IMQ is the only italian organisation recognized as an authorized MDSAP Auditing Organisation

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 requirements 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.  IMQ is the only Italian organisation recognised as an MDSAP Auditing Organisation.

MDSAP Audit Approach

The audit is performed in two different phases:

  • - Stage 1 audit: usually performed at the Manufacturer’s location, it consists in a documental review with the aim to establish processes/tasks coverage and audit program;
  • - Stage 2 audit: always performed at the Manufacturer’s location(s), it assesses that the Quality Management system is fully implemented and in compliance with the applicable mandatory requirements.

Benefits 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

Participating Regulatory Authorities 

  • - Therapeutic Goods Administration (TGA), Australia
  • - Agência Nacional de Vigilância Sanitária (ANVISA), Brazil
  • - Health Canada (HC), Canada
  • - U. S. Food and Drug Administration (FDA), USA
  • - Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA), Japan

MDSAP Regulatory Requirements

  • - Australia: Therapeutic Goods (Medical Devices) Regulations 2002
  • - Brazil: Brazilian Health Surveillance Agency, Resolutions RDC ANVISA n. 665/2022, RDC ANVISA n. 551/2021, RDC ANVISA n. 67/2009
  • - Canada: Medical Device Regulations – Part 1 -SOR/98-282
  • - Japan: MHLW Ministerial Ordinance 169, Article 4 to Article 68, Japan PMD Act (as applicable)
  • - 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.

 

 Management system certification is the endorsement enjoyed by organisations that have chosen to equip themselves with efficient management systems and suitable skills and structures, aimed at continuous improvement. And the higher the prestige of the awarding body, the higher the value of the guarantee. Equipped with state-of-the-art technology, our laboratories have full capability to put products through all the checks required by the major European directives and international standards. The certifications issued by IMQ are synonymous with trust. They guarantee safety, performance, efficiency and quality standards. More than 10,000 companies have turned to IMQ to certify their products and stand out on the market. Notified body for the main EU directives, IMQ offers tests and CE certifications to assess the conformity of the products to the requirements required to be marketed on the European market. Inspections and audits validate the conformity of electrical installations, equipment, supplies and services with the applicable technical and legislative specifications. IMQ is leader in Europe in the conformity assessment activity, technical partner chosen by Ministries and Authorities for market control purposes. IMQ is a brand recognized by the market as a synonym of safety and quality, and an internationally recognized partner, a valued member of the main international regulatory work groups. All IMQ personnel are required to strictly observe professional secrecy. IMQ has been working for 70 years trying to anticipate the future, to make the present safer.