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Registration of Health Products/Medical Products in Brazil
| 작성자 | 관리자 | 카테고리 | 전문가 인사이트 |
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| 작성일 | 2017-05-10 | 조회수 | 1,980 |
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Registration of Health Products/Medical
Products in Brazil
- 글 Vera Lucia M Noguchi
- GPKOL 위원
경력사항
- 2007-현재 Instituto Vital Brazil SA QA/RA Manager
- 1998-2007 CENTRALERG Ltda QA/RA Manager
세부 전문분야 및 컨설팅 내용
- 인허가
1. Introduction
1.1The Market for health products in Brazil
Brazil is considered a "global player" in the area of equipment and medical products or health products, according to results of perception surveys conducted at the main international event of the services and products sector in the world, held in Düsseldorf, Germany.(1)
The country is also considered the seventh world market in health products. This sector accounts for about 5% of the country's total health expenditures. Currently, the health products sector has a 0.6% share of Brazilian GDP, has more than 13 thousand companies and generates around 140 thousand jobs.(2)
According to the Brazilian Association of High Technology Products Industry for Health (ABIMED), the health products sector is traditionally one of the most innovative in the world. It is a market that globally moves around US $ 350 million a year, which closed 2015 with a turnover of around US $ 11 billion in Brazil and which invests from 8% to 12% of its sales in research and development. However, the market for medical equipment and products, which moved such attractive number in 2015, decreased in the first half of 2016. "The sector was impacted by the economic recession, there were cuts in the area of Health and the drop in government revenue caused a reduction in their investments. The Government accounts for about 50% of the purchases of the sector ", analyzes the executive president of ABIMED.(3)
1.2 Historical of Sanitary Legislation in BrazilThe country is also considered the seventh world market in health products. This sector accounts for about 5% of the country's total health expenditures. Currently, the health products sector has a 0.6% share of Brazilian GDP, has more than 13 thousand companies and generates around 140 thousand jobs.(2)
According to the Brazilian Association of High Technology Products Industry for Health (ABIMED), the health products sector is traditionally one of the most innovative in the world. It is a market that globally moves around US $ 350 million a year, which closed 2015 with a turnover of around US $ 11 billion in Brazil and which invests from 8% to 12% of its sales in research and development. However, the market for medical equipment and products, which moved such attractive number in 2015, decreased in the first half of 2016. "The sector was impacted by the economic recession, there were cuts in the area of Health and the drop in government revenue caused a reduction in their investments. The Government accounts for about 50% of the purchases of the sector ", analyzes the executive president of ABIMED.(3)
The Legal Organization of the country is based on the Federal Constitution (CF) of 1988, which brings in its articles 196 to 200, the general concepts on Health in Brazil. In order to make these concepts explicit, specific Laws are issued, which are regulated through Governmental Decrees. Also, regarding health, the Ministry of Health and the Regulatory Agency, ANVISA, issue the Ordinances, Resolutions, Normative Instructions, Technical Notes, in order to complement and to detail the legal framework of health in Brazil.
In 1953, was created in Brazil, the Brazilian Ministry of Health (MS), an agency of the Federal Executive Branch, which has, among others, the important responsibilities of overseeing the application of national and international health legislation and other legislation of public health interest; to issue marketing authorization or withdrawal from the national market for medicines, pharmaceuticals and phytotherapeutics.
Although the Ministry of Health was created in 1953, it was only in the 1970s that the country's main Health Laws were created, which are still in force:
• Law 5.991/1973 - Law that deals with sanitary control of the trade in drugs, medicines, active pharmaceutical ingredients and correlates. Products such as food, sanitizers and cosmetics were classified as correlates. Currently, in Brazil, Correlates is synonymous with Products for Health or Medical Products. This Law brings concepts that are used today. It is worth emphasizing the definition of correlates, according to the cited Law: "Correlates - the substance, product, apparatus or accessory not framed in the previous concepts, of drug, drug or active pharmaceutical ingredients, whose use or application is linked to the defense and protection of personal or collective health, personal or environmental hygiene, or for diagnostic and analytical purposes, cosmetics and perfumes, as well as dietetic, optical, medical acoustic, dental and veterinary products.”
• Law 6.360/1976 – Law that establishes the sanitary surveillance of goods and services of interest in health. It inserts concepts of Drugs, Medicines, Active pharmaceutical ingredients, Correlates, Cosmetics, Sanitizers and Other products. After this Law, Correlates refers only to Health Products / Medical Products.
• Law 6.437/1977 – Law that configures infractions to the federal sanitary legislation and establishes the respectives sanctions or penalties.
• 1988 – Federal Constitution – Promulgated the Federal Constitution, which aims to guarantee social, economic, political and cultural rights; Establishes Health as a universal right and duty of the State, with the creation of the Unified Health System (SUS).
• Law8.080/1990 – Law that regulates the Unified Health System (SUS), created in the Federal Constitution, and is responsible for executing the Sanitary Surveillance in Brazil.
• Law 9.782/1999 – Establishes the National Health Surveillance System and the creation of the agency, ANVISA. Before, the Vigilance was exercised through a Secretariat within the MS, which regulated products and companies through the health laws created in the 1970s. The Health Surveillance function is still of the MS, but the activity is performed by ANVISA.
• Decree 8.077/2013 – Regulates the conditions for the operation of companies subject to Sanitary Licensing; Registration, Control and monitoring of products covered by Law n° 6.360/1976, within the scope of Sanitary Surveillance.
1.3 Legal Base
Figure 1: Pyramid of Kelsen, with adaptations
In 1953, was created in Brazil, the Brazilian Ministry of Health (MS), an agency of the Federal Executive Branch, which has, among others, the important responsibilities of overseeing the application of national and international health legislation and other legislation of public health interest; to issue marketing authorization or withdrawal from the national market for medicines, pharmaceuticals and phytotherapeutics.
Although the Ministry of Health was created in 1953, it was only in the 1970s that the country's main Health Laws were created, which are still in force:
• Law 5.991/1973 - Law that deals with sanitary control of the trade in drugs, medicines, active pharmaceutical ingredients and correlates. Products such as food, sanitizers and cosmetics were classified as correlates. Currently, in Brazil, Correlates is synonymous with Products for Health or Medical Products. This Law brings concepts that are used today. It is worth emphasizing the definition of correlates, according to the cited Law: "Correlates - the substance, product, apparatus or accessory not framed in the previous concepts, of drug, drug or active pharmaceutical ingredients, whose use or application is linked to the defense and protection of personal or collective health, personal or environmental hygiene, or for diagnostic and analytical purposes, cosmetics and perfumes, as well as dietetic, optical, medical acoustic, dental and veterinary products.”
• Law 6.360/1976 – Law that establishes the sanitary surveillance of goods and services of interest in health. It inserts concepts of Drugs, Medicines, Active pharmaceutical ingredients, Correlates, Cosmetics, Sanitizers and Other products. After this Law, Correlates refers only to Health Products / Medical Products.
• Law 6.437/1977 – Law that configures infractions to the federal sanitary legislation and establishes the respectives sanctions or penalties.
• 1988 – Federal Constitution – Promulgated the Federal Constitution, which aims to guarantee social, economic, political and cultural rights; Establishes Health as a universal right and duty of the State, with the creation of the Unified Health System (SUS).
• Law8.080/1990 – Law that regulates the Unified Health System (SUS), created in the Federal Constitution, and is responsible for executing the Sanitary Surveillance in Brazil.
• Law 9.782/1999 – Establishes the National Health Surveillance System and the creation of the agency, ANVISA. Before, the Vigilance was exercised through a Secretariat within the MS, which regulated products and companies through the health laws created in the 1970s. The Health Surveillance function is still of the MS, but the activity is performed by ANVISA.
• Decree 8.077/2013 – Regulates the conditions for the operation of companies subject to Sanitary Licensing; Registration, Control and monitoring of products covered by Law n° 6.360/1976, within the scope of Sanitary Surveillance.
According to the Law n° 6.360/1976, Art. 12, “none of the products of this law, including those imported, can be industrialized, displayed for sale or delivered to the consumer before being registered by the Ministry of Health”. And according to the first paragraph, “the registration referred to in this Article shall be valid for 5 (five) years and may be renewed for equal and successive periods, maintaining the initial registration number”. It is also important to mention the Art. 13, in which it states that “any change of formula, changing elements composition or its quantitative, addition, subtraction or innovation introduced in the preparation of the product, require the prior written consent of the Ministry of Health and will be immediately communicated to the registration area of ANVISA”. Regarding the regulatory base, it is also important to mention the Decree no. 8.077/2013, which regulates the conditions for the functioning of companies subject to health licensing, registration, control and monitoring, as part of health surveillance of the products mentioned in Law n° 6.360/1976.
2. Registration of Health Products at ANVISA
In Brazil, Health Products or Medical Products basically comprises three cathegories: medical equipment, health use materials and in vitro diagnostic products.
The definition of Health Products, in accordance with Resolution ANVISA RDC N° 185/2001, is: "Health product, such as equipment, apparatus, material, article or system of medical, dental or laboratory use or application , which is intended for prevention, diagnosis, treatment, rehabilitation or contraception, and which does not use a pharmacological, immunological or metabolic means to perform its principal function in humans, but may be assisted in its functions by such means.”
Health products are classified in Classes I, II, III or IV according to the intensive risk they pose to the health of the consumer, patient, operator or third parties involved. In order to fit the medical product into one of these classes, the classification rules described in Annex II to Resolution 185/2001 should be applied. For the purposes of registration, provided for in Law 6.360/1976 and Decree No. 8.077/2013, the sanitary legislation separates the products in: (a) Health products subject to registration, which must be registered with ANVISA pursuant to Resolution RDC n° 185/2001; (b) Health products exempt from registration, referred to in paragraph first of Article 25, of Law n° 6.360, which must be regularized with ANVISA, by cadastre, pursuant to Resolution RDC n° 40/2015.
2.1 Register / Cadastre
2.2 Step by Step for the Cadastre / Registration of Health Products
The definition of Health Products, in accordance with Resolution ANVISA RDC N° 185/2001, is: "Health product, such as equipment, apparatus, material, article or system of medical, dental or laboratory use or application , which is intended for prevention, diagnosis, treatment, rehabilitation or contraception, and which does not use a pharmacological, immunological or metabolic means to perform its principal function in humans, but may be assisted in its functions by such means.”
Health products are classified in Classes I, II, III or IV according to the intensive risk they pose to the health of the consumer, patient, operator or third parties involved. In order to fit the medical product into one of these classes, the classification rules described in Annex II to Resolution 185/2001 should be applied. For the purposes of registration, provided for in Law 6.360/1976 and Decree No. 8.077/2013, the sanitary legislation separates the products in: (a) Health products subject to registration, which must be registered with ANVISA pursuant to Resolution RDC n° 185/2001; (b) Health products exempt from registration, referred to in paragraph first of Article 25, of Law n° 6.360, which must be regularized with ANVISA, by cadastre, pursuant to Resolution RDC n° 40/2015.
2.1 Register / Cadastre
The registration of a product subject to Sanitary Surveillance is the legal act that recognizes the suitability of a product to the current sanitary legislation, which is granted by ANVISA. It is a control made before the commercialization, being used in cases of products that can present possible health risks.
In order for products subject to health surveillance to be registered, it is necessary to comply with the criteria laid down by law and the specific regulations established by the Agency. These criteria aim to minimize possible risks associated with the product. The manufacturer or importer company is responsible for the quality and safety of products registered with ANVISA.
In order for a company to act in the area of Health Products it is necessary that it be regularized with the sanitary organs of the country, in other words, that it has an Operating License issued by the Local Sanitary Surveillance and Authorization of Operation of Company (AFE) granted by ANVISA. In addition, in order for a company to be legalized according to the legislation, for Health Products III and IV risk category, it is necessary to obtain the National and International GMP Certification of Manufacturing , Import and Distribution. (4)
After the due regularization of the company, all Health Products must be cadastre or registered with ANVISA. After the cadastre / registration process has been published in the Official Gazette (DOU - ANVISA Supplement), the company that holds the registration is authorized to manufacture or import and market the products in Brazil.
According to article 12 of Law n° 6.360 / 1976, no product of health interest, whether national or imported, may be industrialized, exposed to sale or delivered for consumption in the Brazilian market before being registered with the Ministry of Health. Exceptions for the products mentioned in paragraph 1, article 25 of said Law, that although exempted from registration, are subject to the Sanitary Surveillance regime by the need of the cadastre process. Failure to comply with the determinations provided for in the sanitary legislation is a violation of the Federal Sanitary Law, and the infringing Company is subject, in the administrative scope, to the penalties provided in Law 6.437/1977, without prejudice the applicable civil or criminal sanctions.
Registration and cadastre of medical products at ANVISA are governed by specific resolutions according to the nature of each product. ANVISA's rules for medical products are RDC nº 40/2015, in case of cadastre of products and RDC nº 185/2001, for those subject to registration, respectively.
The medical products subject to cadastre are those classified in classes I and II, according to RDC nº 40/2015, while the products subject to registration are those classified in Classes III and IV, as determined by RDC nº 185/2001. With respect to the latter, they may appear in any of the eighteen classification rules, according to their indication and purpose of use (example: orthopedic implants fall under Risk Classes III or IV) (5/6).
It is possible to register families of materials for medical use, including orthopedic implants. The registration process can refer to a single material (only one model in the process) or a family of materials (several models in the same process). There is no limit to the inclusion of models in the family, since all meet the requirements to be in the same family. It is possible for the company to start a family registration process with a single product, in cases where it is in the interest of registering other models in the family in question during the registration term. In this case, the Family Surveillance Surveillance Fee (TFVS) of the family should be petitioned and collected at the time of requesting the said registration, that is, at the beginning.
A process, after being published as a single product registration, can not be changed for family registration, even if the company agrees to supplement the fee later. The reverse is also not allowed. After publication as a family, the process can not be converted into a single product.
The registration request must be made by the interested company through the Petitioning System, following the steps below:
STEP 1 - COMPANY CADASTRE: Company Cadastre is the first step to gain access to the Petitioning System and should be used to cadastre private companies that provide products or services regulated by ANVISA and to cadastre users with a representation link with these Companies.
STEP 2 - AMENDMENT OF THE COMPANY'S PORT (optional): Companies should then promote the change, if necessary, of the Company's Port, which will determine the amount of fees to be paid by the interested party.
STEP 3 - PETITIONING: Before accessing the Petitioning System is recommended that the applicant identifies the Subject Code (Table 1) related to its application as it is from this source that the entire transaction request will develop. To instruct processes and petitions it is necessary to observe the mandatory documentation in the checklist in the chosen Subject Code.
The prior identification of what type of petition should be filed is a fundamental part of the beginning registration process. Knowing the relevant Subject Code for the desired purpose, as well as verifying the documents necessary for each request (checklist) accelerates the analysis of the process and avoids the technical requirements by ANVISA. Therefore, the company must verify the request in advance: 1. If the product in question is subject to cadastre or registration with ANVISA. 2. If it is possible to register material grouping in accordance with RDC n° 14/2011. 3. What materials (models, components, accessories, parts and pieces) may be included in the material registration. 4. If the product is already registered, what other petition is desired (alteration, cancellation, revalidation, transfer of ownership, addition or rectification of publication).
STEP 4 - RATES: At the end of the petitioning process will be generated Union Payment Form (GRU) for the payment of Sanitary Surveillance Inspection Fee (TFVS) related to the chosen subject. The amount of the fee is determined by Interministerial Ordinance n° 701/ 2015.
STEP 5 - PROTOCOL: After payment of the GRU, the interested party must gather all requested documentation, according to the checklist of the chosen Subject Code and submit to ANVISA, either in person or postal service .The documents forwarded to ANVISA by postal must contain the below address, knowing that no fax or copies will be accepted: À Agência Nacional de Vigilância Sanitária Diretoria ou Gerência Geral ou Gerência ou Unidade a qual se destina o documento Aos cuidados (A/C) da Gerência de Gestão Documental Referência: Número do Processo ou Expediente ou Petição, quando aplicável. Endereço: SIA, trecho 5, área especial 57 - CEP 71.205-050 - Brasília – DF
STEP 6 - ACCOMPANYING: After the application is filed, the interested party can follow the progress of their request, through the system of Consultation the Situation of Documents. For more information, see the Monitoring and Petition Queue page.
Registration and cadastre of medical products at ANVISA are governed by specific resolutions according to the nature of each product. ANVISA's rules for medical products are RDC nº 40/2015, in case of cadastre of products and RDC nº 185/2001, for those subject to registration, respectively.
The medical products subject to cadastre are those classified in classes I and II, according to RDC nº 40/2015, while the products subject to registration are those classified in Classes III and IV, as determined by RDC nº 185/2001. With respect to the latter, they may appear in any of the eighteen classification rules, according to their indication and purpose of use (example: orthopedic implants fall under Risk Classes III or IV) (5/6).
It is possible to register families of materials for medical use, including orthopedic implants. The registration process can refer to a single material (only one model in the process) or a family of materials (several models in the same process). There is no limit to the inclusion of models in the family, since all meet the requirements to be in the same family. It is possible for the company to start a family registration process with a single product, in cases where it is in the interest of registering other models in the family in question during the registration term. In this case, the Family Surveillance Surveillance Fee (TFVS) of the family should be petitioned and collected at the time of requesting the said registration, that is, at the beginning.
A process, after being published as a single product registration, can not be changed for family registration, even if the company agrees to supplement the fee later. The reverse is also not allowed. After publication as a family, the process can not be converted into a single product.
The registration request must be made by the interested company through the Petitioning System, following the steps below:
STEP 1 - COMPANY CADASTRE: Company Cadastre is the first step to gain access to the Petitioning System and should be used to cadastre private companies that provide products or services regulated by ANVISA and to cadastre users with a representation link with these Companies.
STEP 2 - AMENDMENT OF THE COMPANY'S PORT (optional): Companies should then promote the change, if necessary, of the Company's Port, which will determine the amount of fees to be paid by the interested party.
STEP 3 - PETITIONING: Before accessing the Petitioning System is recommended that the applicant identifies the Subject Code (Table 1) related to its application as it is from this source that the entire transaction request will develop. To instruct processes and petitions it is necessary to observe the mandatory documentation in the checklist in the chosen Subject Code.
Table 1: Código de Assunto
The prior identification of what type of petition should be filed is a fundamental part of the beginning registration process. Knowing the relevant Subject Code for the desired purpose, as well as verifying the documents necessary for each request (checklist) accelerates the analysis of the process and avoids the technical requirements by ANVISA. Therefore, the company must verify the request in advance: 1. If the product in question is subject to cadastre or registration with ANVISA. 2. If it is possible to register material grouping in accordance with RDC n° 14/2011. 3. What materials (models, components, accessories, parts and pieces) may be included in the material registration. 4. If the product is already registered, what other petition is desired (alteration, cancellation, revalidation, transfer of ownership, addition or rectification of publication).
STEP 4 - RATES: At the end of the petitioning process will be generated Union Payment Form (GRU) for the payment of Sanitary Surveillance Inspection Fee (TFVS) related to the chosen subject. The amount of the fee is determined by Interministerial Ordinance n° 701/ 2015.
STEP 5 - PROTOCOL: After payment of the GRU, the interested party must gather all requested documentation, according to the checklist of the chosen Subject Code and submit to ANVISA, either in person or postal service .The documents forwarded to ANVISA by postal must contain the below address, knowing that no fax or copies will be accepted: À Agência Nacional de Vigilância Sanitária Diretoria ou Gerência Geral ou Gerência ou Unidade a qual se destina o documento Aos cuidados (A/C) da Gerência de Gestão Documental Referência: Número do Processo ou Expediente ou Petição, quando aplicável. Endereço: SIA, trecho 5, área especial 57 - CEP 71.205-050 - Brasília – DF
STEP 6 - ACCOMPANYING: After the application is filed, the interested party can follow the progress of their request, through the system of Consultation the Situation of Documents. For more information, see the Monitoring and Petition Queue page.
Figure 2 – Registration Flow of Health Products/Medical Products at ANVISA
3. Conclusion
The ANVISA`s activity, in the area of health products occurs through various health control strategies. One of these is the cadastre and registration of these products. In addition, rules are laid down to establish standards for assurance the quality and safety of products. Beyond that, in conjunction with states and municipalities, inspections are conducted at manufacturers and distributors, focusing on the evaluation of good production practices.
The correct interpretation by the regulated sector of the resolutions regarding the cadastre and registration of health products or medical products in ANVISA is fundamental for the agile progress of the process. The processes with loss, erroneous or incomplete informations have their time of analysis increased as a result of technical requirements by ANVISA, which aim at the adequacy of the process to the current sanitary legislation, leading to delays in the launch of products on the market and availability to the population.
The correct interpretation by the regulated sector of the resolutions regarding the cadastre and registration of health products or medical products in ANVISA is fundamental for the agile progress of the process. The processes with loss, erroneous or incomplete informations have their time of analysis increased as a result of technical requirements by ANVISA, which aim at the adequacy of the process to the current sanitary legislation, leading to delays in the launch of products on the market and availability to the population.
References :
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Brasil possui forte presença no mercado de produtos médicos. Available at http://www.brasil.gov.br/economia-e-emprego/2014/11/brasil-possui-forte-presenca-no-mercado-de-produtos-medicos. Accessed in: 03/03/2017
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Inovação e Excelência. Available at http://abimed.org.br/noticias/inovacao-e-excelencia. Accessed in: 03/03/2017
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Mercado de produtos e equipamentos médicos encolhe 16% no semestre. Available at http://saudebusiness.com/noticias/mercado-de-produtos-e-equipamentos-medicos-encolhe-16-no-semestre/. Accessed in: 03/03/2017
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Regularização de Produtos - Materiais de uso em Saúde - Registro de Produtos. Available at http://portal.ANVISA.gov.br/registros-e-autorizacoes/produtos-para-a-saude/produtos/registro. Accessed in: 03/03/2017
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ANVISA, Manual para Regularização de Equipamentos Médicos na ANVISA, 2010.
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ANVISA, Guia Nº 06/2016, Versão 2 - Guia Orientativo para o Dossiê Técnico do Cadastro de Produtos Médicos: RDC nº 40, de 27 de agosto de 2015.
Profile :
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NOGUCHI, Vera Working at Vital Brazil Institute as Quality Assurance and Regulatory Affairs Manager
Contact: E-mail: veranoguchi@hotmail.com; garantiadaqualidade.ivb@gmail.com
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