Circular No. 30/2015/TT-BYT on the importation of medical equipment

CIRCULAR

Regulations on the importation of medical equipment

Pursuant to the Commercial Law dated June 14, 2005;

Based on Decree No. 187/2013/NĐ-CP dated November 20, 2013 of the Government detailing the implementation of the Law on Trade regarding international trade activities and foreign agency buying, selling, processing, and transiting goods.

Based on Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, authorities, and organizational structure of the Ministry of Health The Minister of Health issues this Circular to regulate the importation of medical equipment.;

On the proposal of the Director of the Department of Medical Equipment and Infrastructure;

1. This Circular regulates the authority, documents, and procedures for issuing new import permits for medical equipment (hereinafter referred to as import permit) that are entirely within the categories specified in Appendix I attached hereto.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

2. The importation of medical equipment under the form of aid (including medical equipment with over 80% quality), temporary import for re-export, temporary export for re-import, cargo transfer, movable medical equipment, and medical equipment serving the needs of individuals with diplomatic status and personal luggage shall be carried out in accordance with Decree No. 187/2013/NĐ-CP dated November 20, 2013 of the Government detailing the implementation of the Law on Trade regarding international trade activities and foreign agency buying, selling, processing, and transiting goods, and the guidance of the Ministry of Industry and Trade.

Medical equipment

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. includes various types of devices, tools, materials, in vitro diagnostic chemicals, software used individually or in combination according to the owner's instructions to serve humans for one or more of the following purposes: a) Diagnosis, prevention, monitoring, treatment, and alleviation of diseases or compensation for injuries;

d) Sterilization of medical equipment (excluding insecticides, bactericides used in household and medical fields);

b) Examination, replacement, adjustment, or support for anatomical and physiological processes;

c) Support or maintenance of life;

d) Control of conception;

e) For use in medical equipment;

g) Special transportation for medical activities.

In vitro diagnostic chemicals

2. include test reagents, diagnostic chemicals, washing solutions used for medical equipment (excluding in vitro diagnostic biological products). Manufacturer is the entity responsible for designing, producing, assembling, packaging, and labeling medical equipment before it is supplied.

Distributor is any individual or organization abroad authorized by the owner to distribute medical equipment.

4. Owner of medical equipment (hereinafter referred to as the owner) is any individual or organization directly implementing or allowing other individuals or organizations to use their name to supply medical equipment under their own name or any trademark, design, trade name, or other name or code owned or controlled by them and is responsible for the design, production, assembly, labeling, packaging, or maintenance and repair of medical equipment or determining its purpose of use.

5. Article 3. Principles for Issuing Import Permits 1. The issuance of import permits for medical equipment only applies to medical equipment imported within the categories listed in Appendix I attached hereto.

2. Medical equipment not included in the categories specified in Appendix I attached hereto may be imported without an import permit but must still ensure documentation for traceability of origin, place of manufacture, and management of medical equipment quality in accordance with the law.

AUTHORITY, DOCUMENTS, AND PROCEDURES FOR ISSUING NEW, EXTENDING, AMENDING, REISSUING, AND REVOKING IMPORT PERMITS FOR MEDICAL EQUIPMENT

Authority for issuing new, extending, amending, reissuing, and revoking import permits for medical equipment

Chapter II

The Minister of Health decides on the issuance of new, extension, amendment, reissuance, and revocation of import permits for medical equipment.

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Article 4. Competent authority for issuing, renewing, amending, reissuing, and revoking import permits for medical equipment

The Minister of Health shall decide on issuing, renewing, amending, reissuing, and revoking import permits for medical equipment.

Article 5. Forms of Issuing Import Permits for Medical Devices

1. The issuance of new import permits for medical devices shall apply in cases where medical devices are being requested to obtain an import permit for the first time, or where the import permit has expired without renewal in accordance with Clause 1, Article 13 of this Circular.

2. The extension of import permits for medical devices shall apply in cases where medical devices have already been issued an import permit.

3. The amendment of the contents of import permits shall apply to cases where the import permit remains valid but there is a change in the content of the import permit. The validity period of the import permit shall not be amended.

4. The reissuance of import permits for medical devices shall apply in cases where the import permit remains valid but has been lost or damaged.

Article 6. Documents for Requesting New Import Permits for Medical Devices

1. A request for issuing a new import permit from organizations or individuals requesting a new import permit in accordance with Form No. 01 stipulated in Appendix II promulgated together with this Circular.

2. A free circulation certificate for the type of imported medical device that remains valid at the time of submitting the application.

3. An international quality management system certification ISO 13485 or ISO 9001 (hereinafter referred to as the ISO certificate) of the manufacturer that remains valid at the time of submitting the application.

4. A power of attorney from the owner of the medical device for organizations or individuals to carry out the importation of medical devices in accordance with the form stipulated in Appendix III promulgated together with this Circular (hereinafter referred to as the power of attorney) that remains valid at the time of submitting the application.

5. Technical documentation describing the type of imported medical device in Vietnamese in accordance with the form stipulated in Appendix IV promulgated together with this Circular.

6. A catalog describing the functions and technical specifications of the type of imported medical device.

7. Clinical evaluation documents and user manuals provided by the owner or manufacturer for medical devices listed under Item 49 of Appendix I promulgated together with this Circular.

8. A report on the results of importing medical devices up to the time of submitting the application for a new import permit for medical devices in cases where the import permit has expired without renewal in accordance with Clause 2, Article 5 of this Circular. The import results report shall be carried out in accordance with the form stipulated in Appendix VI promulgated together with this Circular.

Article 7. Documents for Requesting Extension of Import Permits for Medical Devices

1. A request for extending an import permit from organizations or individuals requesting an extension of an import permit in accordance with Form 02 stipulated in Appendix II promulgated together with this Circular.

2. A free circulation certificate for the type of imported medical device that remains valid at the time of submitting the application.

3. An ISO certificate of the medical device manufacturer that remains valid at the time of submitting the application.

4. A power of attorney that remains valid at the time of submitting the application.

5. A report on the results of importing medical devices up to the time of submitting the application for extending the import permit for medical devices in accordance with the form stipulated in Appendix VI promulgated together with this Circular.

Article 8. Documents for requesting adjustment of import permit of medical equipment

1. Documents for requesting adjustment of manufacturer and country of medical equipment production:

a) A request document for adjusting the import permit of organizations or individuals importing medical equipment according to Model No. 03 prescribed in Appendix II issued together with this Circular;

b) Free Circulation Certificate for types of medical equipment with additional content on adjustment of manufacturer and country of medical equipment production still valid at the time of submitting the documents;

c) ISO certification of the manufacturer and country of medical equipment production still valid at the time of submitting the documents.

2. Documents for requesting adjustment of name of organization or individual importing or name of imported medical equipment:

a) A request document for adjusting the import permit of organizations or individuals importing medical equipment according to Model No. 03 prescribed in Appendix II issued together with this Circular;

b) Technical documentation describing the type of imported medical equipment in Vietnamese according to the model prescribed in Appendix IV issued together with this Circular and Catalogue describing functions and technical specifications of the type of imported medical equipment in case of requesting adjustment of the name of imported medical equipment.

Article 9. Documents for requesting reissue of import permit of medical equipment

Documents for requesting reissue of import permit in cases of loss or damage: A request document for reissuing the import permit of organizations or individuals importing medical equipment according to Model No. 04 prescribed in Appendix II issued together with this Circular.

Article 10. Requirements for documents in applications for new issuance, reissuance, extension, and adjustment of import permits for medical equipment

1. Applications for new issuance, reissuance, extension, and adjustment of import permits (hereinafter referred to as import application documents) shall be made into one set, including:

a) Documents in the import application shall be clearly printed, arranged in the order prescribed in Articles 6, 7, 8, and 9 of this Circular, and separated between each document, with a cover page and list of documents;

b) For applications involving multiple types of medical equipment, complete technical documentation describing each type and catalogues of imported medical equipment must be provided.

2. Requirements for Free Circulation Certificates in import application documents:

a) Submit original or certified copy or stamped copy by the organization applying for import or signed copy by the individual applying for import. In case of submitting a stamped copy of the Free Circulation Certificate by the organization applying for import or signed copy by the individual applying for import, the original must be presented for verification;

b) If the Free Circulation Certificate is issued by a foreign authority, before submission as prescribed in Point a of this Clause, it must meet the following requirements:

- If the language used in the Free Circulation Certificate is not English or Vietnamese, it must be translated into Vietnamese;

- It must be legalized consularly in accordance with the provisions of Decree No. 111/2011/ND-CP dated December 2, 2011 of the Government on consular certification and legalization (hereinafter referred to as Decree No. 111/2011/ND-CP), except where the Free Circulation Certificate is issued by a competent state management agency of countries that have concluded Mutual Legal Assistance Agreements with Vietnam.

c) If the Free Circulation Certificate for types of imported medical equipment does not clearly indicate the expiration date, it must be issued within 24 months from the date of issue.

3. Requirements for ISO certificates in import application documents:

Submit original or certified copy or stamped copy by the organization applying for import or signed copy by the individual applying for import. In case of submitting a stamped copy by the organization applying for import or signed copy by the individual applying for import, supplementary information related to the ISO certificate issued by the certifying organization must be provided for verification.

4. Requirements for power of attorney:

a) Submit original or notarized copy or stamped copy by the organization applying for import or signed copy by the individual applying for import. In case of submitting a stamped copy of the Free Circulation Certificate by the organization applying for import or signed copy by the individual applying for import, the original must be presented for verification;

b) If the power of attorney is issued by a foreign authority, before submission as prescribed in Point a of this Clause, it must meet the following requirements:

- If the language used in the power of attorney is not English or Vietnamese, it must be translated into Vietnamese;

- It must be legalized consularly in accordance with the provisions of Decree No. 111/2011/ND-CP, except where the Free Circulation Certificate is issued by a competent state management agency of countries that have concluded Mutual Legal Assistance Agreements with Vietnam.

5. For Catalogue describing functions and technical specifications of types of imported medical equipment:

Submit original or notarized copy or stamped copy by the organization applying for import or signed copy by the individual applying for import. In case of submitting a stamped copy by the organization applying for import or signed copy by the individual applying for import, the original must be presented for verification.

Article 11. Acceptance of applications for new issuance, extension, adjustment, and reissuance of medical equipment import permits

1. Organizations and individuals applying for new issuance, extension, adjustment, and reissuance of medical equipment import permits (hereinafter referred to as importing units) shall submit import files to the Ministry of Health (Department of Medical Equipment and Health Works).

2. After accepting the import file, the Ministry of Health shall issue to the importing unit a Receipt for Application File, the date of receipt of the application for the import permit shall be calculated from the date recorded on the Ministry of Health's receipt stamp.

Article 12. Procedures for issuing new medical equipment import permits

1. Within five working days from the date recorded on the Receipt for Application File, the Ministry of Health shall be responsible for examining the completeness and validity of the application file for new issuance of medical equipment import permits.

2. In case the application file is complete and valid, the Ministry of Health shall organize a meeting of the Advisory Council for Issuing Medical Equipment Import Permits of the Ministry of Health (hereinafter referred to as the Advisory Council) to examine and provide opinions on the application file for new issuance of medical equipment import permits within ten working days from the date recorded on the Receipt for Application File:

a) In case the Advisory Council does not require modification or supplementation of the import file and agrees to issue the import permit, the Ministry of Health must proceed with the issuance of the new import permit within ten working days from the date of the Advisory Council meeting minutes, the date of the Advisory Council meeting minutes is considered the date of the meeting.

Based on the Advisory Council meeting minutes, the Minister of Health shall examine and decide to issue the medical equipment import permit. In case of refusal, there shall be a written response stating the reasons.

b) In case the Advisory Council requires modification or supplementation of the file:

- Within five working days from the date of the Advisory Council meeting minutes, the Ministry of Health must issue a written notice to the importing unit to modify or supplement the import file. The notice must specify which documents need to be supplemented and which contents need to be modified. The notification of completion of the file can only be carried out once, except in cases where the contents that the Ministry of Health has requested to be completed but the importing unit has not completed or completed incorrectly according to the requirements of the Ministry of Health;

- Upon receiving the written request for modification or supplementation of the import file, the importing unit must modify or supplement according to the contents recorded in the notice and send it back to the Ministry of Health. The date of receipt of the supplementary and modified file is recorded on the Ministry of Health's receipt stamp for incoming documents and shall be processed according to the provisions of Clause 1 and Point a Clause 2 of this Article.

- In case the importing unit has modified or supplemented the import file but not in accordance with the requirements, the Ministry of Health will notify the importing unit to continue completing the import file in accordance with the provisions of Clauses 1 and 2 of this Article;

- In case there is a request for modification or supplementation of the import file, but after sixty (60) days from the date the Ministry of Health issues a written notice requesting modification or supplementation of the import file, the importing unit does not implement the request, the Ministry of Health will refuse to continue examining the import file.

3. In case the file is incomplete or invalid:

a) Within ten working days from the date recorded on the Receipt for Application File, the Ministry of Health must issue a written notice to the importing unit to modify or supplement the import file. The notice must specifically state which documents need to be supplemented and which contents need to be modified. The notification of completion of the file can only be carried out once, except in cases where the contents that the Ministry of Health has requested to be completed but the importing unit has not completed or completed incorrectly according to the requirements of the Ministry of Health;

b) Upon receiving the written request for modification or supplementation of the import file, the importing unit must modify or supplement according to the contents recorded in the notice and send it back to the Ministry of Health. The date of receipt of the supplementary and modified file is recorded on the Ministry of Health's receipt stamp for incoming documents;

c) In case the importing unit has modified or supplemented the import file but not in accordance with the requirements, the Ministry of Health will notify the importing unit to continue completing the import file in accordance with the provisions of Point a Clause of this Article;

d) If there is no longer a requirement for modification or supplementation of the import file, the Ministry of Health must proceed with the issuance of the new import permit in accordance with the provisions of Point a Clause 2 of this Article.

4. In case there is a request for modification or supplementation of the import file, but after sixty (60) days from the date the Ministry of Health issues a written notice requesting modification or supplementation of the import file, the importing unit does not implement the request, the Ministry of Health will refuse to continue examining the import file.

Article 13. Procedures for extending and adjusting import permits

1. Time limit for submitting applications for extending and adjusting import permits:

a) Applications for extending and adjusting import permits must be submitted to the Ministry of Health at least 15 working days before the import permit expires. The submission date is calculated from the date recorded on the Application Receipt Form;

b) After the time limit specified in Point a of this Clause, if the importing entity wishes to continue obtaining an import permit, it must apply for a new import permit.

2. Within five working days from the date recorded on the Application Receipt Form, the Ministry of Health shall be responsible for examining the completeness and validity of the application for extending and adjusting the import permit.

3. In case the application is complete and valid, the Ministry of Health shall be responsible for extending and adjusting the import permit within ten working days from the date recorded on the Application Receipt Form.

4. In case the application is incomplete or invalid: Implement the provisions set out in Clause 3, Article 11 of this Circular.

5. In case there is a request to amend or supplement the import application but after sixty (60) days from the date the Ministry of Health issues a notification requesting amendments or supplements to the import application, the importing entity does not comply with the request, the Ministry of Health will refuse to continue reviewing the import application.

Article 14. Procedures for reissuing import permits

Within five working days from the date recorded on the Application Receipt Form, the Ministry of Health shall be responsible for reissuing the import permit.

Article 15. Advisory Council for Issuing Import Permits for Medical Equipment of the Ministry of Health

1. The Advisory Council for Issuing Import Permits for Medical Equipment of the Ministry of Health is established by the Minister of Health's decision and has the following responsibilities:

a) To advise the Minister of Health on technical issues related to imported medical equipment;

b) To review and provide opinions on applications for issuing import permits for medical equipment before presenting them to the Minister of Health for decision.

2. The Secretariat assisting the Advisory Council includes members who are specialists from the Department of Medical Equipment and Health Facilities.

Article 16. Validity of Import Permits for Medical Equipment

The validity period of the import permit for medical equipment is effective until the authorization period and has a maximum duration of one year from the date of issuance.

Article 17. Fees for Issuing, Extending, Adjusting, and Reissuing Import Permits for Medical Equipment

The importing entity of medical equipment is responsible for paying fees for issuing, extending, adjusting, and reissuing import permits at the Ministry of Health according to the laws on fees and charges.

Article 18. Revocation of Import Permits for Medical Equipment

1. Cases subject to revocation of import permits for medical equipment

a) The importing entity falsifies the application for issuing an import permit for medical equipment;

b) Organizations or individuals alter the content of the import permit for medical equipment by erasing or tampering;

c) The importing entity of medical equipment ceases operations or no longer holds authorization from the owner or manufacturer of medical equipment without transferring import rights to a replacement organization;

d) Medical equipment circulating in the market has defects that adversely affect user health and cannot be corrected;

đ) The import permit for medical equipment was issued beyond authority, or did not follow the procedures stipulated in this Circular;

e) Medical equipment has exceeded its circulation period as announced by the manufacturer or owner of the medical equipment or the competent authority.

2. Procedures for Revoking Import Permits for Medical Equipment

a) During inspection and audit, if violations are discovered under any of the cases specified in Clause 1 of this Article, the inspecting or auditing entity must prepare a record and send it to the Ministry of Health;

b) Within five working days from the date of receiving the record specified in Point a of this Clause, the Ministry of Health shall examine and decide on the revocation of the import permit for medical equipment. The decision to revoke the import permit for medical equipment shall be publicly posted on the Ministry of Health's electronic portal and simultaneously sent to customs authorities and organizations or individuals responsible for imports.

3. After the decision to revoke the import permit for medical equipment is made, the importing entity is responsible for recalling the medical equipment listed in the revocation decision and may not continue to import such medical equipment.

Chapter III

IMPLEMENTATION PROVISIONS

Article 19. Effective Date

1. This Circular takes effect from the date of      month      year 2015.

2. Circular No. 24/2011/TT-BYT dated June 21, 2011, guiding the importation of medical equipment issued by the Minister of Health becomes ineffective from the date this Circular takes effect.

Article 20. Transitional Provisions

1. In case the referenced documents in this Circular are amended, supplemented, replaced, or abolished, they shall be applied according to the amended, supplemented, replaced, or abolished documents.

2. Import permits for medical equipment already issued under Circular No. 24/2011/TT-BYT dated June 21, 2011, guiding the importation of medical equipment remain valid until their expiration date as stated on the permit.

3. For medical equipment not included in the list specified in Appendix I attached to this Circular, which has been granted import permits, they can be imported without an import permit from the date this Circular takes effect.

Article 21. Responsibility for Implementation

The Director of the Department of Medical Equipment and Health Facilities, the Head of the Ministry's Office, the Inspector General of the Ministry, Heads of Departments, Directors of Bureaus, and General Directors of the Bureaus and General Directorates under the Ministry of Health; Provincial Health Service Directors and relevant agencies, organizations, and individuals are responsible for implementing this Circular.

Any difficulties or obstacles encountered during implementation should be reported to the Ministry of Health (Department of Medical Equipment and Health Facilities) for consideration and resolution./.