Vietnam MoH Audits License Holders for Compliance

The Vietnam Ministry of Health (MoH), Medical Devices Division, is responsible for ensuring compliance with the Medical Device Rules among entities acting as license holders for medical devices in Vietnam. As part of this mandate, the MoH periodically conducts audits of these license holders to ensure that they are adhering to the required standards and regulations.

Recent Audit Experience with Asia Actual Vietnam

Recently, Asia Actual Vietnam underwent a thorough audit conducted by the MoH. The audit was comprehensive, covering critical areas of compliance such as licensing, documentation, and operational procedures (Announcement of Post-Check Plan).

Timing and Process of the Audits

The MoH typically conducts these audits on an annual basis, targeting around 20-40 companies depending on the size of the city or province. Here’s an outline of the audit process:

1. The MoH requires the Health Department of each province to randomly select 20-40 companies for inspection.
2. The MoH announces the list of companies scheduled for audits and sends a notification letter detailing the timeline and inspection contents. For example, Asia Actual Vietnam received a notification letter (English Version) on July 4, 2024, to prepare for the post-check audit.
3. The inspection team usually consists of four inspectors who review various aspects of the company’s operations.

Areas of Focus During the Audit

During our recent audit, the MoH reviewed several specific areas, including:

• Business License Verification: The Health Department examined the original business license of Asia Actual Vietnam.
• License Overview: Asia Actual had 93 licenses on the MoH portal as of August 14, 2024, including 92 Marketing Authorization (MA) Licenses and 1 GDPMD (Good Distribution Practice for Medical Devices) license.
• GDPMD Compliance: The inspectors reviewed documents related to the warehouse, car license, and certificates of technical personnel: that they hold Biology degree and have completed a medical device training course.
• Dossier Review for Medical Device Classes:
  • Class A/B Devices: Classification, Free Sales Certificate (FSC), Letter of Authorization (LOA), and ISO 13485 documentation.
  • Class C/D Devices: Similar documentation requirements as Class A/B.
• Operational Aspects: Importation activities, price declarations, promotional activities, and VAT invoices were inspected.
• Document Presentation: The Health Department requested ten applications to be printed and require the originals of FSC, LOA, warranty documents, or single-use certificates to be shown.

Post-Inspection Process

Asia Actual was permitted to present the required documents at the headquarters of the Health Services of Ho Chi Minh City on August 28, 2024. The company representative and inspection team signed the “Memo of Medical Equipment Inspection” (English Version) on August 14, 2024. After reviewing ten applications and the original copies on August 28, the inspectors issued the “Memo of Inspection Conclusion” with an official stamp (English Version).

Asia Actual Vietnam successfully completed the audit without any penalties and will likely not face another audit for at least 2 years.

Consequences of Non-Compliance

The repercussions for non-compliance can vary based on the severity of the findings:

• Minor Non-Compliance: Issues such as documentation errors may lead to recommendations for corrective actions without immediate penalties.
• Major Non-Compliance: More severe breaches could result in a warning letter, which, if not addressed, may escalate to fines or license suspension.

Vietnam License Holding Audit Conclusion

Overseas manufacturers are encouraged to work closely with their local license holders in Vietnam to ensure thorough preparation for these audits. A proactive approach, including regular internal audits and adherence to all regulatory requirements, will help mitigate compliance risks.

Navigating MoH audits requires a comprehensive understanding of the compliance landscape and meticulous preparation. Asia Actual Vietnam’s recent audit experience demonstrates our commitment to maintaining high standards and robust compliance protocols.

Asia Actual VietNam is positioned to make market entry as efficient as possible and free of any compliance worries. Please contact us for support in VietNam.