Thiên Di Provides Medical Device Classification Services

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Classification of Imported Medical Devices

1. What are Medical Devices?

According to Clause 1, Article 2 of Decree 36/2016/ND-CP on the management of medical devices, medical devices are defined as:

Medical devices are devices, equipment, materials, implants, in vitro test kits and calibrators, software, used alone or in combination as intended by the owner of the medical device to serve humans for one or more of the following purposes:

a) Diagnosis, prevention, monitoring, treatment, and palliation of diseases or injuries;

b) Examination, replacement, adjustment, or support for surgery and physiological processes;

c) Support or sustain life;

d) Control conception;

e) Disinfect medical devices, including chemicals used in the testing process;

f) Specialized transportation or use for medical activities;

g) Provide information for diagnosis, monitoring, and treatment by testing samples of human origin.

2. Regulations on Classification of Imported Medical Equipment

Legal Documents:

Decree No. 36/2016/ND-CP dated May 15, 2016, of the Government on the management of medical equipment; (amended and supplemented by Decree No. 169/2018/ND-CP dated December 31, 2018; Decree No. 03/2020/ND-CP dated January 01, 2020, the three decrees are consolidated into Consolidated Document No. 01/VBHN-BYT dated March 16, 2020)
Circular No. 39/2016/TT-BYT dated October 28, 2016, of the Ministry of Health detailing the classification of medical equipment;

Current Classification of Medical Equipment is regulated in Chapter II "Classification of Medical Equipment" of Decree No. 36/2016/ND-CP dated May 15, 2016, of the Government on the management of medical equipment, amended and supplemented in Clause 3, Article 1, Decree No. 169/2018/ND-CP dated December 31, 2018.

According to the above regulations, all medical equipment must be classified before being circulated. Except for cases that have been classified by the competent authority of the country that Vietnam recognizes based on international treaties or international agreements to which the Socialist Republic of Vietnam is a member or the country applies a medical device classification system similar to Vietnam.

The Minister of Health shall publish a list of countries that Vietnam recognizes the results of the classification of medical equipment.

3. Classification of Medical Devices

Medical devices are classified into two groups and four categories based on the potential risk associated with their design and manufacturing:

Group 1:

Type A: Low-risk medical devices.

For Group 1, businesses must declare the applicable standards before importing and trading.

Group 2:

Type B: Low-to-medium risk medical devices.
Type C: Medium-to-high risk medical devices.
Type D: High-risk medical devices.

For Group 2, businesses must also check Appendix I of Circular 30/2015/TT-BYT:

If the item is INCLUDED in Appendix I, a medical device import license must be obtained before importing.
Medical devices not included in the List of Appendix I attached to this Circular can be imported without an import license, but must still have documentation to ensure traceability of origin, provenance, and quality management of medical devices in accordance with legal regulations.

4. Medical Equipment Classified as Type A

Type A medical devices are considered low-risk. The current list of Type A medical devices includes the following:

- Equipment, tools, materials, implants, in vitro test kits and calibrators, and software that meet all of the following requirements:

+ They are used individually or in combination, as directed by the owner of the medical device, for one or more of the following purposes:

Diagnosis, prevention, monitoring, treatment, and palliation of disease or injury;
Testing, replacement, adjustment, or support of surgery and physiological processes;
Supporting or sustaining life;
Controlling conception;
Disinfecting medical devices, including chemicals used in laboratory testing procedures;
Providing information for diagnosis, monitoring, and treatment by testing samples from the human body.

- Type A medical devices do not include:

+ Low- to medium-risk medical devices;

+ Medium- to high-risk medical devices;

+ High-risk medical devices.

5. Principles of Medical Device Classification

(Clause 2, Article 4, Chapter II, Decree 36/2016/ND-CP dated May 15, 2016 of the Government on the management of medical devices, amended and supplemented in Clause 3, Article 1, Decree 169/2018/ND-CP dated December 31, 2018, and Circular 39/2016/TT-BYT detailing the classification of medical devices)

a) Classification of medical devices must be based on the risk classification rule and must be carried out by an establishment that has publicly announced that it meets the conditions for classifying medical devices according to the regulations in this Decree;

b) If a medical device has only one intended use, but that intended use can be classified into two or more different risk levels, the classification according to the highest risk level shall apply;

c) If a medical device has multiple intended uses and each intended use has a different risk level, the classification according to the highest risk level shall apply;

d) If a medical device is designed to be used in combination with another medical device, each medical device may be classified with a separate risk level, but the classification result must be based on the highest risk level of the final intended use of the combined medical device.

6. What type of medical device is a mask?

According to the Ministry of Health of Vietnam, masks are classified as Class A medical devices. This classification is based on the level of risk associated with the use of the device, with Class A being the lowest risk category.

The following table provides a more detailed breakdown of the different types of medical devices and their corresponding risk classifications:

No	Name of medical equipment	Product category/code	Manufacturer/Country of Manufacture	Brand/Owning Country	Intention for Use as Directed by Owner	The basis for classifying risk levels	Risk Level Classification
1	Worm hat	No	Leboo Healthcare Products Limited- China	Vinatoken Trading and Technology Company Limited - Vietnam	Using elastic to secure all of the hair	4	Medical Equipment Type A
2	Activated carbon mask	No	Leboo Healthcare Products Limited- China	Vinatoken Trading and Technology Company Limited - Vietnam	Dust-proof, Antibacterial, Chemical-resistant - Used in Factories, Workshops, Laboratories, Hospitals, Construction Sites, Daily Life,...	4	Medical Equipment Type A
3	Three-layer medical mask	No	Leboo Healthcare Products Limited- China	Vinatoken Trading and Technology Company Limited - Vietnam	Dust-proof, Antibacterial, Chemical-resistant - Used in Factories, Workshops, Laboratories, Hospitals, Construction Sites, Daily Life,...	4	Medical Equipment Type A
4	Four-layer medical mask	No	Leboo Healthcare Products Limited- China	Vinatoken Trading and Technology Company Limited - Vietnam	Dust-proof, Antibacterial, Chemical-resistant - Used in Factories, Workshops, Laboratories, Hospitals, Construction Sites, Daily Life,...	4	Medical Equipment Type A
5	SMS Fabric Surgical Gown	No	Leboo Healthcare Products Limited- China	Vinatoken Trading and Technology Company Limited - Vietnam	Preventing the Spread of Bacteria from Healthcare Workers to the Surgical Site and Vice Versa in Surgical Cases	4	Medical Equipment Type A
6	PP Fabric Surgical Gown	No	Leboo Healthcare Products Limited- China	Vinatoken Trading and Technology Company Limited - Vietnam	Preventing the Spread of Bacteria from Healthcare Workers to the Surgical Site and Vice Versa in Surgical Cases	4	Medical Equipment Type A
7	Powdered Latex Examination Gloves	No	Leboo Healthcare Products Limited- China	Vinatoken Trading and Technology Company Limited - Vietnam	Specialized in the fields of healthcare, food, laboratories, and some light industries.	4	Medical Equipment Type A
8	Latex examination gloves, powder-free	No	Leboo Healthcare Products Limited- China	Vinatoken Trading and Technology Company Limited - Vietnam	Specialized in the fields of healthcare, food, laboratories, and some light industries.	4	Medical Equipment Type A
9	Nitrile gloves	No	Leboo Healthcare Products Limited- China	Vinatoken Trading and Technology Company Limited - Vietnam	Specialized in the fields of healthcare, food, laboratories, and some light industries.	4	Medical Equipment Type A
10	medical foot cover	No	Leboo Healthcare Products Limited- China	Vinatoken Trading and Technology Company Limited - Vietnam	Using the elastic band of the socks to hug the ankles tightly.	4	Medical Equipment Type A

7. Organizations Conducting Medical Device Classification

The classification of medical devices must be conducted by an organization that meets the conditions specified in Article 7 of Decree 36/2016/NĐ-CP dated May 15, 2016, of the Government on the management of medical devices, as amended and supplemented in Clause 3, Article 1, Decree 169/2018/NĐ-CP dated December 31, 2018.

The organization conducting the classification of medical devices is responsible before the law for the classification results of the medical devices it has classified.

In case of disagreement on the classification results of medical devices, the Ministry of Health will decide on the classification of medical devices.

8. Conditions for Organizations Conducting Medical Device Classification

Conditions for organizations conducting medical device classification:

Legally established in accordance with the law;
Have personnel conducting medical device classification meeting the conditions specified in Clause 2 of this Article.

Conditions for personnel conducting medical device classification:

Have a university degree in engineering or medicine and pharmacy or higher;
Have at least 24 months of direct work experience in medical equipment technology at hospitals, medical examination and treatment facilities with beds, medical equipment training institutions, medical equipment research institutions, medical equipment manufacturing facilities, organizations conducting medical device classification, medical device management agencies (hereinafter referred to as medical device facilities);
Have been tested and certified by the training institution as capable of classifying medical devices according to the training program issued by the Ministry of Health.

Organizations are only allowed to classify medical devices after being granted a certificate of receipt of a dossier declaring eligibility to classify medical devices by the Ministry of Health as prescribed in point b, Clause 1, Article 9 of this Decree.

9. Documentation for Classification of Medical Devices

According to Article 5 of Decree No. 169/2018/NĐ-CP, which specifies the required documents for the classification of medical devices:

9.1. Article 5. Entities responsible for the classification of medical devices

Entities performing the classification must base themselves on the definitions provided in Article 2 of this Decree, the principles provided in Article 4 of this Decree, the documents specified in points e, g, h, and i of Clause 1, Article 26 of this Decree, and the classification rules issued by the Ministry of Health to carry out the classification of medical devices.

9.2. Article 26. Application for a new circulation number

1. Application for a new circulation number for medical devices without corresponding national technical regulations:

e) A free circulation certificate valid at the time of application submission for imported medical devices;

g) A technical summary of the medical device in Vietnamese following Form No. 01 specified in Appendix VIII issued together with this Decree, accompanied by technical documentation describing the functions and technical specifications of the medical device issued by the medical device owner;

Specifically for in vitro test kits, calibrators, and controls: Technical documentation in Vietnamese following Form No. 02 specified in Appendix VIII issued together with this Decree, accompanied by documentation on raw materials, product safety, manufacturing process, clinical and preclinical research reports, including stability reports;

h) A common technical dossier following the guidelines of the ASEAN Agreement on Medical Devices;

i) Instructions for use of the medical device;

10. Medical Device Classification Procedure

Previously, there were regulations recognizing the classification results of medical devices. However, according to Decree 169/2018/ND-CP (amending Decree 36/2016/ND-CP), all medical devices imported into Vietnam must be classified by qualified units in Vietnam without further recognizing the classification results following these steps:

Step 1: The client prepares a complete soft copy of the application package following the instructions (only photocopies with the client's company stamp are required).

Step 2: Send the soft copy of the application to Thien Di via the email address on the website. Thien Di will respond with the expected classification result and payment information. After the client makes the payment, Thien Di will check and complete the soft copy of the application and send it to the client.

Step 3: The client sends the hard copy of the application to Thien Di's address on the website for classification. Clearly state the information and address of the recipient of the results to send the results after the classification is completed.

11. Processing Time for Importing Medical Equipment:

2-5 working days, depending on the specific application.

After receiving the classification results, clients can proceed with the necessary procedures to import medical equipment, such as applying for an import license, declaring applicable standards, or registering for circulation. If clients have any questions about the import procedures for medical equipment, they can contact us for advice on the sequence, procedures, and necessary documents required for the import.

12. Recognition of Medical Equipment Classification Results:

Medical equipment does not need to be re-classified in Vietnam if it has already been classified by a competent authority of a country that Vietnam recognizes based on international treaties or agreements to which the Socialist Republic of Vietnam is a member, or a country that applies a medical equipment classification system similar to Vietnam's.

The Minister of Health shall publish a list of countries whose medical equipment classification results are recognized by Vietnam.

13. Looking Up Medical Equipment Prices:

The newly launched Medical Transparency Portal athttps://congkhaiyte.moh.gov.vn serves as the official channel of the Ministry of Health for individuals and businesses to look up information on drug prices, medical equipment and supplies prices, diagnostic kit prices, and medical examination and treatment prices.

14. Medical Device Classification Services by Thien Di

Thien Di provides a range of services related to the classification of medical devices in Vietnam, including:

Consulting on regulations, documentation, and procedures: We offer guidance on the current laws and regulations governing medical device classification permits.
Instructing clients on the application process: We provide step-by-step instructions on how to complete the application for a medical device classification permit.
Drafting and submitting documents: We can assist in drafting and submitting all necessary documents to the relevant government agencies on behalf of our clients.
Monitoring and receiving results: We monitor the application process and follow up with the government agencies until the final results are delivered to our clients.

15. 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.

15.1. 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.