What are regulations on procedures for providing consultancy services on medical devices technology in Vietnam?
Hello Lawnet. My name is Tuan Sang. I'm a new medical device staff. While I am being guided on the practical experience of managing medical equipment, there is an issue that I am not quite clear about. What are procedures for providing consultancy services on medical devices technology in Vietnam? Thank you!
What are procedures for providing consultancy services on medical devices technology in Vietnam? - image from internet
Pursuant to Section 1, Chapter VI of the Decree 36/2016/ND-CP on medical devices management (amended by Clauses 23 and 24, Article 1 of the Decree 169/2018/ND-CP) stipulating procedures for providing consultancy services on medical devices technology in Vietnam:
- Conditions for providing consultancy services on medical devices technology:
1. The provision of services for consulting about the listing and formulation of technical structure and specifications of medical devices technology shall be conducted by an individual who has been issued with the certificate of completing the training in consulting medical devices technology.
2. Requirements applicable to individuals providing consultancy services on medical devices technology:
a) Having university level qualifications specified in technique or medicine/pharmacy;
b) Having at least 5 years’ experience of working in the field of medical devices technology at a medical devices-providing facility;
c) Having been tested and recognized by training institutions to be capable of consulting on medical devices technology according to the training program issued by the Ministry of Health.
3. The consultant shall provide only consultancy on medical devices technology when he/she has obtained the certification of declaration for the application for declaration of eligibility to provide consultancy about medical devices technology as prescribed in point b clause 2 Article 48 of this Decree.
Application and procedures for declaration of eligibility to provide consultancy on medical devices technology
1. An application for declaration of eligibility to provide consultancy on medical devices technology shall include:
a) An application form for declaration of eligibility to provide consultancy using the form No. 09 specified in Annex I enclosed with this Decree;
b) Certified true copies of qualifications specified in points a and c clause 2 Article 47 of this Decree;
c) A certificate of working time using the form in Annex II enclosed with this Decree.
2. Procedures for declaration of eligibility to provide consultancy on medical devices technology:
a) Before providing consultancy on medical devices technology, the applicant shall send the documents specified in clause 1 of this Article to the Ministry of Health;
b) If the application is satisfactory, the Ministry of Health shall issue the certification of declaration using the form No. 07 provided in Annex IV enclosed with this Decree;
c) Within 03 working days from the date written on the certification of declaration, the Ministry of Health shall publish the following information on its web portal: name, address, phone number of the consultant; scope of consultancy on medical devices technology and the declaration of eligibility to provide consultancy on medical devices technology.
3. During its operation, if there is any change related to the accepted declaration, the consultant shall re-conduct the procedures for declaration of eligibility to provide consultancy on medical devices technology.
Best regards!
