Simplifying the Administrative Procedures in Medical Equipment Sector

As part of the effort of international economic integration, Vietnam is on progress offering specific solutions to speed up the review and simplification of administrative procedures, eliminating cumbersome administrative procedures, reducing cost and helping businesses more convenient in business activities.

On medical equipment sector, on September 1, 2021, the Ministry of Health issued Decision No. 4218/QD-BYT, on the application of the Vietnam National Single Window (VNNSW) for 05 administrative procedures as following:

  • Issuing licenses to import medical equipment.
  • Issuing permits to import medical equipment containing narcotics and precursors.
  • Issuing licenses to import raw materials for the production of medical equipment containing narcotics and precursors.
  • Issuing licenses to export medical equipment containing narcotics and precursors, raw materials for the production of medical equipment containing narcotics and precursors.
  • Issuance of a new free-sale registration number for medical equipment that already has corresponding national technical regulations.

Its will be officially applied from October 1, 2021 for all organizations and individuals manufacturing, trading and importing medical equipment. When it comes to subjects of responsibility, we emphasize a legal digital certificate, whereby the legal representative must have a legal digital certificate to digitally sign documents submitted in the online registration application and commit to the accuracy and truthfulness of the declared content and submitted online records, to unify content between the paper records and the online electronic records created and submitted by the enterprise.

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 Note: This article is for informational purposes only and it is not a legal advice. The content of the article represents its own of TTVN Legal, it subject to change without prior notice.