Are you having difficulties in reissuing your medical equipment import license? Are you uncertain about the current legal requirements and procedures? The following article provides clear, accurate, and detailed information on the reissuance process, relevant legal grounds, and frequently asked questions. Contact NPLaw for prompt consultation and professional support.

I. The need for reissuance of medical equipment import licenses

Enterprises may need to apply for reissuance of medical equipment import licenses in the following circumstances:

  • Lost or damaged license: A certified copy is required for submission to the competent authority.
  • Inaccurate information on the license: Adjustments must be made to ensure information reflects the actual situation.
  • Expired license: Renewal procedures must be completed to continue import activities.

II. Legal provisions on reissuance of medical equipment import licenses

1. Definition of reissuance of medical equipment import license

Reissuance of a medical equipment import license refers to an administrative procedure conducted by a competent State authority that enables an enterprise to continue importing medical equipment lawfully. Depending on specific circumstances, such as loss, damage, expiration, or change of information, the procedure may vary accordingly.

2. Conditions for reissuance of medical equipment import license

All conditions for license-related procedures (including initial registration, amendment, or reissuance) must comply with the provisions of Decree No. 98/2021/NĐ-CP and Decree No. 07/2023/NĐ-CP, including:

  • Compliance with requirements concerning facilities, personnel, and quality management systems.
  • Assurance that the medical equipment satisfies safety and quality standards.
  • Submission of a complete and valid dossier.

3. Dossiers and procedures for reissuance of medical equipment import licenses

Important note: Decision No. 2962/QĐ-BYT abolishes the reissuance procedure in cases where the license remains valid but is lost or damaged. Instead, the enterprise must apply for a certified copy. Depending on the particular case, dossiers and procedures will differ, as follows:

(a) Case where the license is still valid but lost or damaged (application for certified copy):

  • Dossier:
    + A written request for a certified copy, clearly stating the reason.
    + A copy of the Enterprise Registration Certificate.
    + Documents proving prior issuance of the license (e.g., a copy of the old license, notification of dossier acceptance, etc.).
  • Procedure:
    + Submission of a dossier to the Ministry of Health or the Department of Health (depending on the original issuing authority).
    + Upon verification of validity, the competent authority will issue a certified copy.

(b) Case where the license has expired or requires information amendment:

Dossiers and procedures must comply with the provisions on new registration or amendment of import licenses under Decree No. 98/2021/NĐ-CP and Circular No. 05/2022/TT-BYT, specifically:

  • Dossier:
    + Written request (in prescribed form).
    + Enterprise Registration Certificate.
    + Documents proving compliance with facility and personnel requirements (if any changes).
    + Documents concerning the medical equipment (manufacturer, technical specifications, quality certificates, etc.).
    + Power of attorney (if applicable).
  • Procedure:
    + Submission of a dossier to the Ministry of Health (for Class C and D medical equipment) or the Department of Health (for Class A and B medical equipment).
    + Upon approval of the valid dossier, the authority will issue the corresponding license or certified copy.

III. Questions on reissuance of medical equipment import licenses

1. Which authority is competent to reissue medical equipment import licenses?

The competent authority is the Ministry of Health (for Class C and D medical equipment) or the Department of Health (for Class A and B medical equipment), as provided under Decree No. 98/2021/NĐ-CP.

2. What is the processing time for reissuance?

According to Article 28 of Decree No. 98/2021/NĐ-CP, the processing time is five (05) working days from the date of receipt of a complete and valid dossier. Enterprises should prepare thoroughly to avoid delays.

3. If a medical equipment import license expires, should the enterprise apply for renewal or amendment?

  • If renewal is permitted: The enterprise shall proceed with the renewal procedure as prescribed in Decree No. 07/2023/NĐ-CP, with dossier requirements set out in guiding documents.
  • If renewal is not permitted: The enterprise must implement a new registration procedure for the import license.

4. Can a license that is both lost and expired be reissued?

A certified copy cannot be issued once the license has expired. However, the enterprise may apply for a new import license, provided all current legal conditions are met. The dossier for new registration will generally mirror the original registration dossier, supplemented with proof of loss (e.g., a police confirmation report).

IV. Legal consultancy services on reissuance of medical equipment import licenses

The above article by NPLaw on reissuance of medical equipment import licenses aims to provide enterprises with comprehensive legal understanding and practical guidance. With its team of experienced lawyers and legal specialists, NPLaw is always ready to accompany, advise, and assist clients in all legal matters related to import licensing procedures. For further support, please contact: