Procedures for new issuance of medical equipment import license

New issuance of medical equipment import license is an important process, helping to ensure the safety and quality of medical products brought into the market. You may have difficulty understanding the steps necessary to complete this procedure. Through the article below, Long Phan will provide detailed instructions for each stage, helping you easily grasp and implement in the most effective way.

Cases of new issuance of medical equipment import licenses

Pursuant to Clause 1, Article 48 of Decree 98/2021/ND-CP, cases of new issuance of medical equipment import licenses are also cases where medical equipment import licenses must be issued because of requirements. The new level is only issued when:

• Medical equipment requested for import license for the first time;
• The import license has expired and a new license must be issued.

Therefore, the cases of new issuance of medical equipment import licenses are:

• In some cases, medical equipment without a circulation number is imported;
• Used medical equipment: Imported for research and training purposes or temporarily imported and re-exported for display, introduction, and participation in trade fairs and exhibitions.

Components of application for new medical equipment import license

The application for a new license to import medical equipment is in Clause 2, Article 48 of Decree 98/2021/ND-CP including:

• Application for license.
• Documents describing equipment techniques in Vietnamese.
• Certificate of quality standards of the production facility.
• For imports for research: Copy of decision approving the research topic.
• For training: Original training program.
• For inspection: Written confirmation from the inspection unit.
• For aid: Copy of aid approval decision.
• For gifts: Copy of documents showing the content of the gift.
• For humanitarian medical examination and treatment: Documents proving permission for circulation.
• For special diagnoses: Documents proving permission for circulation.
• For personal treatment: Copy of doctor’s prescription.
• For fairs and exhibitions: Copy of program and contract.
• For urgent needs, disease prevention, and overcoming the consequences of natural disasters, the following additional documents are required:
  • Document approval from the competent authority.
  • Documents proving authorization for circulation or emergency use.

Steps to renew medical equipment import license

Pursuant to Clause 3, Article 48 of Decree 98/2021/ND-CP, the steps for granting a new medical equipment import license are:

Step 1: Submit application: The organization requesting an import license submits the application to the Ministry of Health through the information system for handling administrative procedures of the Ministry of Health.

Step 2: Appraisal of documents

• If the dossier is complete, the Ministry of Health will organize an appraisal to issue an import license within 15 working days (2 days for emergencies).
• If the license is not granted, the Ministry of Health must notify the reason.

Step 3: Add profile

If the dossier is not complete, the Ministry of Health will notify the additional request within 10 days (2 days for emergencies). The organization must comply with the requirements; If not completed within 30 days, the application must be resubmitted from the beginning.

Step 4: Licensing:

If there are no additional requirements, the Ministry of Health will issue a license and send the license to the organization and customs authority.

The time limit for granting new medical equipment import licenses

Pursuant to the provisions of Clause 3, Article 48 of Decree 98/2021/ND-CP, the time limit for resolving new issuance procedures is 15 working days from the date of receiving the dossier, or 02 working days for equipment. Medical equipment that does not have a circulation number is imported to meet urgent needs

Consulting services and support for granting new licenses to import medical equipment

During the process of granting a new license to import medical equipment, Long Phan is proud to provide you with a full consulting service, including:

• Consulting on regulations related to licensing procedures for importing medical equipment;
• Support in preparing and completing documents according to regulations;
• Support for submitting documents to competent authorities;
• Monitor progress and notify document processing status during the appraisal process;
• Consulting to resolve arising problems;
• Update changes in legal regulations related to the import of medical equipment;
• Provide solutions and strategies to optimize the import process to minimize risks and costs.

Applying for a license to import medical equipment is a complex process, requiring accuracy and strict compliance with legal regulations. Using professional consulting and support services not only helps businesses save time and costs but also minimize legal risks. If you have any questions or need consulting services on procedures for licensing medical equipment import, please contact us via hotline 0906735386.