상품DB/브라질 일회용 안대 시장동향(2013.3)

[일출산]

제목

브라질 일회용 안대 시장동향(2013.3)

게시일

2015-12-03

국가

브라질

작성자

문정화(리우데자네이루무역관)

품목

기타

품목코드

3005109000

작성일자: 2013.3.1

작성자: 리우데자네이루 무역관 Pablo Serejo (amychae.kotra@gmail.com)

1. Jaundice in Brazil

 ○ The results of a pioneering program for monitoring and treatment of newborns with jaundice      have just been released by the team Neonatology Center of Integral Attention to Women's Health(Caism) Unicamp(University of Campinas/ SP). Jaundice is characterized by yellowing of the skin and mucous membranes, is caused by the accumulation in the blood of bilirubin, a bile pigment.

 ○ Normally, bilirubin is changed by the baby's liver for disposal. If such removal is not effective, there is the physiological jaundice (or hyperbilirubinemia), which at high levels causes lesions in the central nervous system. Brain damage from jaundice - condition called kernicterus - bring sequelae such as deafness and motor problems, and can even lead to death.

 ○ The program eval‎uated all newborns in Caism weighing over 2 pounds, minimum gestational age of 35 weeks and without birth complications, from April 2001 to August 2005. Of the total sample of 11,259 children, 2,452(21.8%) were icteric and justified outpatient treatment. Eighty had to be readmitted for treatment with phototherapy.

 ○ An article with these results was published in the latest issue of the Journal of Pediatrics, important journal in the field, accompanied by laudatory editorial of a leading expert in the world jaundice, Indian Professor Vinod Bhutani, Stanford University School of Medicine.

 ○ Signed Article doctors Fernando Perazzini Facchini, Maria Aparecida Mezzacappa, Izilda Machado Rodrigues Rosa, Francisco Filho Mezzacappa, Abimael Aranha Netto and Sergio Tadeu Martins Marba, all of Caism and teachers of the Faculty of Medical Sciences.

 ○ Compliments of Vinod Bhutani proceed because there may be not in the world a literature survey so discerning about the incidence of jaundice and its various degrees. Furthermore, we elaborated an effective and inexpensive for detection and prevention of a disease that has been neglected by Brazilian and foreign hospitals.

 ○ Alert USA - Professor Fernando Facchini, who coordinates the team Caism explains that during physiological jaundice is almost always benign, with the natural normalization of bilirubin with the passing days. "But there are diseases that cause jaundice, when present, may be manifested with much more intensity and causes lesions in the nervous system," he warns.

 ○ According to Facchini, the kernicterus, which seemed controlled due to advances in neonatology, is resurgent in recent years. "The United States recorded more than 150 cases well characterized (and that does not represent the total). This triggered a campaign of zero tolerance, because there is no reason for the child from suffering the injury before the ease of detection and treatment of jaundice."

 ○ The Unicamp professor notes that brain injuries by jaundice reappear at a time when hospitals follow the global trend to shorten the maximum length of stay of patients. One goal of the measure is to reduce the risk of infections, but the main thing is the cost reduction.

 ○ "The hospital postpartum, which lasted an average of five days, now rarely passes 48 hours. In the United States, it can last less than a day: the mother enters, gives birth and leaves with the baby. The Americans themselves play that motherhood became a drive-thru, "Fernando compares Facchini.

 ○ This early hospital discharge creates a serious problem in relation to jaundice, which coincides with the physiological stage adaptation of the newborn to conditions outside the womb. Imperceptibly at first, jaundice has its peak in the third or fourth day of life, when the mother is already at home without medical supervision.

 ○ "What you do is advice the mother to observe the baby, but even those who have experience can be deceiving. I've seen episodes unpleasant, as a mother who alerted by the neighbor returned with the child showing very high levels of bilirubin." recalls Facchini.

 ○ The program - The debate over zero tolerance in America inspired the Caim team to create a structure outpatient with low cost for quality assessment. While the American Academy of Pediatrics recommends that all newborns undergo laboratory tests - with sophisticated methods, high cost and lengthy results - the Unicamp team tried to adapt a scheme to Brazilian conditions.

 ○ Before hospital discharge, all infants underwent clinical examinations. One of the tools is icterometer, with which it presses the tip of the nose and observing the skin color region. It was this initial assessment has determined that the incidence of 21.8% of children with bilirubin level requiring monitoring.

 ○ Depending on the level, children mothers were advised to return in 24, 48 or 72 hours for further assessment in a simple outpatient, assembled specifically for this purpose. The most celebrated by Fernando Facchini is a return of 87.2% of children. "It was a success, especially considering that mothers are poor and many live in distant suburbs or other cities."

 ○ Around 2,140 of the total 2,452 babies at risk, returned. According to the program coordinator, must be attributed to the ability of convincing physicians. "They helped the mothers understand that jaundice, although potentially serious, is easily controllable. Therefore, negligence is not justified."

 ○ Nomogram - For outpatient examinations, the team Caism resorted to a method developed by Vinod Bhutani which became a reference for classifying the degrees of jaundice. It is a nomogram(chart) that associates the hours of life with the newborn bilirubin levels, thus establishing ranges risk of developing jaundice important.

 ○ Among children referred for outpatient treatment, 79.7% (1,706) were released after a consultation, 11.4% returned a second time, third time by 2.7%, and only 0.8% more times. In the course of the process, 5.4% (115) gave up monitoring. The 80 newborns readmitted - that could develop severe jaundice - responded quickly to treatment with phototherapy.

 ○ A team of Neonatology at Caism still watching newborns and it is estimated that the cases detected since 4000 reach, but Facchini believe that the incidence is maintained close to 22%. "Importantly, we show it is possible to significantly reduce the costs of detection and monitoring cases of jaundice, without incurring in increased risk to children."

□ Jaundice in Brazil

 ○ In new project approved by FAPESP, the team of Professor Fernando Facchini will study two genetic mutations related to jaundice. One is caused by a deficiency of an enzyme called G6PD associated with prolonged neonatal jaundice. Another is Gilbert's syndrome, an   intermittent juvenile jaundice.

 ○ "The goal is to try to establish the preval‎ence of these two genetic causes in Brazil and correlate them with the cases of jaundice reported in Caism. We want to see if in very severe cases of jaundice, children also have G6PD deficiency, Gilbert's syndrome, or both problems together. It is a job that should be completed by the end of 2008." says Facchini.

 ○ Another novelty relates to the treatment. Currently, the only recourse at Caism is phototherapy, offering a device with an intense radiation: 14 fluorescent lamps, half above and half below the baby, which modify the bilirubin promoting their elimination. The child does not spend more than 48 hours in treatment.

 ○ Soon, Fernando Facchini expects to have a device for phototherapy with a blanket of fiber called 'blanket' which certainly facilitate the treatment of some newborns. Instead of receiving the projection of light, the baby is lying on the blanket. "The impediment was the price of the imported product, around 25 thousand dollars. But we are to receive a national version, we got to test a few years ago, but only now has provisional approval from Anvisa

2. Country Statistics on Imports

3. Economic Data

 ○ Here a general import & export information of the different medical sectors.

Exports Value

                                                                        (Unit: US$ million)

Segment	2009	2010	2011
Dentistry	70,4	84,5	86,2
Laboratory	32,0	55,8	63,2
Radiology	22,6	25,2	24,1
Equip. Medical Hospital	46,0	47,3	71,6
Implants	94,8	103,6	122,8
Consumables	276,0	312,1	339,2
Total Exports	541,8	628,4	707,1

       Source: http://www.abimo.org.br/

Imports Value

                                                                        (Unit: US$ million)

Segment	2009	2010	2011
Dentistry	45,8	59,3	79,9
Laboratory	720,0	884,0	1.035,9
Radiology	539,4	681,2	717,9
Equip. Medical Hospital	439,2	726,2	684,1
Implants	453,0	550,7	628,6
Consumables	577,5	753,9	919,9
Total Exports	2.774,9	3.655,2	4.066,3

       Source: http://www.abimo.org.br/

Commercial Balance

                                                                        (Unit: US$ million)

Operation	2010	2011
Export	633	707
Import	3.667	4.066
Balance	-3.004	-3.359

       Source: http://www.abimo.org.br/

4. Economic Data

 ○ The main regulatory authority in Brazil is the National Health Surveillance Agency(ANVISA), under the auspices of the Ministry of Health. The basis for market regulation is Law No. 6360/76, which has been updated on several occasions since its introduction. ANVISA’s writ extends to agrochemicals, food safety and enforcing regulations on the advertising of alcohol and tobacco.

 ○ A programme for the modernization of ANVISA’s management framework and a ten-year strategic plan was presented by the agency’s president, Dirceu Raposo de Mello, in the 27th Forum of Planalto in August 2010. The regulator proposed a 10-year strategy that includes the de-bureaucratization of processes and rational organization of drug approval applications. ANVISA, created just over a decade ago, has since then made significant progress in consolidating its role as the main regulatory body in the country.

 ○ The agency has been criticized for overreaching in terms of its regulation – which it was said should be left to the legislature – as well as failing to effectively enforce internationally recognized standards. In October 2011, the regulator’s decision to approve the saleand marketing of a widely banned weight loss supplement sibutramine, even under strictconditions, raised concerns about patient safety. It’s noted that the drug’s sales were restricted in the US after the Food and Drug Administration(FDA) linked it to an increased risk of heart attacks and strokes. The drug was also withdrawn from European markets after an outcomes trial report showed the risk of myocardial infarction increasing by about 15% in people who took the drug. Argentina, Uruguay and Colombia have also banned the drug.

 ○ Along with complaints about the scope of ANVISA’s powers and deficiencies in underlying legislation, the agency was also criticized for its slow speed.

  - Siscomex has implemented compulsory certification of good manufacturing practice(GMP) guidelines for international drug makers exporting to Brazil and the implementation of a recall system, which allows the immediate withdrawal of products that have quality variations or are under suspicion. As a result, quality standards for products are generally high. The agency has demonstrated its commitment to reinforcing its standards. For instance, as a result of strict inspections it has withdrawn GMP certificates for almost 30 companiesover the past five years.

 ○ ANVISA’s last major update to GMP certification standards was in 2003, in response to recommendations by the World Health Organization(WHO). In late 2010, the agency conducted a public consultation for the introduction of similar regulation to the manufacturing of APIs, introducing standard procedures similar to those of the US, Europe and Japan.

 ○ The pharma covigilance in Brazil as fairly well developed in comparison with many emerging markets, with standards largely comparable to those in developed markets. The National System of Notifications to the Sanitary Service(Notivisa) is used to transmit incidences of adverse drug reactions(ADRs) to ANVISA. The regulator has banned several chemicals, agrochemicals, foods and medicines from sale in the country, when it found that these products posed a risk to the population.

 ○ ANVISA does not recognize foreign quality compliance certificates. In August 2010, the agency suspended imports of Schering-Plough’s Onicit(palonosetron) – an anti-nausea drug for patients on chemotherapies – after irregularities in the US-based OSO Biopharmaceuticals manufacturing plant were discovered during its own inspection.

 ○ The regulator may represent an obstacle to market entry due to the overbureaucratisation of procedures. For example, the Acre state government has had to give up the purchase of a large number of medical equipment from foreign suppliers due to administrative obstacles encountered by the Brazilian Association of Certified Companies – Good Practices of Manufacturing(ABECbpf).

 ○ According to ANVISA’s RDC 59/00 regulation, foreign firms interested in exporting to Brazil are required to certify products through submission of a request for inspection, which must be made through representatives or registered importers. Generally speaking, while large multinational drug makers welcome the improvements in regulatory standards in the country, bureaucracy levels represent a significant obstacle to small and medium-sized foreign drug makers wishing to enter the Brazilian market who do not already having subsidiaries or partners in the country.

□ Healthcare Sector

 ○ The country has made significant inroads on public health. By way of illustration, average life expectancy in Brazil reached 72.3 years in 2006, which is an increase of 15% on the 1980 figure of 62.6 years. The Brazilian Institute of Geography and Statistics(IBGE) attributes the rise to more practicing doctors, better access to clinics and hospitals and greater uptake of medicines, especially vaccines for children. As with many countries, there is a large gender gap, with women(76.1) living nearly eight years longer than men(68.5). The health system’s lingering inequalities are still manifest, reflecting the dramatic gulf between rich and poor in the country. More concretely, many chronic and critical diseases such asdiabetes, as well as many forms of cancer, go untreated due to a lack of  preventative care.

 ○ A growing population and the continued growth of the Brazilian economy have resulted in an increase in affordability and demand for private healthcare. The market for private healthcare will continue to show strong growth given the positive long-term economic outlook for the country. However, profit margins for private healthcare providers have recently become less attractive, with a ruling by the high court – Supremo Tribunal Federal(STF) – determining that private healthcare providers are to reimburse the Brazilian public healthcare system – Sistema Único de Saúde(SUS) – in the same way that private hospitals are currently reimbursed for treating privately insured patients.

 ○ Brazil’s healthcare market is notable because the private and public sectors are similar sizes in expenditure terms, unlike in most other countries, where one sector dominates. While the difference in public and private care is stark in Brazil, the disparity is made worse by the country’s emergence as the cosmetic and plastic surgery destination of choice for medical tourists in South America. While relations between the two sectors have been stable in the past, it’s possible to note that regional labor disputes and rising demand from medical tourists have encouraged private specialists to demand increased wages far above their public counterparts. In April 2011, close to 80% of the country’s doctors joined a national mobilization event to protest against its increasingly segregated healthcare system, with protests continuing in both public and private sectors. We believe this two-tier medical system could have dramatic social implications if left unaddressed.

5. ANVISA (Website: http://www.anvisa.gov.br/eng/system/index.htm)

 ○ The National Health Surveillance Agency(ANVISA) was established by Law 9.782, of January 26,1999.

     The Agency is designated an autonomous agency operating under a special regime. This means that ANVISA is an independently administered, financially-autonomous regulatory agency, with security of tenure for its directors during the period of their mandates. The Agency is managed by a Collegiate Board of Directors, comprised of five members.

 ○ Within the structure of Federal Public Administration, the Agency is linked to the Ministry of Health, under a Management Contract. The agency incorporated additional attributions: coordination of the National Sanitary Surveillance System(SNVS), the National Program of Blood and Blood Products and the National Program of Prevention and Control of Hospital Infections; monitoring of drug prices and prices of medical devices; attributions pertaining to regulation, control and inspection of smoking products; technical support in granting of patents by the National Institute of Industrial Property.

 ○ The institutional purpose of the agency is to foster protection of the health of the population by exercising sanitary control over production and marketing of products and services subject to sanitary surveillance. The latter embraces premises and manufacturing processes, as well as the range of inputs and technologies concerned with the same. In addition, the Agency exercises control over ports, airports and borders and also liaises with the Brazilian Ministry of Foreign Affairs and foreign institutions over matters concerning international aspects of sanitary surveillance.

6. Documentation of education of the application for recognition

□ Purpose for Exemption of Import Tax

 ○ Application of Sanitary Inspection and Release of Goods and Imported Products - ANVISA;

 ○ Application for recognition purpose for Import Tax Exemption Medical and Hospital for material under this Regulation

 ○ Guide to Gathering of the Union of National Treasury, as provided in relevant health legislation

 ○ Extract Import License or Simplified Import Licensing, updated (copy)

 ○ Information about the regularization of the product at ANVISA, when appropriate

 ○ Statement issued by the holder of the document to stabilize the product in ANVISA, authorizing importation by third parties, when appropriate;

 ○ Declaration signed by the legal representative of the Company, a commitment to: The good or product will be imported for the exclusive use of importing institution, indicating The site of installation, use or consumption of the good or product, as applicable

 ○ Power of attorney from the importer with delegated powers at ANVISA, as applicable

  - Petitioning for sanitary inspection and clearance;

  - Monitoring the stages of technical analysis for the purpose of granting the letter of Recognition purpose for exemption from import tax

  - A document signed by the legal representative of the person concerned about the nominal legally qualified staff to implement the powers delegated to the instrument attorney that deals with the preceding paragraph.

  - Identification of legal and other related documents

  - Presentation of defenses, such as appeals

 ○ Specify the name and address of the place where the bonded warehouse customs clearance.

□ The hospital must file in the office of the ANVISA in place of customs clearance, the application of sanitary inspection with the relevant documentation, as chapter XXXIX of DRC 81/08.

□ Additional information may be obtained from the Management Ports Airports and Borders by e-mail: gipaf@anvisa.gov.br or by telephone: (55 61) 3462 5571/3462 5544.

□ The Legal Department FEHOESP is also available to resolve any doubts about the issue, by e mail:juridico@fehoesp.org.br

7. Provides for the Technical Regulation of Goods and products imported into purposes of Health Surveillance (Technical regulation on goods and imported products for your health surveillance)

□ General provisions for import

 ○ Imports of goods or products under sanitary surveillance must be preceded by the favorable opinion expressed the health authority in the form of this Regulation.

  - It will only be allowed to import, supply consumption, exposure for sale or to human health at any Title of goods and products under sanitary surveillance, that meet the health requirements mentioned in this Regulation and the relevant health legislation.

   · The goods and products under sanitary surveillance, intended for trade, industry or direct consumption should have the imports allowed are formally settled to the National Surveillance System Health regarding the obligation, as applicable, registration, notification, registration, authorization model, exemption from registration, or otherwise control regulated by the National Surveillance Health.

   · The authorization to import goods and products under sanitary surveillance person or entity shall be given from mandatory compliance with technical and administrative guidelines and application through petitioning, electronic or manual, available and regulated by ANVISA.

   · The information members of petitioning, electronic or manual, that comes on the above item imports of goods and products in the form of this Regulation should correspond faithfully to obtained when its inspection and sanitary inspection.

  - Emergency or temporary, considering the international epidemiological context, human, animal or plant, or the deployment of public health programs related to sanitary control of goods and services and individuals or companies involved in manufacturing and service provision, the authority health may prohibit the importation or entry of goods or products mentioned in subsection I of Chapter 1:38 of this Regulation.

  - It is for the importer and/ or holder of the regularization of the product for compliance with the obligation and compliance legal and regulatory standards, measures, procedures and requirements to the administrative process of import in all its stages, from boarding on the outside to release health in the country.

   · It will include the provisions of this item the obligation to adopt measures reputable, fit and with third parties contracted for import of goods or products under sanitary surveillance, to avoid or prevent injury to Health.

   · The provisions of this item shall not exempt the third party contracted to perform and observe the rules and regulations legal measures, procedures and requirements laid down in this Regulation.

  - Importation of goods and products under sanitary surveillance in tariff classification - NCM/ SH - not provided for in Chapter XXXIX of this regulation, the health authority will be relieved of performing before the SISCOMEX operations requirement, authorization for shipment and acceptance or refusal of the Licensing imports.

   · The provisions of this item do not relieve the sanitary inspection.

  - The deadlines for the measures, procedures and requirements laid down in this Regulation shall be counting from the first working day following the date of receipt.

  - Imports of goods or products in the Special Drawback shall meet the provisions of this Regulation.

8. Rules for Import

□ Section 1: The Siscomex - Imports module

 ○ Subsection 1: General Provisions

  - Imports of goods and products subject to non-automatic licensing in the Integrated Trade Exterior - Siscomex arranged in Chapter XXXIX of this Regulation, for the person or entity of public or private, shall be subject to mandatory prior express consent by ANVISA approval of the import license, as an integral entity of the system.

  - The importer of goods and products under sanitary surveillance in addition to meeting the health requirements set forth in this Regulation for the different purposes of importation, shall submit to the competent health authority of ANVISA demand a health inspection and clearance of imports through petition for review and sanitary clearance mentioned in subsection 1.2. Chapter 2 of this Regulation.

 ○ Subsection 2: Registry Import License

  - The registration of the import licensing should be done by the importer or his legal representative, enabled through the Siscomex Import Module.

   · The importer will be liable to the competent health authority for the classification of the product in Administrative Treatment Table, Siscomex.

   · The importer of goods and products subject to non-automatic licensing shall be required to register by Fill in the boxes of 'Sheet Supplier' Import License-LI in Siscomex, the information related to the manufacturer and exporter.

   · The importer of apparatus, instruments and accessories members of the class of medical products will be bound to register in the fields of 'good form' Import License-LI in Siscomex information regarding:

     a) Product identification, name, specification (each specification must correspond to an item) and model or commercial presentation, as well as the parts and accessories accompanying it;

     b) Condition of the product, whether new or refurbished.

   · The importer will be required to register in the 'additional information' License Import-LI:

     a) Number or code for the regularization of the importing company in respect of the Operating Permit Company specifying the activity (s) in the case of import of products belonging to classes drugs, cosmetics, perfumes, toiletries, disinfectants, medical products, for in vitro diagnostics, raw materials and inputs for the pharmaceutical industry, as well as imports outsourced in account status and order;

     b) Number or code for the regulation of food importing company in respect of License / Permit Working with the national health authority;

   · In the field of 'good form' Import License-LI, the adjustment of the product and its validity in the National Health Surveillance - SNVS.

  - The import of products for industry and commerce shall make shall be exclusively by means of record in Siscomex Import Module, while respecting the guidelines for all purposes of import provided for in other Chapters of these Rules.

  - Imports of goods and products when subjected to non-automatic licensing-LI - Siscomex arranged in The MERCOSUR Common Nomenclature - NCM, must meet the requirements and administrative procedures members of the documentary Chapter XXXIX of this Regulation.

 ○ Subsection 3: Authorization Shipping Import Licensing

  - It will not be granted for the shipment or acceptance of the Import License-LI, goods and products incorporating administrative procedures described in Chapter XXXIX, which do not meet health requirements laid out in these Regulations or other statutes in force health.

  - The technical analysis of the ANVISA sanitary authorization for shipment abroad in licensing importation of goods or products under sanitary surveillance lose their effect, for the purposes of this Regulation, 120 days after its approval by the health authority.

   · Delete will be the provisions of this item to the technical analysis for purposes of authorization for shipment abroad in licensing of imports of goods or products under sanitary surveillance, linked to public programs health or scientific research, technology and innovation(as the Act) will lose its effect, for purposes of this Regulation, 360 days from the date of your protocol on ANVISA.

 ○ Subsection 4: Acceptance of the Import License

  - The granting of the Import License by ANVISA will involve surveillance of goods and products before customs clearance at the discretion of the competent health authority or whenever so required by Under this Regulation.

  - The granting of the Import License shall be give after compliance by the importer of the requirements health or in cases falling within Chapters of these Rules.

 ○ Subsection 5: Licensing Import Substitute

  - The consent of the Import License Substitute by the health authority will occur from context tax, is conclusive and satisfactory, linked to the import licensing that preceded it, since the amendment replacement provided that this record - Siscomex - Import Module, has been informed and is not present at odds with the supervision and/ or completion of the sanitary inspection history.

   · For cases of substitution of LI due to changes in specific information of a monetary, foreign exchange and tax, without implications for the sanitary inspection and whose departure has already been permitted in the LI replaced is excused from the LI substitute new manifestation of the technical field concerned.

 ○ Subsection 6: Validity of the Import Process

  - The import process/ DATAVISA containing the petition mentioned in Chapter II, subsection 1.2, after the within 150 days of its protocol with ANVISA must be filed and dismissed, by the Information System Datavisa.

  - The import process, mentioned in subsection 7.1, containing the petition mentioned in Chapter II, subsection 1.2., after the deadline will be rejected and filed with the Information System Datavisa.

□ Section 2: Shipping express shipping postal international air and order

 ○ Imports of goods or products via express delivery, mail or air parcel international, for the person or entity, public or private, shall be subject to mandatory health requirements laid down in this Regulation, other health conditions, or determined by the authority Health.

  - Form will need health the sanitary inspection prior to customs clearance and delivery for exposure or human consumption.

  - Is authorized, in the development of health surveillance in customs facilities installed in companies operating mail or express delivery, the use of technical resources provided by equipment scanners, in order to view and perception of products under surveillance.

   · The preview mentioned in the previous subsection should serve as guidance for the implement of fiscal behavior more accurately, the tax cannot be covered daily in 100% of the goods or products under its competence.

 ○ Will be prohibited from entering the territory of:

  - Prohibited goods and products referred to in this 1A Procedure Rules and other normative acts externalized by the Boards that make up the Directorate of Collegiate ANVISA.

  - Goods and products devoid of identification in their primary packaging and / or secondary documents.

 ○ The competent health authority in the exercise site clearance, is authorized to grant rejection health and the immediate, material or product in import, that it had authorized its nationalization by unmet health requirements in force in the country.

  - Shall be excepted from the provisions of goods, materials or products whose operations management for the rejection, endanger the health of people in international transport or occupationally exposed.

 ○ The goods or products under sanitary surveillance pursuant to this Chapter cannot be characterized in quantity imported or frequency of importation, trade or resale purposes.

 ○ Subsection 1: Express Shipping

  - The express delivery company responsible for importing the goods or products under sanitary surveillance should submit to the competent sanitary authority of ANVISA the ballot through the petition for review and release health mentioned in subsection 1.2. Chapter II of this Regulation, the following documents:

     a) Knowledge of cargo shipped linked to imports - MAWB and HAWB.

     b) Guide to Gathering of the Union, the National Treasury - GRU, as provided by law relevant health.

   · The document mentioned in the previous paragraph, paragraph 'a', should be presented in its original form carbonated or electronic, which will be retained.

   · Required information will be considered for technical analysis of imports by the authority health and must present in cases of imports made by a legal entity:

     a) Trade name, in the case of bulk or finished product, when appropriate;

     b) Name of the active base of the drug formulation;

     c) The common name or technical name, chemical or biological asset or product when it is input or feedstock for the production of medicines, cosmetics, perfumes, toiletries, and sanitizing products for in vitro diagnostics;

     d) The name of the raw food;

     e) Purpose of importation, as Table I of Chapter XL of this Regulation, in cases of imports by legal entity;

     f) The product class in accordance with paragraph 1:38 of Chapter I of this Regulation;

     g) Nature of the product, according to Table II of Chapter XL of this Regulation, in cases of imports by legal entity;

     h) Of the medical condition (new or reconditioned);

     i) Name of carrier and when appropriate the CNPJ;

     j) The name, Tax ID or social security number and full address of the importer of the product;

     l) Name and full address of the sender of the product.

   · Additional information will be considered at the discretion of the health authority for analysis conclusive technical import, in case of imports made by individuals for personal use or individual quantity and frequency not set trade:

     a) Trade name in the case of finished products when appropriate;

     b) Name of the active base of the drug formulation;

     c) Purpose of importation, as Table I of Chapter XL of this Regulation;

     d) Class of the product in accordance with subclause 1:38 of Chapter I of this Regulation;

     e) Nature of the product, according to Table II of Chapter XL of this Regulation;

     f) Of the medical condition (new or reconditioned);

     g) The name, Tax ID or social security number and full address of the recipient of the product;

     h) Name and full address of the sender of the product.

 ○ Subsection 2: Postal Remittance

  - Which must contain the external packaging of mail order, the information on general identification(s) well(s) or product(s) imported under sanitary surveillance and the name and address of recipient.

  - Additional information will be considered at the discretion of the health authority for the purpose of technical analysis conclusive import:

   · Trade name in the case of finished products when appropriate;

   · Name of the active base of the drug formulation;

   · Purpose of importation, as Table I of Chapter XL of this Regulation;

   · Class of the product in accordance with subclause 1:38 of Chapter I of this Regulation;

   · Nature of the product, according to Table II of Chapter XL of this Regulation;

   · Of the medical condition (new or reconditioned);

   · The name, Tax ID or social security number and full address of the recipient of the product;

   · Name and full address of the sender of the product.

 ○ Subsection 3: Air International Order

  - The company that operates in scheduled air transport service responsible for import ordering air international food and medicine of continuous use or nutritional particular for the individual resident in the country, will present the good or product to the competent sanitary authority of ANVISA the following documents:

   · Statement for the relevant customs clearance;

   · Prescription in accordance with paragraph 4, Section II, Chapter XII;

   · Invoice or statement of acquisition;

   · Authorization from the consignee for customs clearance.

□ Section 3: Simplified reporting of not import electronic

 ○ Imports of goods or products for the person or entity, public or private, whose Customs clearance is effected by means of Simplified Import Declaration - DSI, not electronics, must be the sanitary requirements set forth in this Regulation and certain other authority Health.

  - Form will need health the sanitary inspection prior to customs clearance and delivery for exposure or human consumption.

 ○ In addition to meeting the health requirements laid down in this Regulation for different purposes import, the importer shall submit to the competent sanitary authority of ANVISA's vote sanitary inspection and clearance of imports through petition for sanitary inspection and clearance that is the subsection 1.2. Chapter II of this Regulation accompanied, where applicable, the following documents:

     a) Knowledge of cargo shipped linked to imports - MAWB and HAWB, as applicable;

     b) Guide to Gathering of the Union, the National Treasury - GRU, as provided by law relevant health.

   · The document mentioned in the previous paragraph, paragraph 'a', should be presented in its original form carbonated or electronic, which will be retained.

   · Required information will be considered for technical analysis of imports by the authority health and must present:

     a) Trade name, in the case of bulk or finished product, when appropriate;

     b) Name of the active base of the drug formulation;

     c) The common name or technical name, chemical or biological product, when dealing with raw material or feedstock for the production of medicines, cosmetics, personal hygiene, and sanitizing products in vitro diagnostics;

     d) The name of the raw food;

     e) Purpose of importation, as Table I of Chapter XL of this Regulation;

     f) Class of the product in accordance with subclause 1:38 of Chapter I of this Regulation;

     g) Nature of the product, according to Table II of Chapter XL of this Regulation;

     h) Name of carrier and CNPJ when appropriate;

     i) The name, Tax ID or social security number and full address of the importer of the product;

     j) Name and full address of the sender of the product.

9. Competitors

□ NewMed

Website: http://www.newmed.com.br/index.php?loadpage=produto&subcat=17&prodid=36

  - The NewMed operates for over twenty years providing solutions with proven quality and highdegree of innovation in the areas of Prevention of Nosocomial Infections, Respiratory Therapy, Neonatology, Anesthesia, Emergency Oxygen Therapy and Clinical Investigations.

  - Since its founding in 1989, stands out in the market by offering its customers and businesspartners personalized service, combined with technical expertise, fast delivery and competitive prices.

  - Today NewMed also develops some own brand products through the company Make Line and recently acquired Medcir - Medical Surgical, a company with nearly 70 years of market that operates in the areas of electro surgery, Electrotherapy and Fetal detectors.

□ Impacto

Website: http://www.impactomedical.com.br/?portfolio=latest-design-trends

  - Impacto is a company that manufactures and distributes products for the medical hospital, high quality nationwide.

  - Its philosophy is the introduction of new products for intensive care, anesthesia, surgery, respiratory therapy, orthopedics and home care.

□ Kors do Brasil (Surgibaby)

 Website: http://www.korsdobrasil.com.br/prod_hosp5.html

  - Kors of Brasil, founded in 1990 by partners Dr. Silvio Elie Halpern and A. Matalon, introduced in the Brazilian market new technologies and features that are making life easier for patients, doctors and nurses.

  - The company started importing products only first line that came to fill a gap in the area of healing, lowering costs for hospitals and clinics, offering comfort and welfare to patients, from newborn to adult.

  - For all this to happen, we have partnered with the Fra spa production, Italy, bringing its product line with total exclusivity, launching in the Brazilian market a new concept of dressing that has revolutionized a change of habit and that has existed for over 40 years in Europe. Within this line highlighted: Surgifix(elastic tubular mesh),

  - Singlefix(bandage sterile, ready to use: toes and hands), Unislip(elastic pants ready for use), Bimbofix(dressing ready for umbilical hernia and other) and Shield eye for phototherapy(Surgibaby).

10. Distributors

□ Cirurgica Passos

   Website: http://www.cirurgicapassos.com.br  

  - Traditional Business Branch hospital acting nationwide, was designed from important experiences in the pharmaceutical area of its founders.

  - Its philosophy is directed to effective assistance of health professionals and the general public, with a team of trained employees with a high level of knowledge about the products it sells.   

  - Works since 1982 with medical equipment and furniture, assemblies ICUs, surgical centers, healthcare facilities and medical practices of any specialty. There is also now a wide range of equipment for occupational medicine clinics and companies.

  - It has a physical store in the center of the capital of Paraná - Curitiba. Possesses a system of buying on the internet with full security to the buyer by accepting credit cards: visa, mastercard, american express and diners and other payment methods to choose from. All products site contains technical specifications and special prices.

  - Along with his New Logistics Center with more than 1,400㎡, offer ways to deliver faster and more agile with the convenience of the Internet.

□ Medical Fast

 Website: http://www.medicalfast.com.br/ecommerce_site/produto_

12116_7153_Protetor Ocular-Neonatal-para-Fototerapia-Trach-Fix

  - Medical fast is a company that was founded by professionals working for many years in health (doctor and hospital) with deep knowledge in quality processes and risks involved in the sector.

  - All our products are selected according to criteria of quality certifications and processes thatensure our customers are getting what is best in the market in terms of quality, safety and cost effectiveness.

  - The main goal, the satisfaction of our customers from the moment of consultation and research of a product of interest, until completion and receipt of the request. We offer solutions, so we work with several product lines for our customers to find the best value within your budget and need.

  - A Medical fast offers all products in your store by creating a direct link with his client in various segments.

 ○ Market price range : From R$20 to R$29 / US$10 to US$14.50.