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Medical Devices Notification of Changes or Regulatory Action

It is a requirement to inform SGS of any changes or regulatory actions that may affect the validity of your current certification or the scope of an audit. This should be done as soon as the information is known and this form must be used for such notifications. Requests for additional types of certification will usually require the completion of a full questionnaire

This form must be used in the following instances:

- To inform SGS of any significant changes or extensions that may affect current certification (e.g. changes to company name, locations, product range etc).

- To inform SGS of changes to data held by SGS (e.g. contact names, periods of unavailability for unannounced audits etc).

- To inform SGS of any regulatory action taken by you or any Regulatory Authority (e.g. EU Vigilance, product recall, FDA warning letter, new clinical investigation).

After review of any notified change or regulatory action SGS will decide to:

- Verify the change at the next scheduled audit at no extra cost;

- Update our database

- Change the wording on the certificate and make an administration charge;

- Inform you that extra time is required at the next audit;

- Undertake an additional audit or assessment for which you will be sent a costed proposal.

Please complete electronically. The client contact name shown below takes responsibility for the accuracy and completeness of this notification. When the information supplied in this form results in a change by SGS of certificate details without the need for a new proposal and application form, the contact name shown below agrees to the change and to the continuing validity of the certification contract with SGS.

|Client Name |      |Date |      |

|Client Contact Name |      |

|Contact Tel:       | |Fax: |      |E-mail: |      |

|SGS Contract Number (if Known)       |

|Current SGS Certificate Numbers      | | | |

We are notifying you of the changes detailed below

Change to (Changes can include additions and deletions)

|Please check all relevant categories of change and then give details. |X |

|The certified name and address, other site addresses, activities/scopes/ownership. | |

|Name and email of primary or second contact person. | |

|Number of employees covered by the scope of certification. | |

|Critical suppliers and sub contractors (give name, address, and product/service supplied for new suppliers). | |

|New or changed OEM’s where you own brand label the devices (give name, address, and devices for any new OEM). | |

|The structure of the quality Management System or links with related companies. | |

|Major quality system processes or activities. | |

|Major Production, testing or inspection processes. | |

|Sites where unannounced audits might take place (where final assembly/acceptance testing is undertaken). | |

|Periods of unavailability ( i.e. when an unannounced audit cannot take place) within the next 12 months. | |

|Medical device product range i.e. change to generic types manufactured or classifications. | |

|Other (please give details). | |

Details of Change (attach additional documents if required).

|      |

|Change date effective from. | |

|      | |

We are notifying you of Regulatory Actions and Approvals detailed below

|Please check relevant boxes and give further information below. |X |

|Regulatory approvals gained or stopped (e.g. USA, Brazil, Japan, Australia). | |

|Regulatory actions by any Regulatory Authority that have required you to take action, supply information or to restrict sale of | |

|your medical devices in any market. | |

|Adverse Event Reports (vigilance) which have required you to take remedial actions (please attach vigilance report, including | |

|your analysis of the root cause, revised/updated risk analysis and actions taken by you). | |

|New clinical investigation started (ethics committee approval required) or performance evaluation started. | |

Details of regulatory actions and approvals

|      |

Review of Notification by SGS Managing Affiliate

|Check appropriate response. |X |

|Change CertNet data. | |

|Prepare and Submit CWS for approval. | |

|Pass Notification of Change to GMDO for review. | |

Review of Notification by SGS GMDO

|Check appropriate response. |X |

|Certificate alteration only. (Administration charge) | |

|Review at next audit. (No charge) | |

|Proposal for costs associated with Change to Scope. | |

|Details of proposal required: | |

|Changes and Regulatory actions reviewed by GMDO. Date |

|GMDO name: |

Where action is required and following a review by SGS GMDO this form will be emailed to the client to inform them of the action planned.

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