Onboarding a New Supplier: A Due Diligence Checklist

Choosing a new distributor or supplier in the medical device and aesthetic products sector is a decision that outlives the first purchase order. A weak counterparty can mean customs delays, documentation gaps, or a product that never should have left the warehouse. A structured due diligence process, run before any contract is signed, is how experienced procurement teams keep that risk out of the relationship from the start.

Why Due Diligence Comes Before the Signature

Due diligence is not a formality that follows a handshake; it is the evidence base the handshake should be built on. For regulated products, a counterparty's legal standing, quality systems and financial footing directly affect whether goods can legally reach the market and whether they will arrive on time, intact and traceable. Skipping this step shifts risk onto the buyer's own compliance file, since importers and distributors generally share responsibility for the products they place on a market.

Confirming Legal and Regulatory Standing

The first checks are the simplest to verify and the easiest to overlook:

• Corporate registration. Confirm the legal entity name, registration number and registered address match what appears on quotes, invoices and certificates.
• Authorization to trade the product category. A wholesale or distribution license appropriate to medical devices or pharmaceuticals, where the jurisdiction requires one.
• Relationship to the manufacturer. Whether the counterparty is an authorized distributor, an importer of record, or an intermediary, and whether that relationship is documented in writing.
• Sanctions and watch-list screening. A basic check against publicly available restricted-party lists before any funds move.

Quality System and Certification Evidence

A supplier's paperwork should demonstrate, not just assert, that its quality system is current:

| Document | What it should show | |---|---| | ISO 13485 / GMP certificate | Scope, certificate number, issuing body and expiry date | | CE certificate or Declaration of Conformity | Product scope matches what is actually being quoted | | Free Sale Certificate | Current, issued for the specific product line | | Recent audit or inspection summary | Closed findings, not just a pass/fail statement |

Certificates should always be verified against the issuing notified body or certification body's own register rather than accepted at face value, since copies can be outdated or, in rare cases, falsified.

Financial Stability and Operational Capacity

A supplier can have excellent paperwork and still be a poor long-term partner if it cannot deliver reliably. Useful indicators include years in operation, basic credit or trade-reference checks, warehouse and cold-chain capacity relative to the order volumes under discussion, and whether the company has faced a product recall or major regulatory action, and if so, how it was managed and documented. None of these alone is disqualifying; together they describe operational maturity.

Supply Chain, Traceability and Data Controls

Finally, due diligence should look one layer deeper than the counterparty itself:

• Can the supplier identify its own upstream manufacturer or raw-material source on request?
• Does it maintain batch and lot traceability records that would support a recall if one were ever needed?
• Are storage and transport conditions (temperature, humidity) monitored and documented, not just assumed?
• Is there a named contact for pharmacovigilance or quality complaints, separate from the sales contact?

A supplier that cannot answer these questions clearly is signaling a traceability gap that will surface later, usually at the least convenient moment.

The Takeaway

Due diligence on a new distributor or supplier is cumulative evidence-gathering, not a single document request. Legal standing, verified certifications, financial and operational capacity, and traceability controls together build a picture of whether a counterparty can be trusted with regulated product. Building this checklist into the onboarding process, before the first order is placed, is far less costly than untangling a problem after goods are already in the supply chain.

This is general educational information, not legal or regulatory advice; consult the current official texts and your competent authority.