On December 9, 2024, the Vietnam Ministry of Health (MoH) issued Official Dispatch No. 7614/BYT-HTTB, addressing the supply of medical devices whose import licenses will expire on December 31, 2024. This notice outlines measures to ensure an uninterrupted supply of medical devices while emphasizing compliance with regulatory requirements.
Key Actions for Medical Device Importers
- Devices with Existing Import Licenses:
- Medical devices with valid import licenses that have already been imported into Vietnam can continue circulation and use if they comply with Article 22 of Decree No. 98/2021/ND-CP (amended and supplemented by Decree No. 07/2023/ND-CP).
- Registration Applications for Renewal:
- For devices with import licenses expiring on December 31, 2024, and pending registration approvals, the MoH advises:
- Review, update, and supplement documents as necessary.
- Re-submit applications on the MoH’s online portal to ensure compliance with updated regulations.
- Approved applications will be processed promptly following appraisal.
- For devices with import licenses expiring on December 31, 2024, and pending registration approvals, the MoH advises:
- Proactive Planning by Businesses:
- While awaiting registration results, businesses should plan their orders based on the validity of current import licenses.
- Ensure compliance with ongoing contracts to prevent supply disruptions.
Guidance for Medical Facilities
Medical facilities are encouraged to:
- Review and adhere to regulations on medical device management.
- Take proactive measures to ensure compliance and uninterrupted access to necessary medical devices.
Addressing Difficulties and Challenges
The MoH urges all units to promptly notify the Ministry if they encounter challenges or difficulties during implementation. This will enable timely resolution and ensure regulatory compliance.
Further Information
For additional details, please refer to the official document: Vietnam Ministry of Health Issues Official Notice.pdf (Vietnamese)
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