When third-party warehousing and transport companies apply for the first time, they often face the dilemma of having no real customers, yet their quality system cannot operate without customer and product information. This is where sample documents play an important role: they are a key tool supporting internal management, compliance verification and risk control.
The core value of sample documents lies in two areas:
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System and process testing – the “touchstone” for verifying compliance. Medical device warehousing and transport rely on specialised systems such as WMS (warehouse management systems) and TMS (transport management systems). Sample documents are the core tool for testing how well these systems’ functions match business processes, helping to verify system functions and identify process gaps.
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Compliance verification and application support – sample documents can be used not only to verify business compliance in advance but are also a key focus of a third-party warehousing and transport company’s first application, specifically in testing the completeness of the record chain and rehearsing inspection processes. By using sample documents to build a virtual end-to-end business flow – “supplier qualification review form → goods receipt inspection form → cold chain transport record → outbound verification form” – companies can promptly detect missing records (such as an unfilled equipment calibration number) or logical inconsistencies (such as a receipt date later than the production date), ensuring that the record chain in real business meets regulatory traceability requirements.
The following sample document templates have been anonymised and show only the format requirements; they contain no real company or product information. Fields marked “[ ]” should be filled in with real information for the actual scenario, or replaced with a “For testing only” label.
Example 1: Medical device delivery note (accompanying goods)
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Use: when a third-party warehousing and transport company ships goods to customers
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Compliance points:
Must include the names of the medical device registrant, filer and contract manufacturer;
Cold chain transport must record temperature data (e.g. refrigerated truck temperature);
The document must bear a “For testing only” stamp.
Example 2: Medical device qualification review form (first-time supplier)
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Use: when working with a supplier for the first time
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Compliance points:
Obtain copies of qualification documents bearing the company seal (e.g. business licence, operating licence);
The review result must be signed by the head of the quality management department.
Two core principles must be observed when using sample documents:
They cannot replace real business records: real documents must be completed strictly according to actual operations; sample documents are only a “rehearsal tool” and must not replace real business records.
Key qualification information must never be invented: key information such as registration certificate numbers and licence numbers must be marked as placeholders with “[ ]”; fabricating numbers is strictly prohibited.
The above explains in detail the requirements for sample documents in the registration application of medical device distributors’ third-party warehousing and transport services
This article is part of our NMPA series. Everbiz is committed to sharing medical device expertise with industry clients and hopes, with its extensive hands-on experience in quality systems and product registration, to provide practical help and jointly advance the medical device industry
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