CGM SKD Registration: A Guide to Local Approval

In the CGM SKD model, the single most consequential change is this: your organisation becomes the registration holder. That is what turns a semi-knocked-down kit into a locally manufactured, locally registered product — and it is also the step where most SKD projects either succeed or stall. (New to the model? Read what CGM SKD is first.)

This guide explains what local registration means in an SKD partnership, what the manufacturer supplies, what you are responsible for, and how to avoid the common stalls.

Why registration is the whole point of SKD

With OEM or finished-device import, the foreign manufacturer holds the approval and you operate under their certificate. With SKD, the product is finished in your country, so the approval sits with you — and that changes everything downstream:

• You own the market access. The registration is your asset, not a licence you rent.
• You qualify as local production. Local assembly plus local registration is frequently the prerequisite for public tenders and local-content programmes.
• You control the brand and lifecycle. Packaging, manual, language and the customer relationship are yours.

The two halves of the registration work

Registration in SKD is a division of labour. Understanding which half is whose is the single most useful thing to clarify before signing.

The manufacturer's half: the technical file

Your registration depends on documents the manufacturer must supply. These are the core of what you are buying in an SKD partnership:

• Performance verification reports — accuracy, wear and stability data generated on their own line
• Quality management certification — for example ISO 13485, with a scope that covers the sensor and kit preparation
• Design and manufacturing information — how the device is made, controlled and released
• Clinical or analytical performance evidence — what many authorities require for a CGM

These are controlled documents, usually released against an NDA and agreement, and a credible partner commits to answering your authority's follow-up questions after submission.

Your half: the local approval

The filing itself is held in your name. That means you lead:

• The authority submission and its fees
• Local-language IFU, labelling and packaging artwork
• Any local conformity-assessment or clinical-evidence requirements your market adds
• Post-market obligations — vigilance, change notifications and periodic reviews

Regulatory routes by region

Requirements differ sharply by market, and the exact route should be confirmed with your local authority before you fix a launch date. As a general picture:

• European Union — CGM devices generally fall under Class IIb under the Medical Device Regulation and involve a Notified Body
• Other regulated markets — most follow a similar device-class plus technical-file model, with local language and local-representative requirements
• Emerging markets — routes vary widely; local production is often an explicit advantage in tender and programme supply

The common thread is that the manufacturer's technical file is the foundation, and your local authority's requirements are the finish.

Where SKD projects stall — and how to avoid it

Registration stalls are rarely about the science; they are usually about documentation and sequencing:

• Documents promised but not produced. Ask for samples of the actual documents, not templates, before signature.
• Scope gaps. Confirm the ISO 13485 certificate actually covers the sensor and kit preparation, not just a related activity.
• No post-submission commitment. A manufacturer that will not answer authority questions after filing is a parts vendor, not a partner.
• Sequencing surprises. Start the registration conversation during evaluation, not after the first shipment.

How to sequence your SKD registration

1. During evaluation — confirm your market's route, what your authority requires, and what the manufacturer must supply
2. At agreement — get the documentation package list in writing, with samples
3. At first shipment — receive the full technical file alongside the kits and training
4. At filing — you submit, with the manufacturer answering technical questions as they arise
5. After approval — maintain vigilance and change management with the manufacturer as a committed partner

Frequently asked questions

Who holds the registration in a CGM SKD arrangement? Your organisation. That is the defining feature of local production — the manufacturer supplies the technical file, and you hold the approval in your market.

Does the manufacturer handle the filing for me? The filing is yours. The manufacturer supplies the technical documentation and answers authority questions about the supplied components.

What is the hardest document to get? Usually the performance verification and clinical or analytical evidence — which is why you should confirm it exists in sample form before you sign.

Is CE marking my responsibility in SKD? In the EU the device generally falls under Class IIb MDR and involves a Notified Body; the exact route depends on your specific product and market, so confirm with your local authority.

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Mapping your registration route? Talk to our team → — we will walk through what your market requires and what we supply.