quality management systems update · revision of iso 13485 • health canada will adopt iso...
TRANSCRIPT
![Page 1: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/1.jpg)
Quality Management Systems UpdateMEDEC Regulatory Conference – 2015/05/11
![Page 2: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/2.jpg)
Outline
• Revision of ISO 13485• Implementation of MDSAP• Revision of GD210• Links, References, and Contact Information
2
![Page 3: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/3.jpg)
Revision of ISO 13485• ISO 13485:2003 is the standard against which a manufacturer’s quality
management system must be audited in order to obtain or amend a class II,III, or IV medical device licence (ref. MDR s. 32(2)(f), 32(3)(j), 32(3)(p))
• In 2012, ISO/TC 210 Working Group 1 initiated a project to revise ISO 13485:2003.
• The final version of the revised standard was agreed to in a vote in December 2015.
• ISO 13485:2016 was officially published on February 25th, 2016.
3
![Page 4: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/4.jpg)
Revision of ISO 13485• The revision of the standard clarifies a number of existing requirements• The new version of the standard introduces a number of improvements
and new requirements.• New or enhanced requirements include:
– new requirement to document regulatory role(s) of the organisation;– application of risk management to all processes within the QMS;– Introduction of basic concepts of change management;– validation of QMS software;– clarification of the contents of a “medical device file”– new requirements for the protection of confidential health information;– new and enhanced requirements for infrastructure, work environment, and
contamination control;– new requirement for communication with Regulatory Agencies;– new requirements for design transfer activities and design files;
4
![Page 5: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/5.jpg)
Revision of ISO 13485• New or enhanced requirements include (cont’d):
– refocused requirements for control of purchasing activities;– new requirement that suppliers must notify organisations of changes to supplied
products;– new requirement to analyse service records for possible complaints;– enhanced/clarified requirements for the validation of processes;– new requirements for sterile barrier systems;– new requirement for the application of UDI (where required);– enhanced requirement for feedback (sources and use);– new sub-clause on complaint handling– new sub-clause dealing with reporting to Regulatory Agencies;– enhanced requirements for handling non-conforming products;
5
![Page 6: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/6.jpg)
Revision of ISO 13485• Health Canada will adopt ISO 13485:2016.• This will trigger a regulatory amendment as well as updates of existing
guidance documents.• Manufactures will be afforded a transition period to implement this revision.
– The current recommendation from ISO/TC201 WG1 is to extend the transition to February 25th, 2016.
– Health Canada will likely limit the transition period to December 31st, 2018 to coincide with the transition to MDSAP.
• Manufacturers should begin preparing their transition soon to avoid possible lapses in certification.
• Registrars will experience an increase in demand due to this transition, advance planning and scheduling is strongly recommended.
6
![Page 7: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/7.jpg)
Implementation of MDSAP• The Medical Device Single Audit Program (MDSAP) is a collaboration
between the Australian TGA, the Brazilian ANVISA, Health Canada, Japan’s MHLW and PMDA, and the US FDA.
• The program allows MDSAP recognised Auditing Organisation (AO’s) to audit manufacturers against ISO 13485, medical device GMP requirements and the regulatory requirements of participating jurisdictions in a single audit.
• MDSAP audits can replace most routine inspections for participating Regulatory Authorities and MDSAP audit reports and/or certificates can be used by manufacturers to support marketing authorisations in participating jurisdictions.
• The program is currently in a pilot phase that ends on December 31st of this year.
7
![Page 8: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/8.jpg)
Implementation of MDSAP• Participating in MDSAP can facilitate/accelerate market access in
participating jurisdictions. • Participating in MDSAP can reduce the number of audits/inspections that
manufacturers undergo.• The MDSAP program offers full transparency of auditing requirements and
practices to manufacturers. • The MDSAP program allows the participating Regulatory Agencies to pool
resources and technology to more efficiently and consistently regulate industry.
8
![Page 9: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/9.jpg)
Implementation of MDSAP• Since the core audit requirements of MDSAP are based on ISO
13485:2003, the model is currently under revision to implement ISO 13485:2016.
• Publication of the revised audit model (and companion document) is expected in the coming months.
• The incorporation of ISO 13485:2016 has consolidated and/or eliminated some country-specific requirements.
• It is expected that two versions of the MDSAP audit model will co-exist during the ISO 13485 transition period.
• The MDSAP Consortium is also exploring ways to streamline the audit model and to simplify surveillance activities.
9
![Page 10: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/10.jpg)
Implementation of MDSAP• On December 4, 2015, Health Canada published a notice that CMDCAS
would be replaced by MDSAP as of January 1st, 2019.• After this date, all manufactures of class II, III and IV medical devices will
require a valid MDSAP certificate in order to obtain, maintain, or amend medical device licences.
• On April 22nd, 2016, Health Canada published a FAQ document to provide clarification to manufacturers and stakeholders on the upcoming transition from CMDCAS to MDSAP.
• Additional information and guidance will be communicated to manufacturers and stakeholders as it becomes available.
10
![Page 11: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/11.jpg)
Implementation of MDSAP• Manufacturers are encouraged to educate themselves on the program by
reviewing publicly available information and communicating with their Registrar / AO.
• Manufacturers should plan their transitions early to ensure that their medical device licences remain valid.
• AO’s are expected to experience increasing demand as the deadline approaches; advance planning and scheduling is therefore strongly recommended.
11
![Page 12: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/12.jpg)
Revision of GD210• The current version of GD210 dates back to 2007.• The content of the guidance document is based on ISO 13485:2003.
• While the content of this guidance document is outdated, the upcoming transition to MDSAP and the length of document revision procedures coupled with any subsequent transition period means that a major re-write of GD210 would not lead to any meaningful implementation period.
12
![Page 13: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/13.jpg)
Revision of GD210• Despite these limitations, GD210 does need to be updated to account for
the revision of ISO 13485. • Other minor changes to align practices with those of the MDSAP program
may also be considered. • Currently, there is no established timeline for this revision.
• Ultimately, GD210 will cease to be relevant as of January 1st, 2019.
13
![Page 14: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/14.jpg)
Links, References, and Contact Information• You can access all MDSAP documents at the following address:
http://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/
14
![Page 15: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/15.jpg)
Links, References, and Contact Information
15
![Page 16: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/16.jpg)
Links, References, and Contact Information• Health Canada’s Notice and FAQ documents can be found at the following
location:
http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/index-eng.php
• Questions on QMS topics can be sent to:
16
![Page 17: Quality Management Systems Update · Revision of ISO 13485 • Health Canada will adopt ISO 13485:2016. • This will trigger a regulatory amendment as well as updates of existing](https://reader035.vdocuments.mx/reader035/viewer/2022070720/5ee0737fad6a402d666ba1aa/html5/thumbnails/17.jpg)
Thank You!
17