Want to build a local CGM business without the complexity of developing CGM technology from scratch? Let us help with an SKD partnership. This allows your product to qualify as locally manufactured, helping you access government tenders, claim tax incentives, and qualify for reduced import duties, all under your own brand.
CGM SKD (Semi-Knocked-Down) is a manufacturing model beneficial for healthcare businesses looking to launch a CGM brand fast while meeting local assembly or manufacturing requirements.
Instead of importing fully finished products, you receive partially assembled kits from us, including the sensor core, transmitter, and applicator. Your team completes final assembly, packaging, and labeling locally for sale. We also provide technical support and guidance for manufacturing setup and regulatory preparation such as CE registration.
Four types of healthcare businesses that benefit most from the semi-knocked-down CGM manufacturing model.
Deeply familiar with local regulations but blocked by strict local content rules for finished imports? Under SKD partnership model, we help you fulfill all local assembly requirements, giving you an immediate compliant path to qualify for and win public healthcare tenders.
Equipped with strong brand power but trapped by the massive R&D costs of developing sensor technology from scratch? Our SKD model offers a ready-to-assemble shortcut to launch your own CGM brand while retaining full ownership of the final product.
Possessing advanced assembly lines or clean rooms but wanting to utilize this existing infrastructure to its fullest potential? Add CGM to your current pipeline through our SKD model and maximize your manufacturing advantages while lowering local operational and logistics costs.
Armed with a mature sales network but tired of reselling third-party brands and fighting price wars that erode your margins? Switching to our SKD model empowers you to launch your own branding, cutting out upstream markups to regain absolute pricing control.
Everything you need to assemble, certify, and commercialize CGM products under your own brand —from components to documentation.
We supply you with proprietary high-precision sensor chips, wireless transmitter PCBA, housings, adhesive patches and battery units pre-assembled and ready for your final integration.
You receive supporting documentation that simplify local regulatory registration, such as electronic performance verification reports, biocompatibility assessment, ISO13485, clinical study data reports, and IEC standard test reports, etc.
A dedicated patient or doctor app is available via API or SDK connection that supports glucose monitoring and reporting. You can also integrate it into your digital healthcare platform.
You receive inspection standards, verification procedures, and automated testing equipment to support stable assembly quality. These help your team validate component performance, reduce assembly variation, and maintain reliable quality before final product release.
We possess large-scale manufacturing capacity, able to produce millions of CGM units annually. As your business grows, we scale with you. No unexpected shortages. No production delays on your end.
You receive comprehensive kit specifications, component lists, production line equipment recommendations, and standardized operating procedures (SOPs) to support efficient assembly setup and consistent calibration workflows.
SKD works best for organizations that already have, or are on a clear path to obtaining the following. If you're unsure, we're happy to assess your situation together.
A valid local medical device manufacturing or distribution license, or a clear plan to obtain one.
Existing relationships with clinics, pharmacy chains, or platforms that serve diabetes patients.
Familiarity with local medical device registration —you lead the process, we provide the documentation.
Access to standard medical device assembly facilities and a cleanroom for final integration and packaging.
From initial alignment to ongoing supply —a clear five-step path to launching your CGM business locally.
Submit company profile, target market plan, and available resources for mutual feasibility evaluation.
NDA signing followed by sample kit evaluation and local regulatory feasibility analysis.
Define kit configuration, pricing, MOQ, branding scope, assembly standards, and support boundaries.
Delivery of SKD kits with training materials, regulatory documentation, and assembly SOPs.
Partner-led regulatory approval and market launch, with continuous supply from us.
Assembly is extremely straightforward. Every component features snap-fit mechanisms, and you will hear an audible click when each part is correctly in place. Also, we provide detailed instructions, cleanroom guidelines, quality assurance procedures, and training to ensure smooth assembly and reliable device performance.
OEM means we manufacture fully finished, ready-to-use CGM devices for you to brand and sell directly. Regulatory certifications such as CE or FDA remain under our responsibility, and you operate under a distributor/importer model.
With CGM SKD, we send you separate components including sensor, transmitter, adhesive patch, and applicator. You assemble them locally, which reduces shipping volume and lowers import tariffs since SKD often qualifies for lower duties. However, you must obtain your own local manufacturing or assembly license, complete final quality checks, and take full regulatory responsibility for the finished CGM products in your market.
OEM is simpler but relatively more costly. SKD is more flexible, and can often reduce import duties, or meet "Made in Country" requirements but adds regulatory and quality control duties.
Yes. For SKD partners, we can provide technical documentation and support needed for local regulatory applications such as CE registration.
Yes, CGM SKD partnerships are structured with regional or country-level exclusivity to protect your market position.