Tender & public procurement

The document question, answered before you put us on your bid list.

Medical devices · mobility aids · home-care consumables

Tender work is the same product with a document list attached. What kills a bid is rarely the price — it is a certificate that cannot be produced on the day it is asked for.

Request the vendor pack → See what we carry

One reply within one business day, 08:30–18:00 GMT+8. Messages that arrive over our weekend are answered when we open on Monday.

01

The pack, in three parts

Most suppliers send one PDF and hope. We split the answer into what we hold, what we can apply for, and what we will not claim — so your document list gets a straight answer line by line.

What we provide

Already in the file, on request.

  • CE marking, per product — under EU MDR 2017/745. Where a notified body is involved we name the body and its certificate number; for devices self-declared as Class I we provide the technical file, the test reports and the factory’s Declaration of Conformity — and where the label carries your own name, that Declaration is yours to sign.
  • ISO 13485:2016 — held by the partner factories that make the order, not by us.
  • FDA establishment registration — facility registration records for the manufacturing site.
  • Batch records — functional test record or certificate of analysis per batch, where the product has one.
  • Shipping documents — one invoice, one customs entry, one document pack per mixed shipment.

What we apply for

Per bid, with a lead time attached.

  • Notarised or apostilled copies of certificates, where your authority requires them.
  • Translations of labels, IFUs and certificates into the language of the tender.
  • Country registration documents for markets outside the EU, on a per-market basis.
  • A manufacturer’s authorisation letter, issued by the factory for the bid reference.

What we don’t

Said here so it does not surface at evaluation.

  • We do not hold product clearance. FDA registration is a facility registration, not a 510(k) clearance or a PMA approval — any listing that implies otherwise is wrong.
  • We do not hold the ISO certificate in our own name; it belongs to the factories.
  • We do not bid on your behalf, and we are not your in-country agent. If you are putting your own brand on the goods instead, that is the private-label route.
  • We do not write a compliance claim we cannot document.
02

How a tender enquiry runs

Four steps, and the first one is the only one that needs you to do anything before a deadline.

01

Send the document list and the deadline

A scanned page of the tender’s document requirements is enough. You do not need to tidy it up first.

Reply within 1 business day
02

We answer line by line

Can provide, can apply for, or cannot — each line named, with a certificate number where one exists and a lead time where one does not. A “no” arrives in the same reply as the rest, not after you have built the bid.

03

Samples and the batch plan

Stock samples ship in 3–5 working days, courier paid by the buyer. Where the tender needs a pre-production sample, the batch plan is agreed before we cut it.

Samples in 3–5 working days
04

Documents start before production

The file is assembled while the goods are being made, not after. The pack ships with the order, so the goods and the paperwork land together.

03

What to send us

  • The tender reference and the closing date. The deadline decides what is realistic, before anything else is discussed.
  • The destination market. The same product needs a different document set per market — the market decides the list, not the SKU.
  • Quantities and divisions. Medical devices, mobility aids and home-care supplies ship on one invoice if the tender is mixed.
  • The document list from the tender, as written. A scan is fine; your own summary is fine too, as long as the wording is theirs.
  • How the bid is scored. Price-only and price-and-quality tenders need different answers from us.

If a document does not exist for the SKU you are bidding, we will say so in the first reply. Finding that out at evaluation costs you the bid and a season.

If the answer is no, we will usually tell you who can say yes.

Terry — the same person answers the form on the homepage and this mailbox.

04

The four claims we will not bend

These are the same four lines that appear on the homepage. They are worded this way because a tender evaluator will check them.

CE markingPer product, under EU MDR 2017/745. A notified body and its certificate number where one is involved; for self-declared Class I, the factory’s DoC and the technical file — and where the label carries your name, that DoC is yours to sign.
ISO 13485:2016 Held by our partner factories, not by the export office. We will name the site and the certificate.
FDA Facility registration, not product clearance. We do not hold product-specific FDA clearances or approvals (510(k) or PMA) and will not imply them.
TraceabilityLot number on the label, the test record for that batch, and the shipping documents that match them.
Can you supply an FDA 510(k) clearance for this product?

No. Our FDA status is establishment registration for the manufacturing facility. If your tender requires product clearance, we are the wrong supplier for that line and we will tell you on the first reply.

Can the ISO 13485 certificate be issued in your company name?

No. The certificate belongs to the factory that holds the quality system. What we can do is name the site, provide the certificate, and put your brand on the labels, IFUs and cartons — while the Declaration of Conformity stays yours to sign, which is what a private-label buyer needs to know before ordering.

We have a deadline next week. How fast can you answer?

One business day, 08:30–18:00 GMT+8. A message that lands after we close on Friday is answered when we open on Monday. If the deadline is inside that window, say so in the subject line and it moves to the top.

Send the document list. The first reply costs you one email.

Attach the page from the tender, or write the list out. You will get a line-by-line answer, including the lines we cannot fill.

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