Medical Device - ANVISA regulation in Brazil
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Brazil International Ltd. is a boutique company that provides business services for companies in the medical device field, seeking to successfully penetrate and participate in the Brazilian market.
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The document discusses regulations for medical devices in Brazil, including the country's healthcare system and regulatory approval process. It outlines key steps such as classification, appointing a Brazilian registration holder, ANVISA GMP inspection, INMETRO certification, and ANVISA registration. The lengthy overall process and importance of understanding regulatory changes and working with a local partner are emphasized.
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This document provides information about ANVISA, the National Health Surveillance Agency of Brazil. Some key points:
- ANVISA is the regulatory body that oversees pharmaceuticals, cosmetics, medical devices and other health products in Brazil. It was established in 1999.
- ANVISA's mission is to protect and promote public health by ensuring safety and quality standards for products and services.
- It is responsible for monitoring drug prices, medical device approval, tobacco control and more. ANVISA works with the Brazilian Ministry of Health.
- Detailed guidelines are provided around the registration of new drugs, generic drugs, medical devices and other regulated products in Brazil according to ANVISA's
ANVISA
ANVISA is the Brazilian Health Surveillance Agency that regulates health products and services. It oversees the registration, labeling, and safety monitoring of drugs, medical devices, cosmetics, food, and other products. ANVISA also regulates blood and tissue donation, health services, pesticides, and tobacco. It aims to protect public health through rules, inspections, and international cooperation.
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Distributor Search; Market Research; Business Development
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The National Health Surveillance Agency (ANVISA) was established in 1999 in Brazil to coordinate various national health programs and oversee sanitary control and surveillance. ANVISA monitors drug prices, medical devices, tobacco products and more. It aims to protect public health by regulating products and services subject to health oversight. ANVISA is part of the National System of Sanitary Surveillance, which works to inspect professional activities and places that handle food and more. ANVISA's responsibilities include oversight of areas like blood, cosmetics, drugs, food, laboratories and more to help ensure health and safety.
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The document discusses regulations for medical devices in Brazil, including the country's healthcare system and regulatory approval process. It outlines key steps such as classification, appointing a Brazilian registration holder, ANVISA GMP inspection, INMETRO certification, and ANVISA registration. The lengthy overall process and importance of understanding regulatory changes and working with a local partner are emphasized.
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This document provides information about ANVISA, the National Health Surveillance Agency of Brazil. Some key points:
- ANVISA is the regulatory body that oversees pharmaceuticals, cosmetics, medical devices and other health products in Brazil. It was established in 1999.
- ANVISA's mission is to protect and promote public health by ensuring safety and quality standards for products and services.
- It is responsible for monitoring drug prices, medical device approval, tobacco control and more. ANVISA works with the Brazilian Ministry of Health.
- Detailed guidelines are provided around the registration of new drugs, generic drugs, medical devices and other regulated products in Brazil according to ANVISA's
ANVISA
ANVISA is the Brazilian Health Surveillance Agency that regulates health products and services. It oversees the registration, labeling, and safety monitoring of drugs, medical devices, cosmetics, food, and other products. ANVISA also regulates blood and tissue donation, health services, pesticides, and tobacco. It aims to protect public health through rules, inspections, and international cooperation.
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Product Registration; License Holding
GMP Certification; Quality Assurance
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Distributor Search; Market Research; Business Development
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Anvisa
The National Health Surveillance Agency (ANVISA) was established in 1999 in Brazil to coordinate various national health programs and oversee sanitary control and surveillance. ANVISA monitors drug prices, medical devices, tobacco products and more. It aims to protect public health by regulating products and services subject to health oversight. ANVISA is part of the National System of Sanitary Surveillance, which works to inspect professional activities and places that handle food and more. ANVISA's responsibilities include oversight of areas like blood, cosmetics, drugs, food, laboratories and more to help ensure health and safety.
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Health services and products are the most stringently regulated in the world.
The current regulation represents the distilled wisdom of past experiences.
Having safe and quality products and services is a corner stone for public health
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EFMHACA is a federal science based law enforcement authority mandated to protect the public health and safety
Established by Council of Ministers Regulation No. 189/2010
Established as an autonomous government office having its own legal personality
Accountable to Ministry of Health
Head office at Addis Ababa and may have branch office else where, as may be necessary
Objectives
To protect the health of consumers by ensuring:
Food safety and quality
Safety, efficacy, quality and proper use of medicines
Competence and ethics of health professionals
The standards of health institution and
The hygiene and environmental health protection suitability for individuals and community health
Mission Statement
To promote and protect the public health by ensuring safety and quality of products and health service through
registration, licensing and inspection of health professionals, pharmaceuticals & food establishments, and health facilities and
provision of up-to-date regulatory information
promoting rational medicines use
Organized regulation started since 1960s
Health Sector Reform [in 2008]; which scrutinizes all regulatory components together
Mandate were divided into [in 2009)
Federal regulatory body
Regional regulatory bodies
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Drap afsheen.2
Contents:
History
DRAP
Composition of DRAP
Function of DRAP
Policy board
Funds and budget of DRAP
Real picture of DRAP
Other agencies
References
History Of Authorities
What Is Drug Regulatory Authority
Drug Regulatory Authority of Pakistan (DRAP) has been established in NOV13,2012 for effective coordination and enforcement of the Drugs Act, 1976.
The Drug Regulatory Authority of Pakistan (DRAP) is an autonomous body working under the administrative control of Ministry of National Health Services.
The Authority is expected to regulate, manufacture, import, export, storage, distribution and sale of therapeutic goods.
What Is Drug Regulatory Authority,…
The authority may set up its establishments including sub-offices and laboratories at province capital and such other places from time to time.
The existing Federal Drug Control Administration(FDCA) and sub offices set up in all provinces are called Central Drug Laboratory
For example;
National Control Laboratory on Biological, Karachi
Federal Drug Surveillance Laboratory, Islamabad
Composition Of DRAP
Chief executive officer
Director Pharmaceutical Evaluations and Registration
Director Drug Licensing
Director Quality Assurance and Laboratory Testing
Director Medical Devices and Medicated Cosmetics
Director Biological Drugs
Composition Of DRAP,….
Director Controlled Drugs
Director Health and OTC Products (non-drugs)
Director Costing and Pricing
Director Budget and Accounts
Director Administration, Human Resource and Logistics
Director Legal Affairs
Director Management Information Services
Power And Function Of DRAP
Evaluation and Registration of pharmaceutical drugs, medical devices and medicated cosmetics, alternative medicines And Licensing of Drug Manufacturing facilities.
Regulation of controlled drugs and biological drugs.
Policy board
DRA will work under the Policy board which consists of 15 members.
Chair person of Board will be Secretary of Federal Health Division
Members will consist of Chief Executive of Agency, Health Secretary of all provinces.
Functions of policy board
Monitor and supervise all function of the DRAP.
Approve the budget of the DRAP.
Determine all fees and leaves.
Funds And Budgets
Loans and grants from the national and international agencies received by the federal government and provincial government to finance the function of the authority.
Grat-in aid in term of salaries and retirements benefits of the existing staff provided by the federal government.
Charges and fees collected by the authority to recover the cost of regulated activities
Funds And Budgets……………
Central research fund collected from pharmaceutical industry.
The authority shall, in respect of each financial year prepare an annual budget for approval from board and shall sent to the federal government for appropriate provision and allocation.
Facts About DRAP
Dr Hussein, regional
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Drap afsheen.2
Contents:
History
DRAP
Composition of DRAP
Function of DRAP
Policy board
Funds and budget of DRAP
Real picture of DRAP
Other agencies
References
History Of Authorities
What Is Drug Regulatory Authority
Drug Regulatory Authority of Pakistan (DRAP) has been established in NOV13,2012 for effective coordination and enforcement of the Drugs Act, 1976.
The Drug Regulatory Authority of Pakistan (DRAP) is an autonomous body working under the administrative control of Ministry of National Health Services.
The Authority is expected to regulate, manufacture, import, export, storage, distribution and sale of therapeutic goods.
What Is Drug Regulatory Authority,…
The authority may set up its establishments including sub-offices and laboratories at province capital and such other places from time to time.
The existing Federal Drug Control Administration(FDCA) and sub offices set up in all provinces are called Central Drug Laboratory
For example;
National Control Laboratory on Biological, Karachi
Federal Drug Surveillance Laboratory, Islamabad
Composition Of DRAP
Chief executive officer
Director Pharmaceutical Evaluations and Registration
Director Drug Licensing
Director Quality Assurance and Laboratory Testing
Director Medical Devices and Medicated Cosmetics
Director Biological Drugs
Composition Of DRAP,….
Director Controlled Drugs
Director Health and OTC Products (non-drugs)
Director Costing and Pricing
Director Budget and Accounts
Director Administration, Human Resource and Logistics
Director Legal Affairs
Director Management Information Services
Power And Function Of DRAP
Evaluation and Registration of pharmaceutical drugs, medical devices and medicated cosmetics, alternative medicines And Licensing of Drug Manufacturing facilities.
Regulation of controlled drugs and biological drugs.
Policy board
DRA will work under the Policy board which consists of 15 members.
Chair person of Board will be Secretary of Federal Health Division
Members will consist of Chief Executive of Agency, Health Secretary of all provinces.
Functions of policy board
Monitor and supervise all function of the DRAP.
Approve the budget of the DRAP.
Determine all fees and leaves.
Funds And Budgets
Loans and grants from the national and international agencies received by the federal government and provincial government to finance the function of the authority.
Grat-in aid in term of salaries and retirements benefits of the existing staff provided by the federal government.
Charges and fees collected by the authority to recover the cost of regulated activities
Funds And Budgets……………
Central research fund collected from pharmaceutical industry.
The authority shall, in respect of each financial year prepare an annual budget for approval from board and shall sent to the federal government for appropriate provision and allocation.
Facts About DRAP
Dr Hussein, regional
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This document provides an overview of the administration of the Drugs and Cosmetics Act and Rules in India. It discusses the roles of various analytical, executive, and advisory bodies involved in drug regulation. It also outlines the qualifications, duties, and powers of key regulatory positions like Government Analysts, Drugs Inspectors, and the procedures they follow to inspect facilities, collect samples, test drugs, and take action if drugs are found to be substandard.
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This Powerpoint covers the most Frequently asked Questions in Pharmaceutical Jurisprudence for Pharmacy Students.
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ANVISA is the Brazilian Health Surveillance Agency established in 1999 to coordinate the National Sanitary Surveillance System and other health programs. It is responsible for regulating drugs, medical devices, food, cosmetics and other products. ANVISA monitors prices, conducts inspections, and provides technical support. It aims to protect public health through sanitary control of production, marketing and borders. ANVISA is part of the decentralized National System of Sanitary Surveillance and works with various federal, state and municipal agencies.
ANVISA regulatory authority of brazil
ANVISA is the regulatory body for health surveillance in Brazil. It was established in 1999 to protect public health by regulating products and services under health surveillance. ANVISA's mission is to protect and promote health by ensuring hygiene, safety of products and services, and facilitating access. The agency is responsible for surveillance of areas like drugs, cosmetics, food, medical devices, and more. It coordinates the National Health Surveillance System and establishes standards. ANVISA's website provides information on regulations, registered products, permits and more.
Japan PMDA Medical Device Regulatory Approval Process
Watch the recorded webinar: https://www.emergogroup.com/resources/video-webinar-japan-registration-process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
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WATCH the recorded webinar here: http://www.emergogroup.com/resources/video-webinar-europe-mdr-changes
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The Japanese market for medical devices reached $37.6 billion in 2016 and is expected to grow to $45 billion by 2020, making it the second largest market globally in terms of growth rate. It remains heavily reliant on imports, especially for sophisticated devices. The regulatory agencies overseeing the medical device market in Japan are the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labor and Welfare (MHLW). Devices are classified based on risk into four classes, with Class I having the lowest risk and Class IV the highest. Regulatory approval processes differ depending on the class, ranging from self-declaration for Class I devices to pre-market approval from MHLW for Class III and
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The document discusses conducting clinical trials in Latin America. It provides an overview of key considerations for investigators, sites, patients, the regulatory environment, and common challenges and suggestions for success. Specific topics covered include investigator experience and training, public vs private sites and locations, patient standards of care, epidemiology, regulatory timelines and processes, informed consent requirements, and regional requirements regarding comparators and continued treatment.
Clinical Trials Latin America Oct 2010 1
Latin America provides opportunities for clinical research due to its large, diverse population concentrated in major cities. The region has two main languages and a growing pharmaceutical market projected to reach $80 billion by 2013. Countries like Brazil, Argentina, and Chile form the large Southern Cone market and have quality clinical research environments with experienced regulators following ICH-GCP guidelines. However, some challenges remain like improving ethics review, dedicated research infrastructure, and lengthy government approval processes. Overall, Latin America's lower costs and unique patient populations make it an attractive region for recruitment in clinical trials.
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The document summarizes recent developments regarding compliance with regulations on interactions between the medical device industry and healthcare professionals in the Netherlands. Specifically, it discusses:
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Taiwan medical device registration and approval chart - EMERGO
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Drug registration in Mexico
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Brazil medical device registration and approval chart - EMERGO
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Medical Device - ANVISA regulation in Brazil
- 1. Brazil and more
- 2. Latin America Total population : 590,086,590 Pop. Density : 27 per sq/km Total countries : 20 Dependencies : 10 Language : Spanish, Portuguese Time zone : UTC -2 to UTC -8
- 3. Latin America GDP Brazil $2,181,677
- 4. Why Brazil?!
- 8. ANVISA Was established in January 26th 1999 with the purpose to foster protection the health of the population by regulating, controlling and inspecting products and services in the medical device field, drugs, cosmetics, food and tobacco. Sanitary control over production and marketing of products and services subject to sanitary surveillance. To authorize the operation of manufacturing, distribution and importing firms. To grant and to withdraw certificates of good manufacturing practice; GMP.
- 9. Regulatory Alternatives Company Incorporation Brazil Assemble local GMP in Brazil Register ANVISA submit paperwork for ANVISA 24-36 Months 24 Months 6-8 Months Mfg. local GMP in Israel Inspection GMP and INMETRO if needed
- 11. Why us? Quality We make it better Partnership We make it together Accessibility We make it accessible Efficiency We make it happen
- 16. Our state of the art site in Ribeirão Preto , Brazil, built with the highest standards of ANVISA and includes sterile rooms, assembly line, warehouse and offices .
- 17. Your Private Office in South America An option of establishing a marketing and distribution local center, including the employment of a regional sales manager at customer’s direct management and supervision, as part of our infrastructure in Brazil. Reducing marketing expenses. Local business culture. Real-time marketing.