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Medical Devices Registration in Vietnam

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    Introduction

    The process of medical devices registration in Vietnam is overseen by the Department of Medical Equipment and Construction (DMEC), operating under the Ministry of Health (MOH). The regulatory landscape for registration is currently undergoing significant changes, with the introduction of Decree No. 98/2021, replacing previous regulations.

    As of January 1, 2022, Decree No. 98/2021 has come into effect, signaling a transition period for compliance. However, there’s a notable scarcity in the issuance of Market Authorization (MA) Licenses for Class C and D products since the implementation of the new decree. Additionally, previously issued Import Licenses have been extended until December 31, 2024, as per Decree 07/2023.

    For companies engaging in the export of medical devices to Vietnam, it’s crucial to stay abreast of these regulatory changes and ensure compliance with the updated requirements. Adhering to the new regulations is essential to navigate the registration process smoothly and maintain market access for medical devices in Vietnam.

    Who can register a medical device in Vietnam?

    In Vietnam, the registration of medical devices is governed by specific regulations, with certain criteria for eligibility. Only local companies with a valid Establishment License from the Local Department of Planning and Investment are authorized to register medical devices. These organizations include Vietnamese enterprises, cooperatives, household businesses owning or trading medical devices, and standing representative offices of foreign traders with ownership or authorization of medical devices.

    For foreign manufacturers seeking registration in Vietnam, there are several avenues available:

    • Establish a Legal Entity: Setting up a subsidiary in Vietnam involves obtaining an investment certificate and business license from the local Department of Planning and Investment.
    • Appoint a Local Importer or Distributor: Foreign manufacturers can appoint a local importer or distributor with a valid establishment license to register the medical devices on their behalf.
    • Engage an Independent Third Party: Companies like Andaman Medical offer services as a Local Authorized Representative, holding a valid Medical Device Establishment License. Acting directly on behalf of foreign manufacturers and distributors, Andaman Medical handles the registration process for all classes of medical devices (A, B, C, and D), ensuring compliance and facilitating market entry. This option provides flexibility in appointing importers or wholesalers without affecting the product license, while Andaman Medical also serves as a licensed importer of medical devices.
    Medical-Devices-Registration-in-Vietnam

    Key Regulations for Medical Devices Registration in Vietnam

    • Decree No. 98/2021/ND-CP: This decree, effective January 1, 2022, outlines crucial regulations governing the registration process for medical devices in Vietnam.
    • Amendment to Decree No. 43/2017: Decree No. 111/2021 introduces amendments to Decree No. 43/2017, focusing on updating labeling requirements for medical devices.
    • Circular 05/2022: Circular 05/2022 provides a comprehensive list of products that necessitate registration before importation into Vietnam.
    • Decree 07/2023 (EN/VN): Decree 07/2023 extends the validity of Import Licenses and postpones the implementation of CSDT application requirements. Additionally, it offers further clarifications on regulatory aspects.

    Previous Governing Regulations

    • Circular No. 30/2015/TT-BYT: Enforced since 2015 and set to phase out by December 31, 2022.
    • Decree No. 36/2016/ND-CP: Effective from January 1, 2020, but superseded by Decree 98/2021.
    • Decree No. 169/2018/ND-CP: Amendment to Decree 36, introducing fast-track approval and CSDT requirement, now replaced by Decree 98/2021.
    • Decree No. 03/2020/ND-CP: Amended Decree 36, outlining the implementation process of new regulations, now replaced by Decree 98/2021.

    Registration Fees and Timeline

    In Vietnam, medical device registration follows a classification system aligned with GHTF guidelines, ranging from Class A to Class D based on risk level. Previously, classification required local certification, but now the Registration Holder can classify the product within the application process.

    Class DMEC Fees / MA Licenses Timeline
    Class A VND 1 million (~US$44) 7-10 working days
    Class B VND 3 million (~US$130) 7-10 working days
    Class C VND 6 million (~US$245) 6-12 Months
    Class D VND 6 million (~US$245) 6-12 Months

    Class A And B Medical Devices

    Class A and B devices are subject to a Notification process that is overseen by the provincial offices of the MOH. By handling these administrative reviews, the central MOH has more time to focus on Class C and D applications. Class A and B MA License applications that leverage Reference Country approval are typically approved within 1 week.

    Class C And D Medical Devices

    Class C and D devices listed in Circular 30/2015 required an Import License or Market Authorization (MA) License prior to importing and marketing in Vietnam. Existing Import Licenses will now expire on December 31, 2024, while MA licenses will remain valid indefinitely. A full list of products found in Circular 30/2015 can be found further below and include ventilators, infant incubators, pacemakers, x-ray machines, MRIs, hemodialysis devices, etc.

    Class C and D devices not listed in Circular 30 can continue to be freely imported through December 31, 2024, with only a classification document. This being said, manufacturers of these products are encouraged to obtain a MA License at their earliest convenience.

    Products with a Reference Country approval or the same national standards will avoid the Technical Review and we planned to be approved in about 20 working days. However, the MOH has experienced significant delays and have only approved a very limited amount of Class C/D MA Licenses. Class C and D applications without a Reference Country approval or national standards will need to undergo a Technical Review which could take up to 90 days.

    Medical-Devices-Registration-1

    What documents are required to register medical devices in Vietnam?

    • Legal Documentation:

      • Free Sale Certificate: A document certifying that the medical device is legally available for sale in its country of origin.
      • Letter of Authorization: A letter authorizing a representative or agent to act on behalf of the manufacturer in the registration process.
      • ISO 13485 Certificate: Certification demonstrating compliance with international quality management standards for medical devices.
    • Technical Documentation:

      • Classification Result: Confirmation of the medical device’s classification according to Vietnamese regulations.
      • Technical Brief: Detailed technical specifications and characteristics of the medical device.
      • Instruction for Use (Vietnamese): Comprehensive instructions for using the medical device, translated into Vietnamese for local understanding.
      • Labelling: Labels affixed to the device containing essential information such as product name, manufacturer details, and usage instructions.
      • Catalogue: A catalogue providing an overview of the medical device’s features and specifications.
    • Additional Requirements for Certain Devices:

      • Summary of Clinical Trial Data: Required for Class C and D medical devices invasive to the human body, providing a summary of clinical trial results and safety data.
      • Measurement Instruments: Measurement devices necessitate sample approval, inspection, and calibration under the responsibility of the Ministry of Science and Technology.

    Ensuring compliance with these documentation requirements is essential for successfully registering medical devices in Vietnam. Each document plays a crucial role in demonstrating the safety, quality, and efficacy of the device, ultimately facilitating market access and regulatory approval.

    Technical Documents

    Document Name Class A Class B Class C Class D
    Executive Summary Yes Yes
    Device Description Yes Yes Yes Yes
    Labelling and IFU Yes Yes Yes Yes
    Risk assessment Yes Yes
    PMS report Yes Yes
    Declaration of conformity Yes Yes
    Summary of Design V&V Yes Yes
    Summary of clinically testing data Yes Yes
    Essential Principles and methods Yes Yes
    Physical Manufacturer Information Yes Yes Yes Yes

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