Business Club May 3 hearing Brazil is the largest medical device market in Latin America. In 2010, the Brazilian medical device market had a sales volume of US$3.6 billion. In 2011, it quickly exceeded US$4 billion and became the eighth largest medical device market in the world. The development speed is very alarming.
The introductory industry report released last year by the American Medical Device Industry Association shows that Brazil has a relatively complete medical device industry, with the exception of some high-end electronic imaging diagnostic equipment (such as CT machines, MRI machines, PET machines, etc.) that cannot be independently produced. Most medical devices can be produced in Brazil. There are more than 500 medical device manufacturers in Brazil. The domestic sales rate of medical device products is as high as 92%, which is basically an "inward-looking industry." At present, Brazilian state-owned hospitals account for about 58% of the total number of hospitals in the country. They are the main users of medical devices, and private hospitals account for about 42%, which is quite similar to India.
Huge trade deficit In 2011, Brazil exported more than 500 million U.S. dollars worth of medical device products; in the same year, its medical device imports reached 2.7 billion U.S. dollars. Orthopedic devices, implantable prostheses and related materials, and various diagnostic instruments rank in the top three positions in Brazilian medical device import products. At present, 54 important medical equipment and equipment products such as high-end electronic imaging diagnostic products, hyperbaric oxygen chambers, and fiberscopes are still imported from developed countries in Brazil. This is the main reason for the huge trade deficit in Brazil's medical device trade. Of the medical device products imported from Brazil, 68% are from Europe and the United States, while China's medical devices account for only a small share, and are mostly low-end products such as disposable medical devices (such as syringes and medical catheters).
Although the export volume of medical devices in Brazil is relatively low, the export destination market is as many as 108 countries or regions. In addition to developed countries such as the United States, Germany, Britain, and France, Brazilian medical devices are also exported to third world countries such as Ukraine, Moldavia, Argentina, and Mexico.
Execution of U.S. Standards Brazilian implementation of U.S.-promulgated medical device classification and quality standards is undoubtedly a good thing for U.S. manufacturers because their products can be listed in Brazil as long as they are approved by the FDA, but the third world countries The entry of medical device products into Brazil is not easy.
In accordance with the Brazilian government's regulations, to conduct any product involving the human body (such as pharmaceuticals, medical devices, cosmetics, etc.), the exporter must submit a written application to the Brazilian Ministry of Health in advance. The application form includes: company name, product name, product performance, and Use, FDA approval number, product photo or image, material used in product introduction, usage guide, product label, sterilization index, quality control data, clinical data (public information), product manual, etc.
Higher registration fees Brazil has higher registration fees for medicines, medical devices, and beauty products. In 2010, the annual registration fee for medicines and medical equipment products in Brazil was 20,000 riyals (Brazilian currency), and the registration fee for cosmetics was as high as 30,000 rials.
Zero tariffs on some products For certain medical device products that rely mainly on imports, Brazil implements a zero tariff policy. Specific products include: 1. Isotope and radioactive medical materials; 2. Gut and other surgical sutures, etc. 3. Blood type reagents; 4. Radiology examination reagents; 5. Dental filling materials; 6. X-ray film and similar products, etc. 7. Medical microbiological culture medium; 8. Medical diagnostic test paper; 9. All kinds of medical plastic products, such as 10. Urology flush plastic basin; 11. Disposable surgical gloves (latex gloves, etc.) 12. Syringe products (including disposable or reusable syringe products); 13. Hemodialysis equipment;14. Various endoscopes and related accessories, etc. Prostate surgical instruments, etc. 16. A variety of ophthalmic equipment products; 17. Implantable prosthetic products (such as heart valves and artificial corneas); 18. Defibrillators and other products.
Still, high-speed growth Western market analysts believe that based on the rapid economic growth in Brazil, the total size of the Brazilian medical device market in 2016 will reach more than US$8 billion. Cardiovascular disease treatment devices, especially interventional and minimally invasive devices (such as various implantable stents, intravascular balloon inflators, cardiac pacemakers, atrial defibrillators, etc.), burn or trauma treatment devices, and various household appliances Medical device products (such as electronic sphygmomanometers, electronic glucometers, weight scales, hearing aids, massage devices, etc.) will be the best-selling products on the Brazilian medical device market in the next 10 years.
In addition, in the next few years, as the Brazilian government expands its investment in state-owned hospitals, these hospitals will continue to add first-aid devices such as patient monitors, mid- to low-end CT scanners, small portable oxygen generators, heart rate restorers, and ventilators.
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