory and calibration standard: Submit the original or a certified copy or a copy certified by the organization that publicly announces the satisfaction of the conditions for inspection and calibration.

In case of submitting a copy certified by the organization that publicly announces the satisfaction of the conditions for inspection and calibration, when submitting the dossier, the original must be presented for comparison or the data source must be provided for the agency receiving the dossier to look up the validity of these documents.

In case the Certificate of meeting the laboratory and calibration standard is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to law.

7. Application for a Medical Equipment Business License

In addition to the Certificate of Business Registration with relevant business lines related to medical equipment trading, the application package for a medical equipment business license consists of 01 set of the following documents:

- Declaration of meeting the conditions for medical equipment trading

- Personnel declaration form

- Documents proving that the storage warehouse and transportation means for medical equipment meet the prescribed requirements. These documents must be verified by the establishment that has declared meeting the conditions for business.

- Documents proving that the storage warehouse and the tracking system for managing the process of exporting, importing, and inventorying medical equipment containing drugs and precursors meet the prescribed requirements. These documents must be verified by the establishment that has declared meeting the conditions for business of medical equipment containing drugs and precursors.

8. Procedures for applying for a medical equipment business license:

- Before trading medical equipment of types B, C, and D, the head of the medical equipment trading establishment is responsible for submitting the application for a certificate of meeting the conditions for trading medical equipment according to this Regulation to the Department of Health where the business is located.

- Upon receiving the application, the Department of Health shall issue a Receipt of Application for Declaration of Meeting the Conditions for Business to the establishment according to the Form.

- Within 03 working days from the date of receiving the application for declaration of meeting the conditions for business, the Department of Health is responsible for publicly disclosing on the electronic portal the following information: name and address of the medical equipment trading establishment; application for declaration of meeting the conditions for trading medical equipment.

- The establishment is only allowed to trade medical equipment of types B, C, and D after completing the procedures for applying for a medical equipment business license.

9. Do state agencies inspect medical equipment businesses on-site?

Unlike other procedures, before granting a license, the competent state agency will conduct an on-site inspection and appraisal of the business before issuing an operating license. For medical equipment business licensing procedures, the competent authority performs a post-inspection (i.e., inspection after) when applying for a medical equipment business license. And the business can only maintain the validity of its medical equipment business license if the state agency conducts an inspection and issues a conclusion report with satisfactory results.

Currently, the types of medical equipment businesses are very diverse, so each business needs to have appropriate facilities and equipment to serve the business items and products that the business is trading. Businesses also need to follow the regulations and specific instructions closely.

After completing the procedure for applying for a certificate of eligibility to trade in medical equipment (License for eligibility to buy and sell medical equipment types B, C, D), businesses need to prepare the following contents:

(i) The dossier as announced on the system when applying for a medical equipment business license;

(ii) Invoices and contracts proving the legal origin of imported goods;

(The facilities and warehouse must meet the conditions as prescribed in Decree 36/2016/ND-CP and Decree 169/2018/ND-CP with criteria such as: Business area, spacious and clean, equipment suitable for the company's business items. In addition, it is also necessary to comply with fire prevention and fighting regulations if the product is flammable or explosive).

10. What is the validity period of a medical equipment business license?

A medical equipment business license is valid indefinitely. Unless the State Agency requests the withdrawal and cancellation of the existing license due to violations by the business during the application process or during operation.

11. Thien Di's medical equipment business eligibility application service

Thien Di supports and consults clients on legal regulations related to the medical equipment business eligibility application procedure, and provides the following services:

Drafting dossiers and standardizing documents for clients;
Representing clients in performing related procedures at the competent State Agency;
Tracking the status of the application, receiving and returning results to the Client.

12. Reasons to choose Thiên Di's services:

Enthusiastic and timely customer support in all situations.

Our team consists of:

Experienced and professional experts and staff.
Regularly updated on new regulations and policies.
Continuously trained to improve professional skills and work experience.
Capable of handling high work pressure.
Always dedicated to self-improvement and professionalism, aiming for absolute customer satisfaction.

12.1. Human Resources

Human resources are the key to the success of any business. Therefore, Thien Di always focuses on building and developing a professional, serious, and customer-friendly human resource team - which has been the compass for our success over the past time.

Thien Di provides services for medical equipment import procedures, medical equipment classification services, application for medical equipment import licenses, import licenses for medical equipment, etc. in Vietnam. Currently, we provide this service in most provinces and cities across the country, completing the application and procedures on behalf of clients to submit to state agencies, so clients will not have to spend time doing administrative procedures.