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Service import permit application by the Ministry of Health
Indochinapost supplies service of import license application by the Ministry of Health quickly, simply and affordably.
Related documents:
– Commercial Law dated 14/6/2005;
– Law on product quality goods 21/11/2007;
– Decree No. 12/2006 / ND-CP dated 23/01/2006 detailing the implementation of the Commercial Law regarding goods trading activities and the activities of international purchasing agent, processing and transit with foreign countries;
– Decree No. 89/2006 / ND-CP dated 30/8/2006 on goods labeling;
– Decree No. 188/2007 / ND-CP dated 27/12/2007 defining the functions, tasks, powers and organizational structure of the Ministry of Health;
– Decision 10/2010 / QD-TTg dated 10/02/2010 of the Prime Minister specified certificate of free sale for the product, exports and imports;
– Circular 24/2011 / TT-BYT guiding the import of Health facilities
Conditions for the importers of medical equipments to get import permit:
1. Legal conditions:
Having the certificate of business registration or certificate of registration of investment which is the range of business sectors, import medical equipment.
2. Conditions of personnel:
a) Personnel responsible technician must meet one of the following requirements:
Having a college degree specialized biomedical electronics, biomedical physics or have a university degree in engineering, medical college degree, pharmacy and specialized training certificate medical equipment by the base legal training technical medical equipment or certificate issued by foreign equivalent with appropriate training field with medical equipment units imported proposal.
For those workers with a university degree in engineering, with university medical and pharmaceutical and spent time working directly for technical medical devices or as the management of medical equipment in the legitimate medical facility for 3 years or more have confirmation from the heads of working units is not required to have specialized training certificate of medical equipment.
b) Officials and technical staff qualified installation manual, warranty, maintenance of medical equipment and related equipment which imported units.
3. Conditions facilities:
a) There are grounds, well-preserved treasures to medical equipment, ensure the medical equipment is stored with appropriate conditions, be protected from the influence of the elements: light temperature, humidity and other conditions.
b) Means of fire prevention to ensure safety and sanitation as prescribed by law.
4. Label of imported medical equipment:
Follow the provisions in Decree No. 89/2006 / ND-CP dated 30/8/2006 of the Government on goods labels and Circular No. 09/2007 / TT-BKHCN 06/4/2007 of Ministry of Science technology and guiding a number of articles of Decree 89/2006 / ND-CP dated 30/8/2006 of the Government on goods labeling and other relevant regulations.
Dossiers of application for import permit of medical equipment (01) includes:
a) An application for import permit by the head responsible before the law to certify and stamp or authorized person lawfully in the form prescribed in Appendix 2 attached to this Circular.
b) Legal documents:
Certificate of business registration or investment certificate (certified copy).
c) Records of medical equipment import:
– Certificate management standards ISO 13485 international quality or valid ISO 9001 and the remaining term of its validity, producer of medical equipment imports.
– Certificate of free sale for the medical equipment imported (CFS – Certificate of Free Sale) in water production or circulation permit certification of FDA-American organizations, or certificates achieved European quality standards (CE Mark Certificate) invalid and valid duration.
– The written authorization of the manufacturer or distributor to legitimate the importer is allowed to import and distribute products of medical equipment in Vietnam invalid and valid duration (original or copy certified in Vietnam or legalization certificate at the diplomatic missions or embassies of Vietnam in producing countries).
– A description of the product (Catalogue) medical equipment imported (originals or copies certified by the importer).
– Technical documents Product description medical equipment imported by Vietnamese.
The types of equipment must have import permit of medical equipment (Appendix 1 Circular 30/2015 / TT-BYT):
- Equipment Diagnostics: X-rays, magnetic resonance systems, ultrasound. Endoscopes, refractometer, automatic cornea, measuring osteoporosis. Electrophysiological measurements (EEG, ECG, electric motor), electrical measurement retina, the osteoporosis. CT scanner, heart rate monitors, hematology analysis. Coagulation gauges, test, Elisa cell extraction. Identification of the bacterial virus, the immune analysis, ….
- The types of treatment equipment: X-ray, endoscopic surgery, radiation therapy, patient monitoring. Infusion pump, electric injection, scalpel, surgical microscopes, artificial heart lung machine. Prostate surgery, cardiopulmonary bypass, machine ventilation cryosurgery, surgery. Anesthesia, ventilation, oxygen chamber, lithotripsy, dialysis, cardiac, cranial nerve …
