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Home Legal basisLegal Documents Vietnam: Amendment and Supplementation of Several Articles of Decree 96/2023/ND-CP regarding Medical Device Management

Vietnam: Amendment and Supplementation of Several Articles of Decree 96/2023/ND-CP regarding Medical Device Management

by nam.nguyen@mednovum.com.vn

Regulatory updates, Vietnam

On 30 December 2023, the Government of Vietnam issued Decree 96/2023/ND-CP detailing several articles of the Law on Medical Examination and Treatment. Furthermore, Article 147 of this Decree has amended and supplemented some articles of Decree 98/2021/NĐ-CP regarding “Medical Device Management.”

The highlighted amendments and supplementations to the articles of Decree 98/2021/ND-CP are as follows:

1.Clause 8 to Clause 18 of Article 147 Decree 96/2023/ND-CP amended and supplemented Chapter IV “Clinical study on medical devices” in Decree 98/2021/ND-CP on Medical Devices Management.

2.Clause 19 of Article 147 Decree 96/2023/ND-CP amended and supplemented Article 30 of Decree No. 98/2021/ND-CP with content as the requirement for the Certificate of Clinical Test Results from a competent Authority for medical devices subjected to clinical testing into the registering application of Class C and Class D medical devices. However, this regulation will only come into effect on 01 January 2026.

3. Prioritization in the processing of the registering Marketing Authorization Code (“MAC”) application of medical devices that fall under one of the following categories:

  • Medical devices that are manufactured in Vietnam.

  • Medical devices have submitted import licenses before January 1, 2022, but have not yet been granted and have MAC applications submitted.

  • Chemicals, preparations with the sole purpose of disinfecting medical devices.

  • Medical devices for implementing new techniques and methods in medical examination and treatment have been officially approved by the Ministry of Health (MOH) but have not yet been issued a MAC in Vietnam.

  • Medical devices having changes in the information such as a change in importer or Applicant, change in the name of the manufacturing site or product owner (with no changes in the address of the manufacturing site or product owner) but without changes in the product code or model as stated in the granted import license or registration license or valid certification of Marketing Authorization.

  • Medical devices with no changes in model but having changes in the product code due to discontinuation of the previous product code in one of the following documents:  import license or registration license or valid certification of Marketing Authorization.

  • MAC applications have been requested to supplement or rejected due to an update on the validity of the Letter of Authorization, ISO 13485, Certificate of Free Sale.

  • MAC applications have been requested to supplement or rejected due to change or supplement the name of the medical device.

4. Prioritization during the review process of MAC applications of medical devices will be carried out as follows:

  • The Applicant shall apply for a form to prioritize processing, including sufficient information regarding the submitted application number on the DMEC platform.

  • The Applicant shall provide supporting documentation corresponding to the cases eligible for prioritized processing.

  • The MOH will examine the request and allow for prioritized processing of the MAC application of the medical device within 10 working days of receiving the requesting applicant and accompanying documents.

  • In cases where prioritized processing is not permitted, MOH will provide a written response stating the reasons for the decision.

If you have any queries about this draft guidance, please contact us at info@mednovum.com.vn.

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