AUTHORIZED REPRESENTATIVE (MEDICAL DEVICES VIETNAM)

REGULATING MEDICAL DEVICES

To place medical devices on the market in Vietnam, non-local companies must comply with regulatory requirements established by the Vietnam Ministry of Health (MOH) and the Law on Medical Examination and Treatment.

COUNTRY AUTHORIZED REPRESENTATIVE RESPONSIBILITIES

Non-local companies are required to appoint an authorized representative in Vietnam known as a registration holder.

The registration holder acts as an intermediary between the non-local company and Vietnamese authorities.

They assist with regulatory submissions and communication with Vietnamese authorities.

Registration Holders have the authority to authorize an unrestricted count of distributors to engage in imports under the marketing authorisation license, and they can also participate in public tenders.

Here is a summarized overview of these requirements, with an emphasis on the role of the authorized representative:

1. Product Registration:

• Non-local companies must register their medical devices with the Vietnam MOH before they can be legally marketed and sold in Vietnam.
• Registration involves submitting comprehensive documentation regarding the device's safety, quality, and efficacy.

2. Authorized Representative:

• Non-local companies are required to appoint an authorized representative in Vietnam.
• The authorized representative acts as an intermediary between the non-local company and Vietnamese authorities.
• They assist with regulatory submissions and communication with Vietnamese authorities.

3. Device Classification:

• Medical devices are classified based on risk, and the classification determines the regulatory pathway and requirements.
• Non-local companies must determine the classification of their devices to understand specific requirements.

4. Quality Management System (QMS):

• Medical device companies must establish and maintain a QMS compliant with international standards, such as ISO 13485.
• The Vietnam MOH may audit the QMS to ensure compliance.

5. Labeling and Packaging:

• Medical device labeling and packaging must comply with Vietnamese regulations, including language requirements and specific labeling content.
• The authorized representative may assist in ensuring proper labeling and packaging.

6. Clinical Data and Testing:

• Depending on the device's risk classification, clinical data and testing may be required to demonstrate safety and efficacy.
• Non-local companies must provide this data as part of the registration process.

7. Post-Market Surveillance:

• Companies must establish a system for monitoring and reporting adverse events or product defects to the Vietnam MOH.
• The authorized representative may assist with reporting obligations.

8. Fees and Payments:

• Non-local companies are typically required to pay registration fees and annual renewal fees.
• The authorized representative can assist in handling these financial transactions.

9. Compliance with Vietnamese Laws:

• Non-local companies must comply with all Vietnamese laws and regulations concerning medical devices.
• The authorized representative plays a role in ensuring ongoing compliance.

10. Notification of Changes:

• Any changes to the medical device or its manufacturing process must be reported to the Vietnam MOH through the authorized representative.

11. Periodic Inspections:

• The Vietnam MOH may conduct periodic inspections of the manufacturing facilities, storage facilities, and records of non-local companies through the authorized representative.

In summary, non-local companies aiming to market medical devices in Vietnam must navigate various regulatory requirements. The authorized representative, a mandatory role, plays a crucial part in facilitating compliance, regulatory submissions, and communication with Vietnamese authorities.

Effective collaboration with the authorized representative is essential for successfully navigating the regulatory landscape in Vietnam.