REGISTRATION FOR CIRCULATION APPLICABLE TO
MEDICAL DEVICES CLASS C, D

Medical devices intended for circulation in the market must undergo classification and then registration for circulation, applicable to medical devices of Class C, D.

The registration process for the circulation of Class C, D medical devices is complex and time-consuming in terms of preparing documentation and procedures with governmental authorities. Therefore, inexperienced entities may easily encounter situations where their documents are repeatedly returned for supplements or clarification of document-related issues, affecting the business plans of the entity.

Understanding the concerns and anxieties of clients, Medgate provides registration services for the circulation of Class C, D medical devices at reasonable costs and with time-saving.

Legal Basis and Conditions for Registering Circulation Applicable to Class C, D Medical Devices and Cases exempted from registering the circulation of medical devices

 Legal Basis

– Decree 98/2021/ND-CP issued on November 8, 2021: On the management of medical devices

– Circular 10/2023/TT-BYT issued on May 11, 2023: Amending and supplementing certain provisions of Circular 19/2021/TT-BYT dated November 16, 2021, by the Minister of Health, stipulating the templates for documents and reports implementing Decree 98/2021/ND-CP dated November 8, 2021, by the Government on the management of medical devices.

– Circular 19/2021/TT-BYT dated November 16, 2021: Regulating templates for documents and reports implementing Decree 98/2021/ND-CP dated November 8, 2021, by the Government on the management of medical devices.

– Decree 07/2023/ND-CP issued on March 3, 2023: Amending and supplementing certain provisions of Decree 98/2021/ND-CP dated November 8, 2021, by the Government on the management of medical devices.

– Circular 05/2022/TT-BYT issued on August 1, 2022: Detailed regulations for implementing certain provisions of Decree 98/2021/ND-CP dated November 8, 2021, by the Government on the management of medical devices.

Conditions for Registering Circulation Applicable to Type C, D Medical Devices (According to Clause 1, Article 23 of Decree 98/2021/ND-CP on the management of medical devices)

a) Produced at a facility that has declared sufficient conditions for production of domestic medical devices;

b) Manufactured at a facility that has been granted ISO 13485 certification and is circulated in any country worldwide for imported medical devices;

c) Compliant with national technical standards or standards declared by the manufacturer.

Cases exempted from registering the circulation of medical devices (According to Article 24 of Decree 98/2021/ND-CP on the management of medical devices)

a) Medical devices intended solely for research, experimentation, testing, inspection, examination, quality evaluation, user training, repair of medical devices.

b) Imported medical devices into Vietnam for humanitarian aid, or to examine, treat patients on a humanitarian basis, or to serve activities such as fairs, exhibitions, displays, product introductions, or as gifts for medical facilities, or for personal diagnosis or specific diagnostic needs of medical facilities.

c) Medical devices without circulation numbers imported to meet urgent epidemic prevention and control, disaster relief, for which there are no alternative medical devices available on the market.

d) Medical devices manufactured in Vietnam solely for export or participation in exhibitions, fairs, or exhibitions abroad.

What documents do businesses need to prepare?

According to Article 30 of Decree 98/2021/ND-CP on the management of medical devices, the dossier for registration of circulation includes:

Case	Document need preparing
1. Application for a new circulation number for medical devices with corresponding national technical standards.	a) Document requesting a new circulation number. b) ISO 13845 Certification. c) Letter of Authorization (LOA). d) Certificate of Warranty Eligibility (except for single-use medical devices as specified by the owner of the medical device or documented proof of no warranty). e) Circulation certification. f) General technical dossier for medical equipment as per ASEAN regulations (hereinafter referred to as the CSDT dossier). g) Certificate of Compliance.
2. Application for a new circulation number for medical equipment, which is a measuring instrument, must have the sample approved according to legal regulations on measurement.	a) Document requesting a new circulation number. b) Decision approving the sample. c) ISO 13845 Certificate. d) Letter of Authorization (LOA). e) Certificate of Warranty Eligibility (except for single-use medical devices as specified by the owner of the medical device or documented proof of no warranty). f) Circulation certificate. g) General technical dossier for medical equipment as per ASEAN regulations (hereinafter referred to as the CSDT dossier).
3. Application for a new circulation number for other medical equipment. In cases of expedited issuance as stipulated in Clause 2, Article 29 of Decree No. 98/2021/NĐ-CP.	a) Document requesting a new circulation number. b) Documents as specified in points b, c, and d of Clause 1 of this Article. c) Circulation certificate issued by one of the reference countries. d) Circulation certificate and Import License or Circulation Number or Registration Certificate đ, Quality Evaluation Certificate issued by the authorized agency of Vietnam for in vitro diagnostic medical devices, except for the following cases: – Belonging to the list A, B in Appendix 2 of the In Vitro Diagnostic Medical Device Agreement in Europe and has been issued a Certificate of Free Sale by one of the EU member countries, the UK, Switzerland. – Belonging to the list A, B in Appendix 2 of the In Vitro Diagnostic Medical Device Agreement in Europe and has been issued a Market Authorization by one of the reference countries. – Not belonging to the list A, B in Appendix 2 of the In Vitro Diagnostic Medical Device Agreement in Europe but has been issued a Market Authorization by one of the reference countries. – Belonging to the list announced by the Minister of Health. e) Technical dossier for medical equipment according to ASEAN regulations (CSDT dossier).
4. Application for a new circulation number for medical equipment falling under emergency cases as stipulated in Clause 3, Article 29 of this Decree.	a) Document requesting a new circulation number. b) Documents as stipulated in points b, c, and d of Clause 1 of this Article. c) Circulation certificate or emergency use permit for imported medical devices. d) Technology transfer agreement. đ) Outsourcing agreement. e) Certificate of inspection or quality assessment of the product issued by one of the units on the list published on the Electronic Information Portal of the Ministry of Health if it falls into one of the following cases: – Medical devices manufactured domestically. – Medical devices authorized for circulation and emergency use by competent authorities in EU member countries, the UK, and Switzerland but not included in the list of common products announced by the Health Security Committee of the European Union (EUHSC). g) Common Technical Dossier (CTD) for medical devices as regulated by ASEAN (hereinafter referred to as CTD).
5. Application for a new circulation number for other medical equipment	a) Document requesting a new circulation number. b) Documents as specified in points b, c, d, and e of Clause 1 of this Article. c) Results of the evaluation of the Common Submission Dossier (CSDT) by the unit designated by the Minister of Health, accompanied by the CSDT. d) For in vitro diagnostic medical devices that are test drugs, standard substances, and control materials, they must also have a quality certificate issued by the authorized agency of Vietnam. đ) For chemicals and formulations intended solely for disinfecting medical devices, they must have a Component Test Sheet, indicating the content of active disinfectant ingredients, issued by the unit that has declared the conditions for conducting tests according to the law on the management of chemicals, insecticides, and antibacterials used in household and medical fields; Evaluation test sheet for the biological effectiveness of the product and its side effects on test participants, issued by the unit that has declared the conditions for testing according to the law.

 

Procedure for Registering Circulation Applicable at Medgate

– Customer Information Reception: Consultants handle issues related to the registration for circulation, applicable to medical devices of Class C, D

– Service Consultation: Specialists engage in discussions with customers regarding the implementation process, cost quotations, negotiation, and contract signing.

– Service Deployment: Consultants guide customers in preparing the necessary documentation. After the customer provides the required documents according to regulations, the consultant proceeds to draft the documents, submit the dossier, and address issues related to the dossier until that is officially returned with the registration number.

– Communicate the registration results to the customer.

Medgate – A reputable service provider for registering circulation applicable to Class C, D Medical Devices in Vietnam.

With an experienced team of professionals, Medgate is confident in being a reliable partner for customers in introducing medical equipment products to the Vietnamese market, adhering strictly to the regulations of the Ministry of Health.

– Time-saving, avoiding multiple additions to the dossier that may impact the customer’s business plans.

– The team of specialists possesses high professional qualifications and years of experience in the field of medical devices, both domestically and internationally.

For consultation on MEDGATE’s registration and import-export services, please contact us at the hotline 098.546.1894 or send a message via our fan page for immediate assistance.