Latest registration documents for circulation of medical equipment

Medical equipment is a special type of goods used in medicine and has a direct impact on human health and life. Therefore, the Government has issued decrees and circulars related to registration of circulation of medical equipment for the purpose of managing the quality of medical equipment and ensuring medical examination and treatment for people. Let’s find out with Medgate what documents a medical device registration application includes and the requirements for each document.

What is registration for circulation of medical equipment and cases of exemption from registration for circulation of medical equipment

Registration for circulation of medical equipment is a procedure prescribed by regulatory agencies for individuals, businesses and organizations that own and use medical equipment. According to regulations, businesses are required to carry out the medical device registration process. Specific regulations are clearly stated in the instructions for Decree 98/2021/ND-CP issued in 2021, Circular 19/2021/TT-BYT issued in 2021, Circular 278/2016/TT-BTC issued in 2021. 2016.

So when will medical equipment be exempted from declaring applicable standards and exempting from registration for circulation?

Article 24 of Decree 98/2021 clearly states the cases where medical equipment is exempted from declaring applicable standards and exempting from registration for circulation, specifically as follows:

• Medical equipment is only used for research, testing, inspection, quality control, testing, quality assessment, instructions on the use of medical equipment, and equipment repair. medical.
• Medical equipment is imported into the Vietnamese market for humanitarian aid or medical examination and treatment, or to serve exhibitions, fairs, displays, or product introductions or for advertising and marketing purposes. gifts for medical examination and treatment facilities, personal characteristics or special diagnostic needs of the medical facility.
• Medical equipment that does not have a circulation number is imported to meet the urgent needs of disease prevention and overcoming the consequences of natural disasters, but the market currently does not have medical equipment available to serve that need.
• Medical equipment produced in Vietnam is only intended for export or participation in fairs, displays, and exhibitions abroad.

What documents are included in the registration dossier for circulation of medical equipment?

According to Article 30 of Decree 98/2021/ND-CP, dossiers requesting new circulation numbers for medical equipment for specific cases are presented as follows:

Dossier requesting issuance of registration number for circulation of new medical equipment in case the medical equipment has corresponding national technical regulations.

• Application for new circulation number for medical equipment.
• Certificate of ISO 13845 standard (quality management standard). This certificate is required to be valid at the time of submitting this application.
• The power of attorney from the owner of the medical equipment to the establishment registering for circulation is still valid at the time of submitting the application, unless a Vietnamese enterprise, cooperative, or business household is the owner. own that medical equipment.
• Certificate of warranty eligibility issued by the owner of the medical equipment, except in cases where the medical equipment does not have a warranty (with supporting documents) or where the medical equipment is used only once. times according to the owner’s regulations.
• The medical equipment circulation certificate is still valid at the time of application submission for imported medical equipment.
• General technical dossier for medical equipment according to ASEAN regulations (CSDT).
• Certificate of compliance with medical equipment regulations.

Dossier requesting issuance of registration number for circulation of medical equipment (new issuance dossier) for medical equipment that is a measuring device must have sample approval according to legal regulations on measurement:

• Application for issuance of circulation number for medical equipment.
• Paper approval decision for sample.
• Certificate of ISO 13845 standard (quality management standard). This certificate is required to be valid at the time of submitting this application.
• The power of attorney from the owner of the medical equipment to the establishment registering for circulation is still valid at the time of submitting the application, unless a Vietnamese enterprise, cooperative, or business household is the owner. own that medical equipment.
• Certificate of warranty eligibility issued by the owner of the medical equipment, except in cases where the medical equipment does not have a warranty (with supporting documents) or where the medical equipment is used only once. times according to the owner’s regulations.
• Medical equipment circulation certificate is still valid at the time of application submission for imported medical equipment.
• Technical documents for medical equipment according to ASEAN regulations (CSDT).

Dossier to apply for a license to circulate medical equipment for medical equipment in the case of expedited issuance specified in Clause 2, Article 29 of Circular 98/2021/TT-BYT:

• Application for new issuance of registration number for circulation of medical equipment.
• Certificate of ISO 13845 standard (quality management standard). This certificate is required to be valid at the time of submitting this application.
• The power of attorney from the owner of the medical equipment to the establishment registering for circulation is still valid at the time of submitting the application, unless a Vietnamese enterprise, cooperative, or business household is the owner. own that medical equipment.
• Certificate of warranty eligibility issued by the owner of the medical equipment, except in cases where the medical equipment does not have a warranty (with supporting documents) or where the medical equipment is used only once. times according to the owner’s regulations.
• The circulation permit is still valid at the time of application submission for imported medical equipment.
• In case of imported medical equipment, request to provide circulation certificate or emergency use license.
• Technology transfer contract in the case of domestically produced medical equipment in the form of technology transfer for medical equipment falling into one of the cases in clauses a, b, c, d, clause 3, article 29. Circular 98/2021/TT-BYT.
• Processing contract for domestically produced medical equipment with the form of processing in the cases in clauses a, b, c, d, clause 3, article 29 of Circular 98/2021/TT-BYT.
• Certificate of inspection or quality assessment of medical equipment belonging to the units on the list published on the website of the Ministry of Health, in the following cases: domestic production; authorized for circulation and emergency use by regulatory agencies in the EU, UK, and Switzerland but is not on the list of popular products announced by the EUHSC.
• Technical profile of CSDT.

Application dossier for new circulation registration for other medical equipment:

• Application for new issuance of registration number for circulation of medical equipment.
• Certificate of ISO 13845 standard (quality management standard). This certificate is required to be valid at the time of submitting this application.
• The power of attorney from the owner of the medical equipment to the establishment registering for circulation is still valid at the time of submitting the application, unless a Vietnamese enterprise, cooperative, or business household is the owner. own that medical equipment.
• Certificate of warranty eligibility issued by the owner of the medical equipment, except in cases where the medical equipment does not have a warranty (with supporting documents) or where the medical equipment is used only once. times according to the owner’s regulations.
• The circulation permit is still valid at the time of application submission for imported medical equipment.
• Evaluation results for dossiers designated by the Ministry of Health unit and general technical dossiers on medical equipment according to ASEAN regulations (CSDT).
•  In the case of in vitro diagnostic medical equipment being reagents, calibrators, and control materials, a quality certificate issued by a competent Vietnamese agency is required.
• For chemicals and products that only have the purpose of disinfection, additional testing certificates and the content of active disinfectant substances have been required from the unit that is qualified to perform the testing; The test form evaluates the effectiveness and side effects of the product for test participants of qualified units.

Thus, for each specific case, registration for circulation of medical equipment requires specialized documents. To receive free consultation on medical equipment registration services and registration issues, contact Medgate via Hotline: 098.546.1894  or send to Email: medgatevn@gmail.com for Medgate to receive advice. question.