Distributor meeting Regulatory aspects.

Slides:

Advertisements

Similar presentations

1 Non-Tariff Measures Technical regulations (requirements) Conformity assessment procedures Administrative procedures.

Advertisements

Regulatory Auditing. Audit Areas Management Responsibility Auditing (internal and external) Design Control Document Control Purchasing Control Identification.

Risk Management in Regulatory Systems An Introductory Webinar.

WP4 – Task 4.4 LCA Activities

REACH and SDS Requirements Presented by Paula Laux Senior Regulatory Specialist Wercs Professional Services.

Options for Regulation and the Impact of Regulation on the Marketplace 29 November 2005 Alan Kent

Hogan Lovells EU Product Safety and Market Surveillance Reforms How will this impact businesses – Lawyers' view BIICL seminar, 2 October.

CE marking Catriona Blake Team Manager, Imaging, acute and community care.

Classification of HLA Devices FDA Introduction & Background Sheryl A. Kochman CBER/OBRR/DBA.

Overview of Medical Devices Sector Saudi Food and Drug Authority (Saudi Arabia) Dr. Saleh Al Tayyar Director General Medical Devices Sector Saudi Food.

DRAFT Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing Denise Sánchez, J.D.,

Q&A REGULATORY AFFAIRS IN LATIN AMERICA. DEFINITION OF MEDICAL DEVICE Product, equipment, device, material, article or system of Medical, Odontological.

Regulatory Overview.

Some points of view about Chapters 3 and 4 Grundtvig project

U D T Workshop on the Pressure Equipment Directive, Warsaw June 2004 INTERFACES BETWEEN NATIONAL LEGISLATION AND DIRECTIVE 97/23/EC SYSTEM OF ENSURING.

FORMS AND ORDER OF REALIZATION OF CUSTOM CONTROL(CC)

Telecommunications Customer Equipment Compliance & Labelling Peter Cunningham Standards Section ITP 2006.

1 Certification of Community Origin Presenter Bernard Black Senior Project Officer – Customs & Trade Policy CARICOM Secretariat.

1 CONSENSUS STANDARDS OIVD WORKSHOP April 22-23, 2003 Rockville MD Ginette Y. Michaud, M.D. OIVD.

GCP & ETHICS COMMITTEES Ravi Rengachari Vector Control Research Centre PONDICHERRY.

© Siemens AG 2014 Alle Rechte vorbehalten.siemens.com/lowvoltage New Legislative Framework (NLF) Sektor Infrastructure & Cities | Division Low and Medium.

European Commission Rita L’ABBATE Legal aspects linked to internal market DG Enterprise and Industry MARKET SURVEILLANCE COMMUNITY FRAMEWORK UNECE “MARS”

S tefano S oro European Commission Health and Consumer Protection DG OBLIGATION OF PRODUCERS AND DISTRIBUTORS TO NOTIFY DANGEROUS PRODUCTS.

The New Approach and GPSD. Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards [OJ C136 of June 1985] New Approach.

Directorate General for Enterprise and Industry European Commission The New Legislative Framework - Market Surveillance UNECE “MARS” Group meeting Bratislava,

REVISION of IVD DIRECTIVE Regulation instead of Directive.

Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Training on standardisation Support to the Modernisation.

Paola Lucantoni Economic and Financial Market Law.

Problems of the procedure 1 The VAT identification number of the person in the other MS is not always mentioned in the SAD This VAT identification number.

The Transposition of the Falsified Medicines Directive – the UK story

THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS Responsibility in the handling of medical devices.

Position of the Japanese Government and Possible impact of the REACH on Japanese trade relations with the EU.

Workshop on conformity assessment procedures and certification of medical devices INT MARKT Kyiv, November 2011 Conformity assessment of medical.

Research Use Only products ‘RUO’

Genetic Technologist Registration and the AHCS

Director, Regulatory Affairs

Clusters working group COM/CAMD New Regulations

Strategy for IVD product development, validation and commercialization

Regulatory Updates Health Sciences Authority Singapore

Update on EU regulatory developments

Flowchart on overview of requirements

CA 101 Certification and Registration

Customs The EU AuthOrised ECONOMIC OPERATOR (AEO) PROGRAMME

66 items – 70% of circulated products

REACH 2018 Find your co-registrants and prepare to register jointly.

Environmental Communication and Marketing

The Internal Market of EU

Business seminar on export to Europe

New European Medical Device Regulations – major changes that will affect all devices Rene van de Zande EMERGO | President & CEO

Proposal for a Regulation on medical devices and Proposal for a Regulation on in vitro diagnostic medical devices Key Provisions and GIRP Assessment.

Certification system for prepackages

GenDx AlleleSEQR transition update

EU Export Refunds System Ante Boras 15th May 2018

Medical Device Design and Development

BS EN 10204:2004 Metallic Products – Types of inspection documents

BS EN 10204:2004 Metallic Products – Types of inspection documents

MEDICAL DEVICES CONTROL SYSTEM IN INDONESIA

Opening an IND: Investigator Perspective

Trade mechanisms review 13 March 2019 AGRI. G

Dr Manisha Shridhar Regional Advisor WHO-SEARO

Neopay Practical Guides #2 PSD2 (Should I be worried?)

2.1. Monitoring of products placed on the market To verify the products comply with applicable directives EC declaration of conformity and technical.

INTERFACES BETWEEN NATIONAL LEGISLATION AND DIRECTIVE 97/23/EC

The WTO-TBT-Agreement

2019 TVET APPLICATION PROCESS (NEW applicants)

Prescription-only vs. over-the-counter medicines

No Deal EU Businesses Workshop: New Approach goods and the UK marking

Working Party on Regulatory Cooperation and Standardization Policies

SIMPLIFIED MEASURES FOR CUSTOMER’S IDENTIFICATION

Presentation transcript:

Distributor meeting Regulatory aspects

Topics Customs  Regulatory RUO  IVD: limitations RUO  IVD: possibilities Registration IVDs CE  IVD Marketing and regulation Status in your territory

1 Customs  Regulatory Different acceptance criteria Customs: monetary value and safety of handlers (animal, infectious or toxic materials contents ). Regulatory: safety of patient (product-application). Different documentation required Customs: declaration on composition and value. Regulatory: full registration file.

2 RUO  IVD: limitations RUO not intended for diagnostic use. GenDx can not and does not support the use of RUO products for IVD purposes. Countries with IVD-regulatory requirements: Distribution non-registered IVDs = illegal and subject to sanctions.

3 RUO  IVD: possibilities GenDx RUOs and IVDs are IDENTICAL: Same production procedure Same quality and acceptance criteria Same quality control procedures Same performance Only difference: box label. Declaration of equivalence can be made available.

4 Registration IVDs Purpose: permission from national competent authorities to distribute IVDs in its territory. Procedure: supply information on intended use, design of device and technical evidence of safety. Method: submit registration file based on international format (GHTF) setup + additional territorial requirements. YOU CAN ASSIST IN THIS!

5 CE  IVD CE= Conformité Européene Valid only in: EU-/EER-member states, Norway, Switzerland and Turkey Outside of CE-territories CE has not IVD validity New IVD-registration is necessary

6 Marketing and regulation Marketing unregisterd products as IVD is illegal Check your territory’s rules for marketing IVD devices / RUO products

7 Status in your territory