Quality Management Systems UpdateMEDEC Regulatory Conference – 2015/05/11

Outline

• Revision of ISO 13485• Implementation of MDSAP• Revision of GD210• Links, References, and Contact Information

2

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

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

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

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

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

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

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

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

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

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

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

Links, References, and Contact Information• You can access all MDSAP documents at the following address:

http://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/

14

Links, References, and Contact Information

15

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:

QS_MDB_HC@hc-sc.gc.ca

16

Thank You!

17