GUIDE TO APPLYING FOR A CERTIFICATE OF SATISFYING CONDITIONS FOR MANUFACTURING MEDICAL DEVICES

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Procedure for obtaining a medical device manufacturing license in Vietnam

With the advancement of medical technology, there has been a significant increase in the number of medical devices available to meet the healthcare needs of the population. In Vietnam, any entity that wishes to manufacture medical devices must first obtain a manufacturing license. This license ensures that the manufacturing facility meets the requirements set forth by the Law on Medical Devices and other relevant regulations.

1. Legal Framework:

The following regulations govern the process of obtaining a medical device manufacturing license in Vietnam:

Law on Enterprises 2015
Decree 36/2016/NĐ-CP
Decree 169/2018/NĐ-CP

2. What are Medical Devices?

Medical devices (MDs) are any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for a medical purpose.

Purposes of Medical Devices:

Diagnosis, prevention, monitoring, treatment, and alleviation of disease or injury.
Examination, replacement, adjustment, or support of anatomy and physiological processes.
Support or sustain life.
Control of fertility.
Disinfection of MDs, including chemicals used in testing procedures.
Providing information for diagnosis, monitoring, and treatment by testing samples of human origin.

Exclusions:

Devices that do not use pharmacological, immunological, or metabolic mechanisms in or on the human body, or if they do, only as an auxiliary to achieve the intended purposes.

In Vitro Diagnostic Medical Devices (IVDMDs):

IVDMDs include reagents, calibrators, controls, instruments, apparatus, equipment, or systems used alone or in combination, as intended by the manufacturer, for the examination of samples of human origin.

3. Requirements for medical device manufacturing facilities

In addition to having business lines with codes related to medical device manufacturing, medical device manufacturing facilities must also meet the following conditions:

3.1. Personnel Requirements

(Article 12 of Decree 36/2016/NĐ-CP, amending and supplementing some articles of Decree 169/2018/NĐ-CP)

A medical device manufacturing facility must have at least one person in charge of medical devices, who must meet the following conditions:

Have a technical college degree in medical devices or a university degree in engineering, medicine, or pharmacy. For manufacturing facilities of medical devices containing narcotics and precursors, the person in charge must have a university degree in medical devices, medicine, pharmacy, chemistry, or biology.
Have at least 24 months of direct experience in medical device engineering at medical device facilities.
Work full-time at the manufacturing facility. The assignment and appointment of the person in charge of the manufacturing facility must be in writing.

3.2. Requirements for infrastructure, equipment, and quality management of medical device manufacturing facilities

(Article 13 of Decree 36/2016/NĐ-CP, amending and supplementing some articles of Decree 169/2018/NĐ-CP)

Meet the quality management system standards specified in Clause 1, Article 68 of this Decree (Specifically, the manufacturing facility must apply the quality management system: ISO 9001 quality management system and ISO 13485 quality management system)
For manufacturing facilities of medical devices containing narcotics and precursors, in addition to meeting the above conditions, there must be a system for monitoring and managing the process of exporting, importing, inventorying, and using raw materials that are narcotics and precursors, the process of exporting, importing, inventorying medical devices containing narcotics and precursors, and a warehouse that meets the regulations in Article 7 of Decree No. 80/2001/NĐ-CP dated November 5, 2001 of the Government guiding the control of legal activities related to drugs domestically (hereinafter referred to as Decree 80/2001/NĐ-CP).

4. Documents Required for a Medical Device Manufacturing License in Vietnam

The application package for a medical device manufacturing license in Vietnam must include the following documents:

Declaration of Compliance with Manufacturing Conditions
Personnel List
Appointment Letter of the Technical Manager
Quality Management Certificate

Note: If the applicant does not have its own quality control facilities, warehouse, or transportation means, and contracts with another entity for these services, the application must also include documents proving that the contracted entity meets the requirements for quality control, storage, and transportation of the medical devices to be manufactured.

Requirements for the Application Package:

All documents must be clearly printed and arranged in order.
Any documents not in English must be translated into Vietnamese.
Original or certified copies of the following documents must be submitted:
- Appointment letter of the technical manager.
- Diplomas and certificates of the technical manager.
Original or certified copies, or copies certified by the applicant, of the Quality Management Certificate.

5. Procedure for Applying for a Medical Device Manufacturing License in Vietnam

Step 1: Before starting production, the head of the medical device manufacturing facility must submit a declaration of eligibility for production to the Department of Health where the factory or plant is located.

Step 2: Upon receiving a complete and valid application, the Department of Health will issue a Receipt of Application for Declaration of Eligibility for Production of Medical Devices (Form No. 02) to the facility. This form is specified in Appendix IV of Decree No. 36/2016/NĐ-CP.

Step 3: Within 3 working days from the date on the Receipt of Application, the Department of Health must publicly disclose the following information on its electronic portal:

Name of the manufacturing facility
Name of the technical manager of the manufacturing facility
Medical devices manufactured by the facility
Address and contact number
Declaration of eligibility for production, excluding the manufacturing process and quality control process

Applications must be submitted online through the medical device management portal.

6. Adjustments and Re-application for Declaration of Eligibility for Production:

During operation, the manufacturing facility must re-apply for the manufacturing license if there are any changes related to the previously declared information.
If the manufacturing facility changes its production location from one province to another, it must notify the Department of Health where it previously declared eligibility for production within 10 working days from the date of the location change.
Within 3 working days from receiving the notification of the change in production location, the Department of Health that received the original declaration of eligibility for production must cease publishing all information related to the facility.

7. Documents Required from the Client:

Certificate of Enterprise Registration with the business line of manufacturing medical devices.
Document assigning and appointing a professional in charge of the manufacturing facility, accompanied by a confirmation of the working time of the professional in charge according to the template and the diplomas and certificates of training of the professional in charge.
Notarized copy of the certificate of meeting quality management standards recognized by a conformity assessment organization as prescribed by law.
Documents proving the transportation capacity of the company.
Documents proving the warehouse conditions and facilities for manufacturing medical devices.

8. Our Services:

Provide consultation on procedures and legal issues related to the application for a medical device manufacturing license.
Collect documents from the client.
Prepare a complete and comprehensive application dossier.
Submit the application dossier to the competent authority.
Accompany the client during the dossier appraisal and the on-site inspection at the facility.
Receive the results and hand over the original to the client.

9. 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.

9.1. 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.