General Information

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):

Building Construction Material:

  • Is there a Quarantine area?

  • Total Facility Area (Sq. Ft.):

Warehouse

  • (Sq. Ft.):

Office

  • (Sq. Ft.):

  • Are there security controls?

  • (select all that applies)

  • CCTV Camera

  • Badge Access Key Access

Burglar Alarm Fire Detection/Suppression

  • Pest Control Provider

  • Pest Control Frequency

  • Calibration Provider

  • Calibration Frequency

  • Housekeeping Provider

  • Housekeeping Frequency

  • Are you also an importer for CSI

  • Is there an ERP System?

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

  • Is there a temperature monitoring/control system?

  • Yes, Specify Name:

  • Do you use a 3PL?

  • Yes, Specify your 3PL:

  • Do you distribute products that require special storage requirement?

  • Yes, Specify storage requirement:

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

  • Yes, Specify your relabeling activities:

  • Do you have a Distribution Agreement with CSI?

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

Quality Management System (QMS) Requirements

  • Is there a documented QMS?

  • 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.)

  • 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)

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

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

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

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

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

  • 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?

  • 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)

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?

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

  • 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)

  • 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)?

  • 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?

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

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

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

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

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