On November 19, 2024, the Infrastructure and Medical Device Administration (IMDA) issued Letter No. 519/HHTB-DKKD, requesting enterprises to provide details about class C and class D medical devices with import licenses that were set to expire on December 31, 2024. The IMDA sought this information to synthesize, report, and propose solutions to the Ministry of Health and the Government. This effort aimed to address challenges faced by businesses and ensure an uninterrupted supply of medical equipment, thereby preventing any negative impact on medical examination and treatment activities in healthcare facilities.
Key Details of the Request
The IMDA had asked enterprises to submit the following information for relevant medical devices:
- Import License Numbers: For class C and class D medical devices with licenses expiring on December 31, 2024.
- Medical Device Name: Full name of the product.
- Product Model: Specific model details.
- Application Number: Submitted for registration license to replace the expiring import license.
- Status of Registration Dossier:
- Approved: Include the registration number.
- Not Yet Approved: Indicate this status clearly.
- Shelf-Life Note: Mark an “X” in the “Note” column for medical devices with a short shelf life (12 months or less).
Submission Timeline and Process
- Deadline: Enterprises were required to submit their information by 5:00 PM on November 25, 2024.
- Submission Method: : Letters were to be sent directly to the IMDA via email at hainh.httb@moh.gov.vn.
Andaman Medical’s Role and Assistance
Andaman Medical actively contacted all affected clients to assist in gathering the necessary information and ensuring compliance with IMDA’s requirements.
Additional Resources and Contact Information
32. Letter 519HTTB DKKD Request to Provide Info on MD with Import License Expiring on 31 Dec 24.pdf (Vietnamese).
Should you have any questions or need assistance, please reach out to us at sales@andamanmed.com or click the button below.