1. Legal Basis for Importing Medical Equipment
To obtain a medical equipment import license, you must comply with the following laws and decrees:
- Law on Customs 2014
- Decree 36/2016/ND-CP
- Decree 169/2018/ND-CP
2. What is Medical Equipment?
According to Decree No. 36/2016/NĐ-CP and its amendments in Decree No. 169/2016/NĐ-CP, medical equipment is specifically defined as any device, instrument, material, implant, in vitro reagent or calibrator, software, etc. that meets specific requirements:
- 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.
Does not act through pharmacological, immunological, or metabolic mechanisms in or on the human body. If it does, it is only for supportive purposes as specifically regulated.
3. Why is a medical equipment import license required?
Medical equipment is a medical product directly related to human health. Therefore, when importing medical equipment, the importer must apply for a medical equipment import license so that the state agency can control this item entering Vietnam.
4. Forms of medical equipment import license issuance:
- New import license issuance: This applies to medical equipment that is being requested for an import license for the first time or to medical equipment whose import license has expired and has not been renewed.
- Import license renewal: This applies to medical equipment that has already been granted an import license.
- Import license adjustment: This applies to cases where the content of the import license needs to be adjusted while the import license is still valid. It does not include adjusting the validity period of the import license.
- Re-issuance of import license: This applies to cases where the import license is still valid but is lost or damaged.
5. Procedures for Obtaining an Import License for Medical Equipment
To import medical equipment into Vietnam, individuals and organizations must follow these steps:
Step 1: Upon receiving the application for an import license for medical equipment, the Ministry of Health (MOH) will send the applicant a Receipt of Application Form No. 06, as specified in Appendix IV of Decree No. 36/2016/NĐ-CP.
Step 2: If the application is complete and requires no modification, the MOH must assess the application and issue an import license for medical equipment within 15 working days from the date of receipt. If the license is not granted, the MOH must provide a written explanation.
If the application is incomplete, the MOH must notify the applicant within 5 working days from the date of receipt. The notification must specify the missing documents or required amendments.
Step 3: Upon receiving the request for additional information or amendments, the applicant must provide the required documents or make the necessary amendments and submit them to the MOH. The date of receipt of the additional information or amendments will be recorded on the Receipt of Application Form.
If the applicant fails to provide the additional information or amendments within 60 days from the date of the MOH's request, the application will be considered invalid, and the applicant must start the application process again.
Step 4: If no further information or amendments are required, the MOH must issue an import license for medical equipment in accordance with Point b of this section. The import license will be sent to the applicant and the customs agency.
5.1. Classification of Medical Devices for Import Procedures
Upon arrival in Vietnam, all medical devices must first go through the medical device classification procedure. This process categorizes devices into four groups based on the potential risk associated with their technical design and manufacturing:
- 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
Medical masks must be classified by facilities that have been certified by the Ministry of Health as meeting the requirements for medical device classification. Importers who meet the classification requirements can either perform the procedure themselves after declaring their compliance or contact qualified entities for classification. Currently, Thien Di Company provides medical device classification services for customers in need.
As of December 31, 2018, according to Point a, Clause 2, Article 4 of Decree 169/2018/ND-CP, foreign classification results will no longer be recognized under Circular 42/2016/TT-BYT. Therefore, 100% of medical devices must be classified by qualified entities in Vietnam before being imported.
Classification Procedure:
- 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
Time to Receive Results: 1-3 working days.
5.2. Public Announcement of Standards Applied When Importing Medical Equipment of Type A
Dossier for Public Announcement of Standards Applied for Importing Medical Equipment of Type A
The dossier for public announcement of standards applied for medical masks includes the following documents:
- 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.
Requirements for the Dossier for Public Announcement of Standards Applied When Importing 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.
Procedure for Public Announcement of Standards Applied When Importing Medical Equipment
- 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
Required Documents for Customs Clearance:
- 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
Customs Clearance Notes:
- 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:
- Ensure all documents in the import dossier are clearly printed and arranged in the order specified above.
- Separate each document with a divider and include a cover page and a list of documents.
- Completeness for multiple types of equipment: For import dossiers involving multiple types of equipment, provide complete technical documentation describing each type, including catalogs for each type of imported medical device.
- Requirements for Free Circulation Certificates (FCCs):
- 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.
- Requirements for ISO certificates:
Submit the original or a certified copy of the ISO certificate. If submitting a stamped copy by the importing organization or a signed copy by the importing individual, you must provide additional information about the ISO certificate from the issuing organization for comparison.
- Requirements for Power of Attorney (POA):
- 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.
- Catalogs describing functions and technical parameters: Submit the original or a notarized copy of the catalog. If submitting a stamped copy by the importing organization or a signed copy by the importing individual, you must present the original for comparison.
8. Medical Device Import License Fee:
According to Circular No. 278/2016/TT-BTC dated November 14, 2016, the fee for reviewing medical device import license applications is VND 2,000,000 per item per application.
9. Application Completion Time:
The time to complete a medical device import license application is 20 working days, excluding Saturdays, Sundays, and holidays. However, the actual application processing time may be longer than the prescribed time.
10. Validity of Medical Device Import License:
The validity of a medical device import license is valid until the expiration date of the authorization and is valid for a maximum of 01 year from the date of issuance.
11. Required Documents:
Vietnamese Customer Information:
- Business registration or business location or company branch
- Product name information
- Product category information
- Company phone number and email
Documents provided by foreign manufacturers:
- 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:
Enthusiastic and timely customer support in all situations.
Our team consists of:
- 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
Human resources are the key to the success of any business. Therefore, Thien Di always focuses on building and developing a professional, serious, and customer-friendly human resource team - which has been the compass for our success over the past time.
Thien Di provides services for medical equipment import procedures, medical equipment classification services, application for medical equipment import licenses, import licenses for medical equipment, etc. in Vietnam. Currently, we provide this service in most provinces and cities across the country, completing the application and procedures on behalf of clients to submit to state agencies, so clients will not have to spend time doing administrative procedures.
13.2. Additional services:
In addition to consulting on import license procedures for medical equipment, Thiên Di also offers a wide range of other services, including:
- 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.
Contact Info:
THIEN DI TRADING SERVICES COMPANY LIMITED
Address: No. 36 Street A4, Ward 12, Tan Binh District, Ho Chi Minh City
Hotline: 0981317075
Phone: 028.6293 9377
Email: info@luatthiendi.com
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