regulatory and policy updates anvisa
play

Regulatory and Policy Updates ANVISA Leandro Rodrigues Pereira - PowerPoint PPT Presentation

Feb 26, 2024 •159 likes •244 views

Regulatory and Policy Updates ANVISA Leandro Rodrigues Pereira General Manager Medical Devices Office Regulatory Updates Resolution RDC n 270/2019 - Simplification of the regulatory process for the lowest-risk medical devices.

  1. Regulatory and Policy Updates ANVISA Leandro Rodrigues Pereira General Manager Medical Devices Office

  2. Regulatory Updates • Resolution RDC n° 270/2019 - Simplification of the regulatory process for the lowest-risk medical devices. • Regulatory process for Class I devices (including IVDs) change from cadastro (simplified approval) to a simple notification. • Effective on 05/02/2019. 2

  3. Regulatory Updates • Public Consultation n° 546/2018 - Regulations for custom-made devices • Core elements of the Public Consultation: • Device manufacturers and importers must be fully licensed by ANVISA; • Manufacturers of Class III and IV devices must have valid Brazilian Good Manufacturing Practice (BGMP) certifications 3

  4. Regulatory Updates • Public Consultation n° 584/2018; 584/2018 and 586/2018 – Updates requirements for Reprocessing & Reuse of Medical Devices. • Requirements for labeling and for good practices for the processing Medical Devices; • Anvisa’s goal with the proposal of a new RDC is to improve the management of risks associated with the processing of medical devices. 4

  5. Regulatory Updates • Public Consultations How to submit your contribution? http://portal.anvisa.gov.br/consultas-publicas#/ You can also upload documents, such as position papers and send it to ANVISA. 5

  6. 6

  7. MDSAP Certification 2019 Increasement Projection: 30% to 40% of the total GMP Certification to be issued by Anvisa. 7

  8. Thank you! Leandro Rodrigues Pereira General Manager Medical Devices Office ANVISA 8

Recommend

Regulatory and Policy Updates ANVISA Leandro Rodrigues Pereira General Manager Medical Devices

Regulatory and Policy Updates ANVISA Leandro Rodrigues Pereira General Manager Medical Devices

Regulatory and Policy Updates ANVISA Leandro Rodrigues Pereira General Manager Medical Devices Office Regulatory Updates ANVISA has launched the National Implant Registry (RNI). The online system will initially collect voluntary

652 views • 9 slides
REGULATORY UPDATES IMDRF Stakeholders Meeting Braslia, Brazil, March 2016 ANVISA Brazil

REGULATORY UPDATES IMDRF Stakeholders Meeting Braslia, Brazil, March 2016 ANVISA Brazil

REGULATORY UPDATES IMDRF Stakeholders Meeting Braslia, Brazil, March 2016 ANVISA Brazil Regulatory Updates Resolution ANVISA Normative Instruction n 04 (24/09/2015) - Update of technical standards (ISO/IEC) regarding mandatory

473 views • 8 slides
REGULATORY UPDATES IMDRF Stakeholders Meeting Ottawa, Canada, September 2017 ANVISA Brazil

REGULATORY UPDATES IMDRF Stakeholders Meeting Ottawa, Canada, September 2017 ANVISA Brazil

REGULATORY UPDATES IMDRF Stakeholders Meeting Ottawa, Canada, September 2017 ANVISA Brazil Minamata Convention Resolution RDC 147/17 Establishes a phase out date for clinical thermometers and sphygmomanometers containing mercury.

417 views • 7 slides
REGULATORY UPDATE IMDRF Stakeholders Meeting Tokyo, Japan, March 2015 ANVISA Brazil

REGULATORY UPDATE IMDRF Stakeholders Meeting Tokyo, Japan, March 2015 ANVISA Brazil

REGULATORY UPDATE IMDRF Stakeholders Meeting Tokyo, Japan, March 2015 ANVISA Brazil REGULATORY UPDATE ANVISA Normative Instruction n11/2014 Update of technical standards (ISO) regarding mandatory certification of electromedical

509 views • 9 slides
Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Kimby N. Barton

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Kimby N. Barton

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Kimby N. Barton Interim Director Medical Devices Bureau Overview Changes to: Policy Regulatory Transparency and Openness Guidance 2 Policy

384 views • 10 slides
regulatory aspects on medical devices ANVISA IMDRF Management Committee Meeting March 19 21,

regulatory aspects on medical devices ANVISA IMDRF Management Committee Meeting March 19 21,

Update on the Brazilian regulatory aspects on medical devices ANVISA IMDRF Management Committee Meeting March 19 21, 2013 Basis for the regulation on medical devices Law N. 6.360/1976 and Decree N. 79.094/1977 These norms set the basis for

279 views • 9 slides
Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Carey Agnew

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Carey Agnew

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Carey Agnew A/Director Medical Devices Bureau Policy Medical Device Single Audit (MDSAP) Transition Plan published December 4, 2015 January 1, 2017-

391 views • 5 slides
Regulatory and Policy Updates Therapeutic Products Directorate Health Canada David Boudreau

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada David Boudreau

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada David Boudreau Executive Director Medical Devices Bureau Overview Medical Device Single Audit Program (MDSAP) Regulatory Review of Drugs and Devices

292 views • 13 slides
Regulatory and Policy Updates Therapeutic Products Directorate Health Canada David Boudreau

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada David Boudreau

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada David Boudreau Executive Director Medical Devices Bureau Overview Medical Device Single Audit Program (MDSAP) Scientific Advisory Committee on Digital

562 views • 11 slides
Update on the Brazilian regulatory aspects on medical devices ANVISA Brazil Basis for the

Update on the Brazilian regulatory aspects on medical devices ANVISA Brazil Basis for the

Update on the Brazilian regulatory aspects on medical devices ANVISA Brazil Basis for the regulation on medical devices - Law N. 6.360/1976 - basis for regulation of all products under health surveillance in Brazil, including medical devices.

473 views • 8 slides
Regulatory Updates (NRC 2013) TAN ANN LING DIRECTOR OF REGULATORY PHARMACY Certified to ISO WHO

Regulatory Updates (NRC 2013) TAN ANN LING DIRECTOR OF REGULATORY PHARMACY Certified to ISO WHO

Regulatory Updates (NRC 2013) TAN ANN LING DIRECTOR OF REGULATORY PHARMACY Certified to ISO WHO Collaborating Centre Member of Pharmaceutical 9001:2008 for Regulatory Control of Inspection Co-operation Scheme Cert. No.: AR 2293

521 views • 37 slides
Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Cindy Evans

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Cindy Evans

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Cindy Evans Interim Senior Executive Director, Therapeutics Product Directorate Re-Use of Single Use Devices In February 2015, Health Canada announced its

83 views • 5 slides
REGULATORY APPROVALS IN BRAZIL TRENDS AND REGULATORY UPDATES & BEST PRACTICES: A

REGULATORY APPROVALS IN BRAZIL TRENDS AND REGULATORY UPDATES & BEST PRACTICES: A

REGULATORY APPROVALS IN BRAZIL TRENDS AND REGULATORY UPDATES & BEST PRACTICES: A perspective straight from the in-country labs 2014 IEEE Symposium Product Compliance Engineering Elizabeth Perrier, MTM, PMP San Jose, California May 5th,

847 views • 82 slides
Ease of Doing Business f i i Key Policy and Regulatory Developments Key Policy and Regulatory

Ease of Doing Business f i i Key Policy and Regulatory Developments Key Policy and Regulatory

Ease of Doing Business f i i Key Policy and Regulatory Developments Key Policy and Regulatory Developments R. Sampath Kumar New Delhi June 2015 The contents of this document are confidential Overview Plans announced and steps taken to

496 views • 14 slides
Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Cindy Evans

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Cindy Evans

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada Cindy Evans Director, Medical Devices Bureau Non-Corrective (NC) Contact Lenses Bill C-313, An Act to Amend the Food and Drugs Act (non-corrective contact lenses)

360 views • 11 slides
OFFICE OF REGULATORY AFFAIRS OFFICE OF REGULATORY SCIENCE Updates and Areas of Collaboration with

OFFICE OF REGULATORY AFFAIRS OFFICE OF REGULATORY SCIENCE Updates and Areas of Collaboration with

OFFICE OF REGULATORY AFFAIRS OFFICE OF REGULATORY SCIENCE Updates and Areas of Collaboration with NCTR Sean W. Linder, Ph.D. 1 www.fda.gov ORA Roles & Responsibilities Inspections of firms and plants producing FDA-regulated products

415 views • 12 slides
Regulatory updates from the Complementary and OTC Medicines Branch Listed medicines regulatory

Regulatory updates from the Complementary and OTC Medicines Branch Listed medicines regulatory

Regulatory updates from the Complementary and OTC Medicines Branch Listed medicines regulatory reforms Michael Shum Director, Business Improvement and Support Section Complementary and OTC Medicines Branch 2019 ARCS Annual Conference 6 August

796 views • 43 slides
TEC Roadshow 2016 Welcome Our agenda this afternoon: Tertiary Policy updates SDR

TEC Roadshow 2016 Welcome Our agenda this afternoon: Tertiary Policy updates SDR

TEC Roadshow 2016 Welcome Our agenda this afternoon: Tertiary Policy updates SDR technical updates Ministry of Education TEC Sector Helpdesk updates NZQA and Education New Zealand Studylink updates Tertiary Policy Updates

905 views • 71 slides
Helping Emerging Managers Regulatory Updates, Financial Reporting and Industry Trends Regulatory

Helping Emerging Managers Regulatory Updates, Financial Reporting and Industry Trends Regulatory

Helping Emerging Managers Regulatory Updates, Financial Reporting and Industry Trends Regulatory Update 2 Deloitte PowerPoint timesaver August 2011 SEC Registration Registration New rules effective March 31, 2012 replacing SECs

179 views • 17 slides
Emerging Policy, Regulatory, Emerging Policy, Regulatory, Business and Technical Trends Business

Emerging Policy, Regulatory, Emerging Policy, Regulatory, Business and Technical Trends Business

Emerging Policy, Regulatory, Emerging Policy, Regulatory, Business and Technical Trends Business and Technical Trends Syed Ismail Shah, PhD Chairman, PTA and Contact: ismail@pta.gov.pk Vision of PTA: Create a fair regulatory regime to promote

343 views • 18 slides
Daniel Trnka and Rebecca Schultz, Regulatory Policy, OECD NNR Better Regulation Seminar 27 March

Daniel Trnka and Rebecca Schultz, Regulatory Policy, OECD NNR Better Regulation Seminar 27 March

OECD REGULATORY POLICY OUTLOOK 2018 Daniel Trnka and Rebecca Schultz, Regulatory Policy, OECD NNR Better Regulation Seminar 27 March 2019, Stockholm OECD and Regulatory Policy 25 years of experience in dealing with regulatory

184 views • 16 slides
Agenda Welcome & Introductions National and Commonwealth Updates Policy Updates

Agenda Welcome & Introductions National and Commonwealth Updates Policy Updates

Creating A Clean, Affordable and Resilient Energy Future For the Commonwealth Leading by Example Council Meeting September 12, 2017 Agenda Welcome & Introductions National and Commonwealth Updates Policy Updates Guest Speaker:

1.08k views • 59 slides
Governance Nick Malyshev Head, Regulatory Policy Division OECD Why are OECD countries focusing

Governance Nick Malyshev Head, Regulatory Policy Division OECD Why are OECD countries focusing

The Right Time to Focus on Regulatory Reform in Vietnam OECD Work on Regulatory Policy and Governance Nick Malyshev Head, Regulatory Policy Division OECD Why are OECD countries focusing on regulatory reforms? Possibilities of monetary

477 views • 21 slides
Focused Assessment Program Overview and Updates Office of International Trade Regulatory Audit

Focused Assessment Program Overview and Updates Office of International Trade Regulatory Audit

Focused Assessment Program Overview and Updates Office of International Trade Regulatory Audit October 2, 2014 Who is Regulatory Audit? Regulatory Audits (RAs) mission is to conduct post- entry audits of importers and other private

813 views • 41 slides

More recommend