Application Guide for Third-Party Warehousing and Transport Services of Medical Device Distributors

1

Management requirements for third-party warehousing and transport companies

Third-party warehousing and transport companies must strictly follow the Good Supply Practice for Medical Devices, establishing quality management rules, a management system, operating procedures and implementation records covering the entire logistics, storage and transport process to ensure the quality and safety of medical devices during storage and transport.

2

Warehouse facility requirements

• Ambient-temperature warehouse

Operating area of more than 5,000 m², with temperature controlled at 15 °C – 25 °C.

• Cold store for reagent products

Warehouse area of more than 1,000 m².

3

Illustrated key requirements for the registration application

4

Frequently asked questions and expert answers

Question 1: What are the overall requirements for a company expanding into medical device warehousing and transport? Answer: the company must prepare to meet the licence application conditions, which mainly include:

01

Quality management system

Draw up system documents, record forms and work instructions to standardise processes.

02

Facilities and equipment

Warehouses matching the business scope and scale (such as ambient and cold stores), equipped with temperature and humidity monitoring systems;

Storage equipment such as racks, pallets and handling tools, fire-fighting equipment, and insect and rodent control facilities;

Transport and temperature control equipment such as refrigerated vehicles, insulated boxes and temperature data loggers.

03

Personnel qualifications

The quality manager must hold at least a college diploma in a medical device-related field or an intermediate technical title or above, and have more than 3 years of experience in distribution quality management;

Warehousing and transport staff must receive professional training and be familiar with medical device logistics management rules.

04

IT system set-up

Deploy a computerised information management system that meets the Good Supply Practice for Medical Devices (such as a WMS warehouse management system and a TMS transport management system), providing records and traceability across receipt, acceptance inspection, storage, dispatch and transport of medical devices, with real-time temperature and humidity monitoring, out-of-range alarms and data retention.

Question 2: How can companies resolve specific difficulties encountered during registration?

Answer: common difficulties include building the quality system, compliance of computer management software and preparing registration documents. We recommend engaging a professional consultancy to support the application, such as Everbiz, which:

• Has extensive practical case experience and is familiar with the entire process of third-party medical device warehousing and transport;

• Provides end-to-end support from system building to application and licensing, effectively shortening the registration cycle.

About EVERBIZ professional services

As a consultancy specialising in medical devices, Everbiz is committed to supporting industry clients with practical experience in quality system building and product registration. For further discussion, please contact us

Note: this series continues to focus on NMPA registration developments. For more medical device industry expertise, follow our future updates or contact the Everbiz team.