THIEN DI PROVIDES MEDICAL EQUIPMENT STANDARD DECLARATION SERVICES

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Decree 36/2016/ND-CP on the Management of Medical Equipment, which took effect on July 1, 2016, introduced new regulations on the management of medical equipment.

According to the decree, depending on the scope of business, enterprises trading in medical equipment must carry out the following procedures:

Declare the applied standards for Class A medical equipment.
Register for circulation for Class B, C, and D medical equipment.
Apply for import licenses in other cases.

Enterprises must classify the medical equipment they trade, and the classification must be conducted by an organization qualified and approved by the Ministry of Health.

Before classifying medical equipment, the organization performing the classification must submit a dossier declaring the eligibility to classify medical equipment according to the regulations of the Ministry of Health.

1. What is medical equipment?

Medical equipment is defined in Clause 1, Article 2 of Decree 36/2016/NĐ-CP on the management of medical equipment as follows:

Medical equipment is any type of equipment, instrument, material, implantable material, in vitro test reagent and calibrator, software, used alone or in combination as directed by the owner of the medical equipment to serve humans for one or more of the following purposes:

a) Diagnose, prevent, monitor, treat, and alleviate disease or compensate for injury or trauma;

b) Test, replace, adjust, or assist in surgery and physiological processes;

c) Support or sustain life;

d) Control conception;

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

f) Specialize in transportation or use for medical activities;

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

2. Conditions for Declaration of Medical Equipment Standards

According to Chapter IV of Decree 36/2016/ND-CP on the circulation of medical equipment, the procedure for declaring applied standards will be applied to Class A medical equipment.

Therefore, the conditions for declaring applied standards for Class A medical equipment are as follows:

The enterprise must meet the following conditions before it can proceed with the declaration of applied standards for medical equipment:

The organization entitled to declare the applied standard for medical equipment includes:

Enterprises, cooperatives, and business households in Vietnam that are the owners of medical equipment;
Enterprises, cooperatives, and business households in Vietnam that are authorized by the owner of medical equipment to register for the business of medical equipment;
Representative offices in Vietnam of foreign traders where the trader is the owner of the medical equipment or is authorized by the owner of the medical equipment.

a) Manufactured at a production facility that has declared sufficient conditions for production for domestically produced medical equipment;

b) Manufactured at a production facility that has been granted a Certificate of Compliance with Quality Management Standards and is circulated in any country in the world for imported medical equipment;

c) Comply with national technical regulations or standards declared applicable by the manufacturer.

In addition to the above conditions, the following requirements on warranty conditions must be met for medical equipment with warranty:

The organization entitled to declare the applied standard must have a warranty facility in Vietnam or must have a contract with an organization that is qualified to maintain the medical equipment for which it is registered.
In case the organization entitled to declare is a foreign trader with a representative office in Vietnam, it is necessary to have a contract with an organization that is qualified to maintain the medical equipment for which it is registered, except for cases of medical equipment. single use according to the regulations of the owner of the medical equipment.
The warranty facility must be certified by the owner of the medical equipment as having the capacity to maintain the product for which the organization requests a circulation number.

3. Procedures for Declaring Medical Equipment Standards

Step 1: Before circulating medical equipment on the market, the entity responsible for bringing the equipment to market must submit a file declaring the applicable standards according to regulations to the Department of Health where the entity is headquartered.

Step 2: Upon receiving a complete and valid application, the Department of Health shall issue to the entity implementing the declaration a Receipt of Application for Declaration of Applicable Standards form No. 03 as prescribed in Appendix IV of Decree No. 36/2016/ND-CP.

Step 3: Within 03 working days from the date on the Receipt of Application, the Department of Health is responsible for publicly disclosing the following information on its electronic portal:

Name, classification, manufacturer, and country of origin of the medical equipment;
Circulation number of the medical equipment;
Name and address of the owner of the medical equipment;
Name and address of the owner of the circulation number;
Name and address of the entity responsible for the warranty of the medical equipment;
Application file for declaring the applicable standards for the medical equipment.

4. Submission Methods:

By mail
In person at the administrative agency's office
Online

5. Required Documents for Declaring Medical Device Standards:

5.1. Contents:

- Declaration of Applied Standards for Class A Medical Devices (Form No. 03, Appendix I, Decree 169/2018/NĐ-CP)

- Medical Device Classification Form (Appendix V, Decree 169/2018/NĐ-CP)

- Valid Quality Management Certificate at the time of submission

For domestically produced medical devices, an additional "Acceptance Receipt for Declaration of Eligibility to Produce Medical Devices" is required.

Power of Attorney from the medical device owner to the organization declaring the applied standards (Form No. 06, Appendix VI, Decree 169/2018/NĐ-CP) valid at the time of submission, except for Vietnamese enterprises, cooperatives, and business households that own the medical device.
Certificate of Warranty Eligibility issued by the medical device owner (Form No. 07, Appendix VII, Decree 36/2016/NĐ-CP), except for single-use medical devices as specified by the owner or with documentation proving no warranty exists.
Technical Summary of the Medical Device in Vietnamese (Form No. 01, Appendix VIII, Decree 36/2016/NĐ-CP) accompanied by technical documentation describing the functions and specifications of the medical device issued by the owner.

For in vitro test kits, calibrators, and controls:

Technical documentation in Vietnamese (Form No. 02, Appendix VIII, Decree 169/2018/NĐ-CP)
Documentation on raw materials, product safety, production process, clinical and preclinical research reports including stability reports

- Certificate of Conformity or Product Standard declared by the medical device owner, accompanied by the results of the evaluation of physical, chemical, microbiological and other parameters issued by a qualified institution according to the regulations on conformity assessment for domestically produced medical devices. The evaluation results must comply with the standards declared by the owner.

- Instructions for Use of the Medical Device

- Label Sample to be used for circulation in Vietnam of the medical device

- Valid Free Circulation Certificate at the time of submission for imported medical devices.

Requirements for Certain Documents in the Declaration of Applied Standards Dossier:

a) For the Receipt Slip for the Declaration of Eligibility for Production: Submit a certified copy by the organization declaring the applicable standard.

b) For the Quality Management Certificate:

Submit the original, a certified copy, or a copy certified by the organization declaring the applicable standard;
If the Quality Management Certificate is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to legal regulations.

c) For the Authorization Letter from the Medical Device Owner and the Certificate of Facility Eligibility for Warranty:

For domestically manufactured medical devices: Submit the original or a certified copy;
For imported medical devices: Submit a consular legalized copy or a certified copy of the consular legalized copy.

d) For the Certificate of Conformity or the Standard that the Medical Device Owner Declares to Apply:

Submit a certified copy by the organization declaring the applicable standard.
If the Standard is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to legal regulations;

e) For the Medical Device User Manual: Submit a Vietnamese version certified by the organization declaring the applicable standard;

f) For the Label Sample: Submit a sample of the label certified by the organization declaring the applicable standard. The label sample must meet the requirements specified in Article 54 of Decree 36/2016/ND-CP.

g) For the Free Circulation Certificate:

Submit a consular legalized copy or a certified copy of the consular legalized copy.
If the Free Circulation Certificate is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to legal regulations.
If the Free Circulation Certificate does not specify an expiration date, the expiration date of the Free Circulation Certificate will be calculated as 36 months from the date of issuance.

5.2. Number of Application Sets: 01 (set)

6. Processing Time for Medical Equipment Standard Disclosure Procedures:

Issuance of Application Receipt Slip: Immediately after submitting a complete and valid application.
Public announcement on the electronic portal: 03 working days from the date of application receipt.

7. Fee for Medical Equipment Standard Disclosure Procedures:

Fee for Medical Equipment Standard Disclosure Procedures: 1,000,000 VND (approximately $43 USD) to be sent to the account of the local Department of Health where the enterprise's head office is located.

8. Exemptions from Declaration of Applied Standards and Circulation Registration for Medical Equipment

Based on Decree 36/2016/ND-CP on the management of medical equipment and Decree 169/2018/ND-CP amending Decree 36/2016/ND-CP on the management of medical equipment, the following medical equipment are exempt from declaring applied standards and registering for circulation:

Medical equipment used solely for research, testing, user instruction, and repair of medical equipment.
Medical equipment imported into Vietnam for aid purposes or for use at fairs, exhibitions, product demonstrations, or as gifts.
Medical equipment manufactured in Vietnam solely for export or for display at fairs and exhibitions abroad.

9. Thien Di's Services for Medical Equipment Standard Declaration Procedures

Consulting on conditions for medical equipment standard declaration;
Consulting on file preparation and information to complete the declaration file;
Drafting related documents;
Representing enterprises in carrying out medical equipment standard declaration procedures at competent state agencies;
Communicating and providing information to customers during the declaration process.

10. 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.

10.1. 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.