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  • The process to obtain D-class medical device registration with the Vietnam Ministry of Health (MOH) typically takes between 6 to 12 months. However, the exact timeline can vary depending on several factors, including the completeness of the application, the complexity of the device, and whether the MOH requires additional documentation or an on-site inspection.
  • Yes, D-class medical device registration with the Vietnam Ministry of Health (MOH) does require ongoing compliance, and while the initial registration is typically valid for 5 years, there is an annual review process that manufacturers must adhere to.
  • Handling D-class medical device registration with the Vietnam Ministry of Health (MOH) serves several important purposes for manufacturers and the healthcare system in Vietnam.
  • The cycle time for D-class medical device registration with the Vietnam Ministry of Health (MOH) generally takes 6 to 12 months, depending on the complexity of the device and the completeness of the application. However, several factors can affect the timeline, such as the responsiveness of the applicant, the thoroughness of the review process, and whether any additional information or clarifications are required by the Drug Administration of Vietnam (DAV).
  • D-class medical device registration with the Vietnam Ministry of Health (MOH) refers to the regulatory process for registering high-risk medical devices in Vietnam. In the context of Vietnam's medical device regulatory framework, medical devices are classified into four categories (Class A, B, C, and D) based on their potential risk to patients and users.
  • To register a D-class medical device with the Vietnam Ministry of Health (MOH), you need to follow a detailed and regulated process due to the high-risk nature of D-class devices. Below is a step-by-step guide on how to apply for D-class medical device registration with the Vietnam MOH.
  • Applying for D-class medical device registration with the Vietnam Ministry of Health (MOH) involves several key steps. D-class devices are considered high-risk medical devices, so the application process is more comprehensive than for lower-risk devices.
  • Handling D-class medical device registration with the Vietnam Ministry of Health (MOH) requires careful attention to detail due to the high-risk nature of these devices. D-class devices are subjected to a comprehensive registration process to ensure they meet safety, efficacy, and quality standards