Procedures for applying for medical devices import license

1. Legal Basis for Importing Medical Equipment

• Law on Customs 2014
• Decree 36/2016/ND-CP
• Decree 169/2018/ND-CP

2. What is Medical Equipment?

• Used individually or in combination as directed by the owner of the medical device for human and other purposes:
• Diagnose, prevent, monitor, treat, and alleviate diseases, injuries, and trauma.
• Test, replace, adjust, and support surgical and physiological processes.
• Support or sustain human life.
• Control conception.
• Disinfect other related equipment.
• Provide necessary and useful information for testing, diagnosing, monitoring, and treating patients through the examination and testing of human specimens.

3. Why is a medical equipment import license required?

4. Forms of medical equipment import license issuance:

5. Procedures for Obtaining an Import License for Medical Equipment

5.1. Classification of Medical Devices for Import Procedures

• Group 1: Low-risk medical devices (Type A)
• Group 2: Medium-low risk (Type B), medium-high risk (Type C), and high-risk (Type D) medical devices

• Prepare documents: ISO 13485, Free Circulation Certificate, Product Catalog, CO & CQ (if available), Classification Request Form provided by Thien Di
• Submit documents to Thien Di for classification
• Receive the result: Medical Device Classification Result

5.2. Public Announcement of Standards Applied When Importing Medical Equipment of Type A

• Document for public announcement of standards applied for medical equipment of type A according to the prescribed form.
• Classification form for medical equipment (Thien Di Company can assist with the classification of medical equipment if the Customer has not yet classified it).
• Valid certificate of quality management at the time of dossier submission (ISO 13485).
• Power of attorney from the medical equipment owner to the organization representing the public announcement of applied standards according to the prescribed form, valid at the time of dossier submission.
• Confirmation of warranty eligibility issued by the medical equipment owner according to the prescribed form, except for single-use medical equipment as prescribed by the medical equipment owner or with documentation proving that there is no warranty.
• Technical summary of medical equipment in Vietnamese according to the prescribed form, attached with technical documentation describing the functions and technical parameters of the medical equipment issued by the medical equipment owner.
• Certificate of conformity or product standard issued by the medical equipment owner, accompanied by the results of the evaluation of physical, chemical, microbiological and other parameters by an organization qualified according to the regulations on conformity assessment for domestically produced medical equipment. The evaluation results must comply with the standards declared by the owner.
• Instructions for use of medical equipment.
• Label sample to be used for circulation in Vietnam of medical equipment.
• Valid free circulation certificate at the time of dossier submission for imported medical equipment.

• The dossier for public announcement of applied standards must be prepared in 1 set.
• For the Certificate of Quality Management: Submit a scanned copy from the original or a certified copy or a copy confirmed by the organization representing the public announcement of applied standards. If the Certificate of Quality Management is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the regulations of law.
• If a copy confirmed by the organization representing the public announcement of applied standards is submitted, the original must be presented for comparison when submitting the dossier or a data source must be provided for the receiving agency to verify the validity of these documents.
• For the free circulation certificate: Submit a consular legalized copy or a certified copy of the consular legalized copy.
• If the free circulation certificate is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the regulations of law.
• If the free circulation certificate does not specify the expiry date, the expiry date of the free circulation certificate is calculated as 36 months from the date of issue.
• For the power of attorney of the medical equipment owner and the certificate of warranty eligibility: For imported medical equipment: Submit a consular legalized copy or a certified copy of the consular legalized copy.
• For the Certificate of Conformity or the Product Standard declared by the medical equipment owner: Submit a certified copy by the organization representing the public announcement of applied standards. If the Product Standard is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the regulations of law.
• For the instructions for use of medical equipment: Submit a Vietnamese copy certified by the organization representing the public announcement of applied standards.
• For the label sample: Submit a sample label certified by the organization representing the public announcement of applied standards. The label must meet the prescribed requirements.

• Competent authority: Department of Health where the head office of the importing company is located. Submit online at: dmec.moh.gov.vn
• Time to receive results: 5-15 working days depending on the time (the epidemic period is longer than usual).
• Implementation procedure:
  • The establishment responsible for putting the medical equipment on the market is responsible for sending the dossier for public announcement of applied standards according to the prescribed regulations to the Department of Health where the establishment is located.
  • Upon receiving a complete and valid dossier, the Department of Health shall issue a Receipt of Dossier for Public Announcement of Applied Standards according to the prescribed form to the establishment.
  • Within 03 working days from the date on the Receipt of Dossier, the Department of Health is responsible for publicly disclosing the following information on the electronic portal: Name, classification, manufacturing establishment, country of origin of medical equipment; circulation number of medical equipment; name and address of medical equipment owner; name and address of circulation number owner; name and address of medical equipment warranty establishment and dossier for public announcement of applied standards of medical equipment.

5.3. Customs Clearance Procedures for Importing Medical Equipment

• Import Customs Declaration Form
• Medical Device Classification Certificate Type A
• Ministry of Health's Confirmation for 5% VAT Rate Application
• Commercial Contract
• Certificate of Origin
• Bill of Lading
• Commercial Invoice
• Packing List

• HS Code: 63079040.
• Tax Rate: 7.5% Import Duty (Preferential Import Duty 5%) and 5% VAT
• Goods with Form D Certificate of Origin enjoy 0% Import Duty
• Labels must be accurate as per the classification. Otherwise, there will be additional costs during inspection.

6. Application for a New Medical Device Import License

• Application form for a new import license, completed by the applicant organization or individual.
• Valid Certificate of Free Sale for the type of medical device to be imported, issued by the competent authority of the exporting country.
• Valid ISO certificate of the manufacturer's quality management system.
• Power of attorney from the owner of the medical device to the organization or individual importing the device, in accordance with the form prescribed in Appendix III.
• Technical document describing the type of medical device to be imported in Vietnamese, in accordance with the form prescribed in Appendix IV.
• Catalog describing the functions and technical specifications of the type of medical device to be imported.
• Clinical evaluation documents and user manual provided by the owner or manufacturer for medical devices listed in Item 49 of Appendix I.
• Report on the import results of medical devices up to the time of submission of the application for a new import license, in case the import license has expired without being renewed in accordance with Clause 2, Article 5 of Circular 30/2015. The report on the import results of medical devices must be made in accordance with the form prescribed in Appendix VI.

7. Things to keep in mind when preparing an import dossier:

• Submit the original or a certified copy of the FCC. If submitting a stamped copy by the importing organization or a signed copy by the importing individual, the original must be presented for comparison.
• If the FCC is issued by a foreign agency, it must meet the following requirements:
  • If the language used in the FCC is not English or Vietnamese, it must be translated into Vietnamese.
  • It must be consularized according to the regulations of Decree No. 111/2011/ND-CP, except in cases where the FCC is issued by a competent state management agency of countries that have signed a Judicial Assistance Agreement with Vietnam.
• If the FCC for the imported medical device does not specify an expiration date, it must be issued within 36 months from the date of issue.

• Submit the original or a notarized copy of the POA. If submitting a stamped copy by the importing organization or a signed copy by the importing individual, you must present the original for comparison.
• If the POA is issued by a foreign agency, it must meet the following requirements:
  • If the language used in the POA is not English or Vietnamese, it must be translated into Vietnamese.
  • It must be consularized according to the regulations of Decree No. 111/2011/ND-CP, except in cases where the POA is issued by a competent state management agency of countries that have signed a Judicial Assistance Agreement with Vietnam.

8. Medical Device Import License Fee:

9. Application Completion Time:

10. Validity of Medical Device Import License:

11. Required Documents:

• Business registration or business location or company branch
• Product name information
• Product category information
• Company phone number and email

• Authorization letter from the medical device owner to the organization that is the name of the applicable standard declaration
• Certificate of Conformity or Standard Document that the medical device owner declares applicable (Basic Standard)
• ISO 13485:2016 certificate of the manufacturer
• Certificate of Free Circulation valid at the time of application submission for imported medical devices
  

12. Our Services

• Consulting on import license procedures for medical equipment
• Assisting clients in gathering all necessary documents and ensuring their accuracy and completeness.
• Preparing the application dossier in accordance with the regulations of the licensing authority.
• Submitting the application dossier to the relevant authority on behalf of the client.
• Tracking the progress of the application and keeping the client informed.
• Communicating with the licensing authority on behalf of the client.
• Retrieving the import license once it is issued.

13. Reasons to choose Thiên Di's services:

• Experienced and professional experts and staff.
• Regularly updated on new regulations and policies.
• Continuously trained to improve professional skills and work experience.
• Capable of handling high work pressure.
• Always dedicated to self-improvement and professionalism, aiming for absolute customer satisfaction.

13.1. Human Resources

13.2. Additional services:

• Business registration and licensing
• Food safety certification
• Cosmetic registration
• Animal feed and aquatic feed registration
• Intellectual property registration
• Consulting on advertising permits
• Consulting on Free Sale Certificates (CFS)
• Health certificate application
• Contact us today to learn more about our services or to request a free consultation.

 

 

 

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