certificazione.prodotto@imq.it | www.imq.it |

• Australian Therapeutic Goods Administration (TGA)• Therapeutic Goods Administration

(TGA), Australia• Agência Nacional de Vigilância

Sanitária (ANVISA), Brasile• Health Canada (HC), Canada• Food and Drug Administration,

Center for Devices and Radiological Health (CDRH), USA

• Ministry of Health, Labour and Welfare, Giappone

Cos’è l’MDSAPPromosso dalle Autorità Regolatorie di 5 Paesi (Austra-lia, Brasile, Canada, Giappone e Stati Uniti d’America) il “Medical Device Single Audit Program” (MDSAP) è uno schema in cui attraverso un'unica verifica ispettiva al Sistema di Gestione della Qualità/Requisiti GMP (Good Manufacturing Practice) di un Fabbricante di Dispositivi Medici viene verificata la conformità ai requisiti normativi/regolatori di tutti i Paesi aderenti.

COS’ÈMDSASP:

AUTORITÀ REGOLATORIE ADERENTI A MDSAP

MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP)

IMQ, IL TUO RIFERIMENTOPER CONDURRE AUDIT MDSAP

I VANTAGGIPER I

FABBRICANTI

I VANTAGGI PER I FABBRICANTI• Un unico programma di audit per coprire i requisiti e

soddisfare le esigenze di molteplici Autorità Regolatorie

• Riduzione della durata e dei costi totali delle verifiche ispettive

• Unico interlocutore per le verifiche ispettive

COME SI SVOLGONO

GLI AUDIT

COME SI SVOLGONO GLI AUDITL'audit si divide in due fasi:• l'audit di fase 1, generalmente condotto in loco,

consiste in una revisione dei documenti ed è finalizza-to a stabilire l'estensione ed il programma di audit;

• l'audit di fase 2, anch’esso condotto in loco, permette di verificare che il sistema di gestione sia pienamente attuato e conforme ai requisiti regolamentari applicabili.

SERVIZIOFFERTI

DA IMQ

IMQ, attraverso l’accordo bilaterale siglato con SAI Global (Organismo di Certificazione riconosciuto da Health Canada ad operare nell’ambito dello schema MDSAP), può già eseguire con il proprio personale le verifiche ispettive MDSAP per i clienti interessati.

Per ulteriori informazioni, contattateci:certificazione.prodotto@imq.it

• Australia: Therapeutic Goods (Medical Devices) Regulations 2002

• Brasile: Brazilian Health Surveillance Agency, Resolutions RDC_16_2013, RDC_23_2012 and RDC_67_2009

• Canada: Medical Devices Regulations (SOR/98-282)

• Giappone: Japanese Medical Device QMS Requirements and other related Regulatory Information

• USA: 21 CFR 820 (Quality System Regulation) e requisiti specifici delle autorità di regolamen-tazione dei dispositivi medici che partecipano al programma MDSAP, incluso il 21 CFR 803, 806, 807 e 821.

REQUISITI REGOLAMENTARI MDSAP

certificazione.prodotto@imq.it | www.imqgroup.it |

• Therapeutic Goods Administration (TGA), Australia

• Agência Nacional de Vigilância Sanitária (ANVISA), Brazil

• Health Canada (HC), Canada• Food and Drug Administration,

Center for Devices and Radiological Health (CDRH), USA

• Ministry of Health, Labour and Welfare, Japan

What is MDSAP?Promoted by the Regulatory Authorities of 5 different Countries (Australia, Brazil, Canada, Japan and United States of America), the “Medical Device Single Audit Program” (MDSAP) is a certification scheme to assess the conformity to the standards/regulatory require-ments of all the participating Countries, by means of a single audit to the Quality Management System/GMP (Good Manufacturing Practice) Requirements of a Manufacturer of Medical Devices

MDSASP:WHATIS IT?

PARTICIPATING REGULATORY AUTHORITIES

MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP)

IMQ, YOUR PARTNERFOR MDSAP AUDIT

BENEFIT FORMANUFACTURERS

BENEFIT FOR MANUFACTURERS • A single audit program to cover all the regulatory

requirements and satisfy the Regulations of the different Regulatory Authorities.

• Reduction of auditing time and costs • Only one interlocutor for audits

MDSAP AUDIT MODEL

MDSAP AUDIT MODELThe audit is performed in two different phases:• Phase 1 audit: usually performed at the Manufactu-

rer’s location, it consists of in a documents review with the aim of establishing processes/tasks covera-ge and audit program;

• Phase 2 audit: always performed at the Manufactu-rer’s location, it assesses that the Quality Manage-ment system is fully implemented and in compliance

SERVICE OFFERED

BY IMQ

Thanks to a bilateral agreement signed with SAI Global (a Certification Body recognized by Health Canada to operates in the MDSAP scheme), IMQ is ready to provide inspection services for the MDSAP Certifica-tion to the interested Customers. For more information, please contact us: certificazione.prodotto@imq.it

• Australia: Therapeutic Goods (Medical Devices) Regulations 2002

• Brazil: Brazilian Health Surveillance Agency, Resolutions RDC_16_2013, RDC_23_2012 and RDC_67_2009

• Canada: Medical Devices Regulations (SOR/98-282)

• Japan: Japanese Medical Device QMS Requirements and other related Regulatory Information

• USA: 21 CFR 820 (Quality System Regulation), and specific requirements of medical device regulatory authorities participating in the MDSAP program including the U.S. FDA's 21 CFR 803, 806, 807, and 821.

MAIN STANDARD REQUIREMENTSMET BY MDSAP

AN IMQ GROUP COMPANY