A list of recently updated articles regarding medical device regulatory updates from the MOH and other governing bodies in Vietnam.

Vietnam MoH Audits License Holders for Compliance

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Asia Actual Vietnam completed an MoH audit, covering key compliance areas including licensing, documentation, and operational procedures.

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What is CSDT Documentation?

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Manufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.”

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Key Takeaways from VietNam’s CSDT Conference

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On June 28, 2024, The Vietnam Ministry of Health hosted a training session on how to prepare an ASEAN MDD Common Standard Technical Document.

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Medical Device Risk Classification Problems in Vietnam

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According to a report published on May 7th, 2024, contractors have been apprehended misrepresenting IVD and Medical Device risk classification to participate in bidding parties.

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Vietnam’s MoH Updates Class C and D Application Requirements

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Per Decree 07/2022, the application requirements for new Class C and D applications submitted to the Vietnamese Ministry of Health (MoH) after January 1, 2024 will need to be in ASEAN Common Submission Dossier Template (CSDT) format, with the addition of a Vietnamese IFU.

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Vietnam Requires Resubmission of Many Medical Device Registration Applications

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All unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.

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Vietnam’s MOH Holds Conference on Price Declaration

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The conference was held to provide clarity to the Price Declaration process and announce the establishment of a new online portal for license holders to declare prices. This comes as many provincial health services, including Ninh Binh and Dak Nong, have not been able to purchase medical products since January 1, 2022.

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Vietnam’s DMEC Provides Update on Issuance of C/D Licenses

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On September 14, 2022, the DMEC held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses.

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The Vietnamese MOH Issues Draft Decree to Address Delays

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On November 15th, the Vietnamese Ministry of Health (MOH) issued a draft decree to amend a number of articles from a previous decree related to the registration of medical devices.

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Vietnam Extends Validity of Medical Device Import Licenses

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On March 3rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. 07/2023/ND-CP (Decree 07/2023), which automatically extended the validity of import licenses to December 31, 2024.

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