MFB Fertility, Inc. Medical Device Distributor Checklist

• Site conducted

  Select

• Conducted on

  Date

• Prepared by

• Location
  Address

General Information

• Distributor Name:

• Distributor Full Address:

• City, State/Province, Zip/Postal Code, Country

• Total Employees

• No. of Warehouse Employees

• No. of Office Employees

Facility Information

• Facility Built in Year (YYYY):

• Yes

  No

  N/A

• Yes

  No

  N/A

Building Construction Material:

• Is there a Quarantine area?

  Yes

  No

  N/A

• Total Facility Area (Sq. Ft.):

Warehouse

• (Sq. Ft.):

Office

• (Sq. Ft.):

• Are there security controls?

  Yes

  No

  N/A

• (select all that applies)

  Yes

  No

  N/A

• CCTV Camera

  Yes

  No

  N/A

• Badge Access Key Access

  Yes

  No

  N/A

Burglar Alarm Fire Detection/Suppression

• Pest Control Provider

• Pest Control Frequency

  Annual

  Monthly

  Quarterly

• Calibration Provider

  In House Calibration

  External

  Not Applicable

• Calibration Frequency

• Housekeeping Provider

• Housekeeping Frequency

  Weekly

  Bi-Weekly

  Daily

• Are you also an importer for MFB?

  Yes

  No

  N/A

• Is there an ERP System?

  Yes

  No

  N/A

• Yes, Specify Name: No, Describe how resource planning is managed:

• Is there a temperature monitoring/control system?

  Yes

  No

  N/A

• Yes, Specify Name:

• Do you use a 3PL?

  Yes

  No

  N/A

• Yes, Specify your 3PL:

• Do you distribute products that require special storage requirement?

  Yes

  No

  N/A

• Yes, Specify storage requirement:

• Do you perform any relabeling activities including instructions for use per country specific languages or market requirement?

  Yes

  No

  N/A

• Yes, Specify your relabeling activities:

• Do you have a Distribution Agreement with MFB?

  Yes

  No

  N/A

• Yes, if yes, does it comply with IVDR?

  Yes

  No

  N/A

Quality Management System (QMS) Requirements

• Is there a documented QMS?

  Yes

  No

  N/A

• Is there a change control process to identify, document and assess changes introduced and how changes may affect compliance and performance of medical devices? (Such changes may have a significant impact and may have the potential to affect the performance of medical device distributed, i.e. setting of a heating/cooling system, relocating storage area, etc.)

  Yes

  No

  N/A

• Is there a document control and record control procedure? (This shall include complaint, adverse events, recalls/field safety notices, distribution records management and demonstration of traceability)

  Yes

  No

  N/A

• Is there a training procedure that describes a documented training program to ensure personnel are competent in performing their respective duties?

  Yes

  No

  N/A

• Is there a purchasing control procedure to qualify suppliers including your transportation partners?

  Yes

  No

  N/A

• Is there a complaint handling procedure to ensure appropriate economic operators such as Competent Authorities, Authorized Representatives and Importers are notified promptly?

  Yes

  No

  N/A

• Is there an investigation procedure to log complaints and investigate complaints related to distribution?

  Yes

  No

  N/A

• Is there an adverse event reporting procedure to ensure appropriate supply chain partners such as Competent Authorities, Authorized Representatives and Importers are notified promptly?

  Yes

  No

  N/A

• Is there a recall and/or field safety corrective action procedure to ensure recall/field safety corrective actions are conducted in a timely manner AND prevent recalled products re-entering supply chain?

  Yes

  No

  N/A

• Is there a control of non-conforming product procedure to log such incidents and prevent defective product entering market? (This shall include non-salable products such as damaged, expired, recalled or falsified products)

  Yes

  No

  N/A

Distribution Requirements

• Is there a receiving procedure that describe methods of verification and inspection activities to confirm: a). presence of CE mark; b). a declaration of conformity of the device has been drawn up; c). an UDI has been assigned by the manufacturer where applicable; d). the importer is identified?

  Yes

  No

  N/A

• Is there an inventory control procedure that ensures stock rotations are conducted AND First In First Out (FIFO)?

  Yes

  No

  N/A

• Is there a storage procedure to ensure products storage conditions comply with conditions set by the manufacturer? (This shall include product that requires controlled temperature storage if applicable and temperature excursion action levels)

  Yes

  No

  N/A

• Is there a procedure that describes returned product handling to prevent non-salable product re-entering supply chain (This shall include customer returns of recalled products)?

  Yes

  No

  N/A

• Is there a medical device disposal procedure that prevents non-salable products such as expired product, damaged product, recalled product, falsified products from re-entering supply chain and the disposal of such products are conducted according to local environmental regulations?

  Yes

  No

  N/A

• Is there a procedure that describes handling of customer orders including pick, pack and ship?

  Yes

  No

  N/A

• Are there distribution records that maintain traceability of medical devices sold to customer?

  Yes

  No

  N/A

• Is there a process control to ensure the product transportation conditions comply with conditions set by the manufacturer?

  Yes

  No

  N/A

• Is there a Disaster Recovery Plan and/or Business Contingency Plan in place?

  Yes

  No

  N/A