Circular No. 24/2011/TT-BYT guiding the importation of medical equipment

CIRCULAR

Guidance on the importation of medical equipment

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Pursuant to the Trade Law dated June 14, 2005;

Pursuant to the Law on Product Quality and Commodities dated November 21, 2007;

Pursuant to Decree No. 12/2006/NĐ-CP dated January 23, 2006 detailing the implementation of the Trade Law regarding international trade activities and related agency buying, processing, and transiting goods with foreign countries;

Pursuant to Decree No. 89/2006/NĐ-CP dated August 30, 2006 on product labeling;

CPursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

CPursuant to Decision No. 10/2010/QĐ-TTg dated February 10, 2010 of the Prime Minister on the Certificate of Free Sale for products and goods for export and import;

The Ministry of Health provides guidance on the importation of new medical equipment at 100% for circulation in Vietnam by Vietnamese traders and relevant organizations and individuals (hereinafter referred to as importing units).

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular guides the importation of new medical equipment at 100% for circulation in Vietnam by Vietnamese traders and relevant organizations and individuals (hereinafter referred to as importing units).

Article 2. Interpretation of Terms

Medical equipment includes various types of devices, tools, materials, chemicals, including necessary software, used individually or in combination to serve humans for the purpose of:

a) Preventing, detecting, diagnosing, treating, alleviating diseases, or compensating for injuries;

b) Examining, replacing, modifying, supporting surgical procedures during medical examinations and treatments;

c) Support or maintenance of life;

d) Control of conception;

d) Sterilization in healthcare (excluding insecticides, bactericides used in household and healthcare settings);

e) Specialized transportation serving healthcare activities;

Chapter II

CONDITIONS, AUTHORITY, PROCEDURES FOR ISSUING IMPORT LICENSES FOR MEDICAL EQUIPMENT

Article 3. Conditions for Importing Units of Medical Equipment

1. Legal conditions:

Having a business registration certificate or investment certificate registering the scope of business as trading and importing medical equipment.

2. Personnel conditions:

a) The technical responsible staff must meet one of the following requirements:

Holding a bachelor's degree in biomedical electronics or biophysical engineering or holding a bachelor's degree in engineering, medicine, pharmacy, and a specialized training certificate in medical equipment issued by legitimate training institutions on medical equipment technology or an equivalent certificate issued abroad with appropriate training fields corresponding to the medical equipment proposed for import by the unit.

For staff holding a bachelor's degree in engineering, medicine, pharmacy, and having at least three years of direct work experience in medical equipment technology or management in legitimate healthcare facilities confirmed by the head of their workplace, they do not need to have a specialized training certificate in medical equipment.

b) Having technical staff capable of guiding installation, warranty, and maintenance of medical equipment related to the equipment being imported.

3. Physical Conditions:

a) Having premises and warehouses to properly store medical equipment, ensuring that the equipment is stored under suitable conditions and protected from the effects of light, temperature, humidity, and other factors.

b) Having fire prevention and explosion protection equipment and ensuring environmental safety according to legal regulations.

4. Labels on Imported Medical Equipment:

Implementing the provisions of Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government on product labeling and Circular No. 09/2007/TT-BKHCN dated April 6, 2007 of the Ministry of Science and Technology guiding the implementation of certain articles of Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government on product labeling and other related regulations.

Article 4. Scope of Import Permit for Medical Equipment

1. An importing entity shall apply to the Ministry of Health for an import permit when importing medical equipment listed in Appendix 1 attached hereto.

2. For medical equipment not listed in Appendix 1 but which applies new diagnostic or treatment methods and is being imported into Vietnam for the first time, an application for an import permit from the Ministry of Health must be submitted.

3. An importing entity does not need to apply for an import permit for medical equipment not listed in Appendix 1, except in cases stipulated in Clause 2 of Article 4 of this Circular, but must still comply with the provisions set forth in Points b and c of Clause 1 of Article 5 of this Circular.

Article 5. Documents and Procedures for Applying for an Import Permit for Medical Equipment

1. The application dossier for an import permit for medical equipment (one set) includes:

a) An application form for an import permit signed and confirmed by the person responsible for the entity before the law, stamped, or by a legally authorized representative according to the model prescribed in Appendix 2 attached hereto.

b) Legal documents:

Business registration certificate or investment certificate (certified copy).

c) Documents on imported medical equipment:

- A valid international quality management standard certification ISO 13485 or ISO 9001 and its validity period issued by the manufacturer or the producing country for imported medical equipment.

- A free sale certificate for imported medical equipment products (CFS - Certificate of Free Sale) in the producing country, or a permission to circulate certificate from the FDA-US organization, or a European Quality Standard Certification (CE Mark Certificate) that is valid and within its validity period (original or certified copy in Vietnam or legalization certification at diplomatic representation or the Embassy of Vietnam in the producing country). Minimum requirements for the free sale certificate for imported medical equipment products are specified in Appendix 3 attached hereto. - A power of attorney from the manufacturer or legal distributor authorizing the importing entity to import and distribute medical equipment products in Vietnam, which is valid and within its validity period (original or certified copy in Vietnam or legalization certification at diplomatic representation or the Embassy of Vietnam in the producing country).

- Product description (Catalogue) of imported medical equipment (original or certified copy confirmed by the importing entity).

- Technical documentation describing imported medical equipment in Vietnamese according to Appendix 4 attached hereto.

2. The application dossier for imported medical equipment must be arranged in the order prescribed in Appendix 5 attached hereto and must be bound into a set for each type of equipment, with the cover page clearly stating the name of the importing entity and contact information. If a type of medical equipment is imported from multiple manufacturers or countries, products from each manufacturer or country must have complete documentation and be arranged in accordance with the order required in the application letter for the import permit of the entity. 3. Procedure for applying for an import permit for medical equipment:

a) For entities importing medical equipment for the first time: The importing entity shall prepare the application dossier for an import permit in accordance with the guidance provided in Clauses 1 and 2 of Article 5 of this Circular. The dossier shall be sent to the Ministry of Health (Department of Medical Equipment and Construction) at address No. 138A, Giang Vo, Ba Dinh, Hanoi. - For medical equipment not listed in Appendix 1 but which applies new diagnostic or treatment methods and is being imported into Vietnam for the first time: In addition to the conditions, documents, and procedures for applying for an import permit as prescribed in Clause 1, Article 5, the imported medical equipment must have clinical trial results and be reviewed and approved by the Scientific and Technological Council of the Ministry of Health before it can be imported.

- For certain special medical equipment accepted and recommended for use in other countries by international organizations, the Ministry of Health will consider waiving clinical trials based on the conclusion of the Scientific and Technological Council of the Ministry of Health.

ab) For entities importing medical equipment from the second time onwards (from the date this Circular takes effect):

- The importing entity does not need to submit the legal documents of the entity as prescribed in Point b of Clause 1 of Article 5 of this Circular.

- If importing medical equipment of the same type, brand, and producing country as previously approved by the Ministry of Health for importation, there is no need to submit the product feature description (Catalogue) or technical documentation describing imported medical equipment as prescribed in Point c of Clause 1 of Article 5 of this Circular.

- The entity must submit a copy of the previous import permit issued by the Ministry of Health.

- The importing unit is not required to submit the legal documentation of the entity as specified in Point b, Clause 1, Article 5 of this Circular.

- If importing medical equipment of the same type, brand, and country of manufacture that have previously been permitted for import by the Ministry of Health, it is not necessary to submit the product feature description (Catalogue),technical documentation describing the imported medical equipment as specified in Point c, Clause 1, Article 5 of this Circular.

- The unit must submit a copy of the previous import permit issued by the Ministry of Health.

Article 6. Issuance of Import Permits for Medical Equipment

1. The Ministry of Health shall examine and issue import permits for medical equipment listed in Appendix 1 within fifteen working days from the date of receipt of complete and valid documents. In cases where an import permit is not issued, the Ministry of Health (Department of Medical Equipment and Health Works) shall provide a written response to the importing entity and clearly state the reasons.

2. Validity period of import permits: An import permit is valid for one year from the date of issuance.

3. Fees for issuing import permits: The importing entity must pay the import fee according to current regulations and as stipulated in Decision No. 44/2005/QD-BTC dated July 12, 2005 and Decision No. 59/2008/QD-BTC dated July 21, 2008 of the Ministry of Finance regarding the collection, payment, management, and use of fees for business trade activities with conditions in the health sector, standardization assessment fees, and occupational practice certification fees.

Chapter III

HANDLING VIOLATIONS

Article 7. Handling Violations

1. In cases where the importing entity engages in fraudulent behavior or擅自修改或伪造文件、资料、法律文件，无论是来自越南还是外国的官方机构；或者使用假印章或伪造进口单位及其相关机构在医疗器械进口文件上的签名或印章，则卫生部（医疗设备和卫生工程司）将向该单位发出警告信，并暂停受理和审查其进口医疗器械的申请，具体如下：

a) Suspend acceptance and review of import application documents for three months for the first violation;

b) Suspend acceptance and review of import application documents for six to twelve months for a second violation within twelve months;

c) Depending on the severity of the violation, the Ministry of Health (Department of Medical Equipment and Health Works) will issue a notice to the importing entity and suspend acceptance and review of import application documents.

In addition to the above measures, the Ministry of Health (Department of Medical Equipment and Health Works) will publicly disclose the violations of the importing entity on the Ministry's electronic portal; notify the Inspection Agency, Customs Authority, and other competent authorities to consider and handle the matter according to the law.

2. Individuals or organizations that violate the law will be subject to administrative disciplinary action, administrative fines, or criminal prosecution depending on the nature and severity of the violation; if damage is caused, they must compensate according to the law.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 8. Responsibilities for Implementation

1. The Department of Medical Equipment and Health Works, as the permanent unit of the Ministry of Health, is responsible for compiling and submitting import application documents to the Advisory Council for Import Permitting of Medical Equipment - Ministry of Health for examination.

2. The Inspectorate of the Ministry of Health is responsible for coordinating with relevant Departments and Bureaus under the Ministry of Health to conduct inspections and audits nationwide on business operations and imports of medical equipment.

3. Provincial Health Departments are responsible for conducting inspections and audits on business operations and imports of medical equipment at the local level.

4. Importing entities are responsible for strictly adhering to legal regulations and are liable for the type, quantity, and quality of imported goods, and have the responsibility to report, recall, and warn about unsafe products that are detrimental to users and the community.

5. Importing entities must submit an annual report (before January 30 each year) on the situation of imported medical equipment (name of equipment, quantity, type, manufacturer, country of manufacture, user unit, import value) to the Ministry of Health (Department of Medical Equipment and Health Works) in accordance with Appendix 6 attached to this Circular.

After the annual reporting deadline, the Advisory Council for Import Permitting of Medical Equipment - Ministry of Health will base its examination and approval of subsequent import permits on the reports submitted by the importing entities.In cases where there are changes in the name, transaction address, leadership personnel, technical staff, import-related staff, etc., of the importing entity, the entity must report these changes in writing to the Ministry of Health (Department of Medical Equipment and Health Works) after the change occurs.

This Circular takes effect from August 15, 2011.

Article 9. Effective Date

Abolish the provisions on the importation of medical equipment set forth in Circular No. 08/2006/TT-BYT dated June 13, 2006 of the Ministry of Health guiding the importation of vaccines, medical reagents; chemicals, insecticides, bactericides used in household and medical fields, and medical equipment, and Circular No. 09/2006/TT-BYT dated July 11, 2006 guiding amendments and supplements to Section IV and Appendix 9 of Circular No. 08/2006/TT-BYT dated June 13, 2006 of the Ministry of Health guiding the importation of vaccines, medical reagents; chemicals, insecticides, bactericides used in household and medical fields, and medical equipment.

During implementation, if there are any difficulties, please promptly report them to the Ministry of Health (Department of Medical Equipment and Health Works) for consideration and resolution./.

During implementation, if there are any difficulties, they should be promptly reported to the Ministry of Health (Department of Medical Equipment and Health Works) for consideration and resolution./.