Standard Declaration For Class A, B Medical Devices

Medical devices intended for circulation in the market must undergo classification and subsequently announce the standards applicable to Class A, B medical devices. Additionally, registration for circulation is required for Class C, D medical devices.

 The process of announcing standards for Class A, B medical devices is complex and time-consuming in terms of document preparation and procedures with government agencies. Therefore, inexperienced entities in standard announcements are prone to situations where their documents are returned for supplementation or clarification on paperwork issues, affecting the business plans of the entity.

 Understanding the concerns and anxieties of customers, Medgate provides a service for announcing standards applicable to Class A, B medical devices with a quick turnaround time and reasonable costs.

Legal Basis and Conditions for Declaring Standards Applicable to Class A and B Medical Devices

Legal Basis

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

– Circular 10/2023/TT-BYT  issued on May 11, 2023: Amending and supplementing some provisions of Circular 19/2021/TT-BYT dated November 16, 2021, of the Minister of Health regulating document forms, reports implementing Decree No. 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical devices.

– Circular 19/2021/TT-BYT  issued on November 16, 2021: Regulating document forms, reports implementing Decree No. 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical devices.

– Decree 07/2023/ND-CP  issued on March 3, 2023: Amending and supplementing some provisions of Decree No. 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical devices.

– Circular 05/2022/TT-BYT  issued on August 1, 2022: Detailing the implementation of some provisions of Decree No. 98/2021/ND-CP dated November 8, 2021, of the Government on the management of medical devices.

Conditions for declaring standards applicable to class A and B medical devices

(According to Article 23, Decree 98/2021/ND-CP on the management of medical equipment)

a) Produced at a manufacturing facility that has announced sufficient production conditions for domestically manufactured medical devices.

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

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

What documents do businesses need to prepare?

According to Article 26 of Decree 98/2021/ND-CP on the management of medical devices, the dossier for announcing standards applicable to Class A, B medical devices includes:

1. Document announcing the applicable standards for Type A, B medical devices.

2. ISO 13485 certification valid at the time of application submission.

3. Letter of Authorization (LOA) from the owner of the medical device for the organization named in the announcement of applicable standards, valid at the time of submission (except for cases where businesses or individual business households own the product).

4. Confirmation of warranty conditions issued by the owner of the medical device (except for single-use medical devices or products with documented evidence of no warranty as regulations).

5. Technical description documents for the medical device in Vietnamese, along with technical documentation describing the functions and specifications of the medical device issued by the owner of the medical equipment.

(For test kits, standard substances, in-vitro control materials: technical documents in Vietnamese, along with documentation on raw materials, product safety, production processes, clinical and preclinical research reports, including stability reports).

6. Certificate of conformity as required or the product standard issued by the owner of the medical device.

(For domestically manufactured medical devices, supplement about evaluation results of physical, chemical, microbiological parameters and other criteria by facilities meeting legal requirements for assessment or a Certificate of Quality Assessment issued by Vietnam’s competent authority for in-vitro diagnostic medical devices. Evaluation results must comply with the standards declared by the owner of the medical device).

7. Instructions for use of medical devices.

8. Label samples of the medical device to be used when circulated in the market.

9. Certificate of Free Sale valid at the time of submission for imported medical devices

Process for announcing standards applied at Medgate

– Customer Information Reception: Consultants address issues related to announcing applicable standards for Class A, B medical devices.

– Service Consultation: Consultants discuss the implementation process, cost estimates, negotiate, and sign contracts with customers.

– Service Implementation: Consultants guide customers in preparing necessary documents. After customers provide sufficient documentation as required, consultants draft documents, submit the dossier, and handle issues related to the dossier until the announcement is issued.

– Results Announcement to Customers

Call the Hotline now for advice: 098.546.1894

Medgate – A Reputable Provider of Announcement Services for Application of Standards for Medical Devices in Vietnam

With an experienced team of professionals, Medgate is confident in being a collaborative partner with customers in bringing medical devices  to the Vietnamese market and comply with the regulations set by the Ministry of Health.

– Time Efficiency, Avoiding Document Supplementary Issues Impacting Business Plans: The result turnaround time is within 5-10 days.

– Highly Qualified Team of Professionals with Years of Experience in the Medical Equipment Sector: Medgate’s team consists of highly qualified professionals with extensive experience in the field of medical devices, having worked with both domestic and multinational companies.

Other Services at Medgate

– Classification of medical devices A, B, C, D.

– Registration for circulation of Class C, D medical devices.

– Announcement of eligibility for trading Class BCD medical devices.

– Advertising for medical devices.

– Personnel training.

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.

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