The CGM SKD model: local production, global standards.
Verid Bio was the first CGM provider to enable SKD/CKD production models overseas. Keep your own brand, your own registration and your own market — with the sensor engineering already solved.
What is semi knock-down (SKD)?
SKD means the original manufacturer supplies semi-finished products to your facility for secondary processing — enabling completion of finished product production, compliance and sales in your own market.
Key advantage: it leverages the strengths of both parties for medical device compliance, tariff optimization and regulatory policy adaptation.
Put plainly: the engineering-intensive work stays where the engineering is, and the market-facing work happens where the market is.
What SKD changes for you
- Landed cost moves from finished-device duty to component duty
- Your product can qualify as locally manufactured
- Local-content and public tender programmes open up
- Your organisation becomes the registration holder
- Brand, packaging, manual and app language are yours
Every kit starts with a finished sensor.
Electrode fabrication, membrane coating, calibration and final QC all happen on our line. What ships to you is a sterilized, calibrated sensor — your team adds the housing, the packaging and the local registration.
This division of work is what keeps your cleanroom requirement to final assembly only, and keeps the process-critical steps under engineering control.
What is inside a CGM SKD kit?
01 · Sterilized sensor kit
The sensing element, produced, calibrated and released on our line.
02 · PCBA transmitter
Electronics that convert the sensor signal into a radio transmission.
03 · Battery
Power source sized for the full wear period.
04 · Applicator main body
The mechanism that inserts the sensor.
05 · Applicator bottom cover
The mating part that completes the applicator.
06 · Packaging & documentation
Unbranded packaging, manual artwork and registration files for your local finish.
Component connections are designed as guided snap-fit operations, with SOPs and training provided during enablement.
How the SKD partnership works
Requirement alignment
Share your company profile, target market and resources. We assess feasibility and the right kit configuration.
NDA & in-depth assessment
Evaluate a sample kit while both sides assess your local regulatory route.
Formal agreement
Kit configuration, pricing, MOQ, branding scope and assembly standards — defined in writing.
First shipment & enablement
Kits, training material, assembly SOPs and the documentation package for your registration.
Local certification & supply
You lead local approval using the technical file. We keep supplying components as you scale.
What your facility needs
- Environmental — cleanroom Class 10,000 (ISO 8) or higher, for sensor housing assembly
- Equipment & quality — ISO 13485 quality management system, or an equivalent system
- Staffing — basic cleanroom protocol knowledge to start; full assembly training is provided by us
OEM vs. distribution vs. SKD
The differences are mostly about where the device is finished — and therefore who holds which obligation.
See the full comparison →Your brand, through the whole product.
SKD carries your branding beyond the device. Packaging, manual and the companion app can all ship under your brand — real-time readings, trend curves and TIR reporting included. You own the customer relationship; we keep the platform certified and updated.
SKD against every other way into CGM.
The model you pick determines where the device is finished — and therefore who owns registration, duty treatment and the customer relationship. Here is the whole map, not just the SKD slice.
| Whole-device import | OEM / private label | CGM SKD | CKD | |
|---|---|---|---|---|
| What you receive | A finished, foreign-certified device | A finished device, unbranded | Tested, calibrated core components | Near-all parts, largely unassembled |
| Who finishes it | Nobody — it ships done | The manufacturer | You, with SOPs & training | You, with deep capability |
| Local registration | Foreign holder | Foreign holder | Yours | Yours |
| Duty & local content | Finished-device duty | Finished-device duty | Component duty, local-value add | Component duty, highest local content |
| Facility requirement | None | None | ISO 8 cleanroom for final assembly | Full manufacturing footprint |
| Time to market | Fastest | Fast | Months | Longest |
| Best for | Testing demand | Fast brand launch | Local production + local registration | National self-sufficiency goals |
SKD is the deliberate middle: enough is done at the factory to keep local assembly simple and repeatable, and enough is left with you to control branding, registration and tender eligibility.
The advantages, in plain economics.
SKD is not a discount — it is a structural change in how the product is classified, registered and sold. Five advantages compound into a durable margin and market position.
Lower landed cost
Components attract different — usually lower — duty than a finished medical device, and several markets grant preferential treatment to goods with meaningful local value-add. That is a structural cost difference, not a one-off negotiation.
Tender & local-content eligibility
National health programmes and public tenders often favour or explicitly require locally manufactured product. Local final assembly plus local registration is frequently the difference between being able to bid and being excluded entirely.
Brand & lifecycle control
Packaging, manual, language and the companion app all ship under your brand. Your patients see your name, and the customer relationship — with its data and recurring revenue — stays with you.
Faster route to a real product line
A from-scratch CGM is a multi-year, capital-intensive programme. SKD removes sensor development from your critical path and gets you to market in a fraction of the time, while you build manufacturing experience in parallel.
Territory protection
SKD structures usually define regional or country-level exclusivity — commonly one partner per country — so your local-content investment is not undercut by a second partner next door.
A support package, not just parts
Regulatory documentation, assembly SOPs, training, software access via API or SDK and ongoing supply — the pieces that turn components into a sellable, certifiable product line.
SKD changes who holds which certification.
With SKD the finished product does not exist until you assemble it — so the certification question is answered in two halves, and it matters early in your planning.
The manufacturer’s half is the technical and clinical documentation your local registration depends on: performance verification reports, quality management certification (for example ISO 13485), and design and manufacturing information. Your half is the local approval itself — the filing, the authority questions and the certificate are held in your name as the local manufacturer.
In the European Union, CGM devices generally fall under Class IIb under the Medical Device Regulation and involve a Notified Body; requirements differ by market, so confirm the exact route with your local authority before fixing a launch date.
Manufacturer vs. your organisation
- We supply — technical file, V&V reports, ISO 13485 records, design & manufacturing info
- You hold — local registration, your brand, the commercial relationship
- We keep — the process-critical steps under engineering control
- You add — final assembly, packaging, local-language IFU
Deeper production footprint?
Partners planning full manufacturing can step up through our Leadership Alliance programme for the deepest tier of technology transfer.
See the Leadership Alliance →Eight questions to ask any CGM SKD manufacturer.
The difference between a parts vendor and a real SKD partner shows up in the answers to these — in writing, backed by documents, not a sales deck.
01 · What is in the kit — and what is not?
Get the exact component list and the acceptance criteria. A clear boundary between factory scope and your scope prevents surprises at the dock.
02 · Which certifications and quality records do you hold?
ISO 13485 quality system, batch testing and functional screening records, and the release criteria for every sensor lot.
03 · What documents will you supply for my registration?
Performance verification, quality certificates, design and manufacturing information — the technical file your local authority will ask for.
04 · What training and SOPs are included?
Assembly SOPs, in-process checklists, on-site enablement and how refresher training is handled as procedures change.
05 · How is supply continuity protected?
Batch and stock policy, lead times and the mechanism that keeps components flowing as your volume grows.
06 · Do you limit partners per country?
Territory exclusivity — usually one partner per country — should be defined in writing before signature.
07 · Can we start with a pilot order?
A pilot validates the product and your assembly process before you commit to annual volume.
08 · What software comes with the kit?
Patient or clinician app access via API or SDK, so your hardware has a real data experience behind it from day one.
CGM SKD questions, answered.
Is CGM SKD the same as OEM?
No. OEM supplies a finished, certified device for you to brand and resell. With SKD the device is not finished when it reaches you — you complete final assembly locally, which is what enables local content, local registration and different duty treatment.
How difficult is local assembly?
Component connections are designed as guided snap-fit operations, with SOPs and training provided during enablement. Teams without prior CGM experience typically establish a repeatable routine during enablement and improve cycle time with volume.
Do I need a cleanroom?
Final sensor housing assembly requires a controlled environment — typically Class 10,000 (ISO 8) or higher. If you already serve clinics or pharmacy networks, this is usually the largest capability you need to add.
Can I start with a pilot order?
Yes. A pilot validates both the product and your assembly process before you commit to annual volume. Treat it as the entry point to a long-term agreement rather than a substitute for one.
Who holds the local registration?
Your organisation. That is the point of local production: we supply the technical and clinical documentation package, and your business holds the approval in your market.
Do you limit the number of SKD partners per country?
Most SKD structures define regional or country-level exclusivity, commonly one partner per country. Territory terms are agreed in writing before signature.
CGM SKD, covered end to end.
The guides below answer the follow-up questions partners ask after the first call — from cost and MOQ to registration and choosing a manufacturer.
What is CGM SKD?
The complete primer on semi-knocked-down manufacturing — kit contents, the process and what to check before signing.
CGM SKD cost & MOQ
Set-up, per-kit cost and local registration — and how SKD compares to finished import on total landed cost.
Inside a CGM SKD kit
Sensor, transmitter, battery and applicator parts, explained component by component.
CGM SKD registration
Who holds the approval, what technical file the manufacturer supplies, and how to avoid the common stalls.
Choosing an SKD manufacturer
The pre-contract audit checklist — engineering ownership, documentation, training and supply continuity.
CGM SKD vs. finished import
Duty, tender eligibility, registration ownership and margin — side by side.