Requirements for production of medical equipment in Vietnam

Requirements for production of medical equipment in Vietnam

Requirements for production of medical equipment and requirements for declaration of eligibility to produce medical equipment in Vietnam is governed by Decree No. 36/2016/ND-CP dated 15th May, 2015 and 169/2018/ND-CP dated 31st December, 2018  of Vietnamese Government on on medical equipment management (Hereinafter called Decree 36/2016/ND-CP)

Medical equipment includes equipment, tools, materials for implanting activities, reagents and in vitro calibration solutions, software which satisfies all following requirements:
a) are used separately or in association with each other according to the instruction of their owners for human use for one or more of the following purposes:
- To diagnose, prevent, supervise, treat and eliminate the illness or to make up for pains;
- To examine, replace, adjust or assist surgery activities or physiology processes;
- To support or sustain life;
- To control the conception;
- To sterilize medical equipment, including chemicals used in testing;
- To serve the specialized transport or use for healthcare activities;
- Provide information serving the diagnosis, supervision and treatment through the examination of samples taken from human body.
b) Do not use pharmacological, immunological or metabolic mechanisms in or on the human body or, if used, are only supportive to achieve the purposes specified at point a of this clause.

Investment for the production of medical equipment shall be subject to reduction or exemption from rents for State owned land and shall be eligible for other investment incentives as prescribed by laws on investment and science and technology.

I. Requirements for employees of producers of medical equipment in Vietnam.
1. The professionals must:
a) Having a college degree in medical equipment engineering or higher or a university degree in engineering or medicine or pharmacy or higher. For establishments manufacturing medical equipment containing narcotic substances and precursors, the person in charge of expertise must have a university degree in medical equipment, medicine, pharmacy, chemistry or biology;
b) Have at least 24 months experience of working in the field of technique of medical equipment at a medical equipment-providing facility for at least 24 months;
c) Be a full-time worker at the producer’s factory. The assignment and appointment of professionals of producer shall be made in writing.
2. Other employees of producer must satisfy requirements for producing medical equipment manufactured.

II. Requirements for quality control of producers of medical equipment in Vietnam

1. Meet the standards of ISO 9001 quality management system and ISO 13485 quality management system.
2. For establishments manufacturing medical equipment containing narcotic substances and precursors, in addition to satisfying the conditions specified in Clause 1 of this Article, there must be a system to monitor and manage the import and export process. inventory, use of raw materials being narcotic substances and precursors, the process of export and import, inventory of medical equipment containing narcotic substances and precursors, and storage warehouses meeting the provisions of Article 7 of Decree No. 80/2001/ND-CP dated November 5, 2001 of the Government guiding the control of lawful drug-related activities in the country (hereinafter referred to as Decree 80/2001/ND-CP for short).

III. Declaration of eligibility to produce medical equipment in Vietnam.

A declaration of eligibility to produce medical equipment shall consist of the following documents:

1. A declaration of eligibility to produce medical equipment using the form No. 02 specified in Annex I enclosed with Decree 36/2016/ND-CP.
2. A list of employees using the form specified in Annex II enclosed with Decree 36/2016/ND-CP.
3. A document on assignment/appointment of professionals of the producing establishment, enclosed with the certificates of working time using the form in Annex III enclosed with Decree 36/2016/ND-CP and qualifications of the professionals.
4. Certificate of meeting quality management standards recognized by conformity assessment organizations as prescribed by law.
In case the establishment fails to conduct the product quality inspection itself, or in case the establishment does not have storage facilities or transport vehicle and sign a contract with another establishment for quality inspection, storage and transport, documents proving that such contracting establishment is capable of conducting quality inspection, storing and transporting medical equipment produced by the producing establishment must be enclosed.
5. Papers evidencing satisfaction of the conditions specified in Clause 2, Section II above.

IV. Requirements for declaration of eligibility to produce medical equipment in Vietnam

1. The declaration of eligibility to produce medical equipment shall be made in 1 set, where:
a) Documents  shall be readable and arranged according to the order provided for in Clause III; there shall be separators between different parts, there shall be cover pages and the table of contents;
b) Documents must be made in either English or Vietnamese.

2. Requirements for documents in the declaration of eligibility to produce medical equipment:
a) An original copy or a certified true copy of the written assignment/appointment or qualifications of professionals of the producing establishment;
b) The original copies or the certified true copies of documents proving that the establishment satisfying requirements specified in clauses 1, 2, 3 and 4 Clause II;
c) An original copy or a certified true copy or a copy certified by the applicant establishment of the Certificate of conformity with quality control standards.

V. Procedures for making declaration of eligibility to produce medical equipment in Vietnam

1. The establishment shall carry out the production of medical equipment only when it has obtained the receipt note prescribed in point b clause 2 of this Article.

2. Procedures for making declaration of eligibility to produce medical equipment:
a) Before producing medical equipment, heads of medical equipment producing establishments shall send a declaration of eligibility to produce medical equipment specified in Clause III to the Department of Health of the locality where the producing factory is headquartered;
b) If the declaration is satisfactory, the Department of Health shall issue the establishment with the receipt note using the form No. 02 in Annex IV enclosed with Decree 36/2016/ND-CP; In case the establishment declares the production of medical equipment containing narcotics and precursors, the Department of Health is responsible for sending a copy of the receipt for the declaration of eligibility for production to the Ministry of Public Security.
c) Within 03 working days from the date written on the receipt note, the Department of Health shall publish the following information on its web portal: name of the establishment; the professionals in charge; medical equipment produced by the establishment; contact address and phone number and the declaration of eligibility to produce medical equipment, except for the producing procedures and the quality inspection procedures.

3. During its operation, if there is any change related to the accepted declaration, the producing establishment shall re-conduct the procedures for declaration of eligibility to produce medical equipment.

4. If the producing establishment has its producing site relocated to another province, is must notify the Department of Health where it has made the declaration of eligibility to produce medical equipment within 10 working days from the date of relocation.
Within 03 working days from the day on which the notification of the relocation of producing site is received, the Department of Health receiving the declaration of eligibility to produce medical equipment shall terminate the publication of information relevant to such establishment.

Any information about requirements for production of medical equipment in Vietnam, feel free to contact us.

Lawyer Vietnam Law Firm- Vietnamese Lawyers