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Medical Device Regulatory in Asia_Brazil

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M
May Ng ARQon l Asia Regulatory and Quality Consultancy

For more information: Email: info@arqon.com LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs Twitter: @ARQonSG Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam -ARQon Service- ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World. ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals EUROPE - Notified Bodies Approval MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals

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Asia Regulatory & Quality Consultancy for Medical Device & Drug Overview Regulatory Process ConclusionLicensingCosts Regulatory of MD & IVD in Brazil National Health Surveillance Agency (ANVISA) I IVIIIII Lowest Risk Highest RiskMedium-High Risk Low-Medium Risk Requires BGMP Certificate
Overview Regulatory Process ConclusionLicensingCosts Regulatory of MD & IVD in Brazil Asia Regulatory & Quality Consultancy for Medical Device & Drug Cadastro: Registro: Class I and Class II Class III and Class IV 1. Submit technical documents (including authorisation letter) 2. Review of documents/Elaboration of process 3. Payment to ANVISA 4. Submit documents 5. ANVISA evaluation 6. Product registration 1. Submit technical documents (including authorisation letter & free sale certificate) 2. Review of documents/Elaboration of process 3. Payment to ANVISA 4. Submit documents 5. ANVISA evaluation 6. Product registration 2 to 4 months 12 to 24 months
Overview ConclusionCostsRegulatory Process Licensing Regulatory of MD & IVD in Brazil Asia Regulatory & Quality Consultancy for Medical Device & Drug I IVIIIII $100 USD $250 USD$200 USD$150 USD *Application (ANVISA) fees vary according to the holder company size. The above fees refer to micro-enterprise $20,000 USD BGMP Certification fee
Overview ConclusionCostsRegulatory Process Licensing Regulatory of MD & IVD in Brazil Asia Regulatory & Quality Consultancy for Medical Device & Drug Registration & Licensing: • Registration has to be done by a Local License Holder. • License can be transferred upon agreement from the current License Holder. • License Holder can authorize, through an Authorisation Letter, the importation of products by multiple distributors according to the manufacturer’s choice • To qualify as an importer/distributor some documents/licenses are required, such as AFE
Overview ConclusionRegulatory Process LicensingCosts Regulatory of MD & IVD in Brazil Asia Regulatory & Quality Consultancy for Medical Device & Drug • There are 2 types of product registration route: o Cadastro for lower risk devices o Registro for higher risk devices • Higher risk devices require a previous GMP certification and also more detailed information before approval
Overview Conclusion Contact us for details info@arqon.com www.arqon.com Asia Regulatory & Quality Consultancy for Medical Device & Drug @ARQonSG Regulatory Process LicensingCosts Regulatory of MD & IVD in Brazil

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Medical Device Regulatory in Asia_Brazil

  • 1.
  • 2. Asia Regulatory & Quality Consultancy for Medical Device & Drug Overview Regulatory Process ConclusionLicensingCosts Regulatory of MD & IVD in Brazil National Health Surveillance Agency (ANVISA) I IVIIIII Lowest Risk Highest RiskMedium-High Risk Low-Medium Risk Requires BGMP Certificate
  • 3. Overview Regulatory Process ConclusionLicensingCosts Regulatory of MD & IVD in Brazil Asia Regulatory & Quality Consultancy for Medical Device & Drug Cadastro: Registro: Class I and Class II Class III and Class IV 1. Submit technical documents (including authorisation letter) 2. Review of documents/Elaboration of process 3. Payment to ANVISA 4. Submit documents 5. ANVISA evaluation 6. Product registration 1. Submit technical documents (including authorisation letter & free sale certificate) 2. Review of documents/Elaboration of process 3. Payment to ANVISA 4. Submit documents 5. ANVISA evaluation 6. Product registration 2 to 4 months 12 to 24 months
  • 4. Overview ConclusionCostsRegulatory Process Licensing Regulatory of MD & IVD in Brazil Asia Regulatory & Quality Consultancy for Medical Device & Drug I IVIIIII $100 USD $250 USD$200 USD$150 USD *Application (ANVISA) fees vary according to the holder company size. The above fees refer to micro-enterprise $20,000 USD BGMP Certification fee
  • 5. Overview ConclusionCostsRegulatory Process Licensing Regulatory of MD & IVD in Brazil Asia Regulatory & Quality Consultancy for Medical Device & Drug Registration & Licensing: • Registration has to be done by a Local License Holder. • License can be transferred upon agreement from the current License Holder. • License Holder can authorize, through an Authorisation Letter, the importation of products by multiple distributors according to the manufacturer’s choice • To qualify as an importer/distributor some documents/licenses are required, such as AFE
  • 6. Overview ConclusionRegulatory Process LicensingCosts Regulatory of MD & IVD in Brazil Asia Regulatory & Quality Consultancy for Medical Device & Drug • There are 2 types of product registration route: o Cadastro for lower risk devices o Registro for higher risk devices • Higher risk devices require a previous GMP certification and also more detailed information before approval
  • 7. Overview Conclusion Contact us for details info@arqon.com www.arqon.com Asia Regulatory & Quality Consultancy for Medical Device & Drug @ARQonSG Regulatory Process LicensingCosts Regulatory of MD & IVD in Brazil

Notes de l'éditeur

  1. In this video, we are going to talk about the regulations for medical devices in Brazil. Medical devices in Brazil are classified according to their risk levels, where Class I possesses the lowest risk, and Class IV posses the highest risk. BGMP certificate is required for both local and foreign manufacturers with Class III and IV medical devices. This can be obtained after an audit performed by ANVISA.
  2. There are two registration routes. The “Cadastro” registration is for lower risk devices and has a simplified application. The “Registro” registration is for higher risk medical devices, has a more complex application and typically takes more time and is more costly than Cadastro. As mentioned previously, devices under Registro registration route also requires BGMP certification. They require more detailed information from the technical file, including clinical data and evaluation.
  3. The application fees and time estimated for each classes are reflected here. The cost may vary according to the holder company size.
  4. You have to be a Brazilian company to qualify as a license holder. The license holder can authorize through an authorisation letter, the importation of products by distributors according to the manufacturer’s choice. Documents/licenses required such as AFE is needed in order to qualify as an importer/distributor.
  5. To summarise, there are 2 product registration routes in Brazil; Cadastro for the lower risk and Registro for the higher risk devices. The higher risk medical devices requires more detailed technical documents and GMP certification to obtain approval before importing and supplying into Brazil. If you are looking to gain fast approval for your medical devices in Brazil, ARQon can help to register and obtain approval for your products.
  6. Should you require more information, do contact us at info@arqon.com or visit our website www.arqon.com for more details, and follow us on LinkedIn and Twitter for regular updates on regulatory and quality news on Medical Devices.