You hold the registration.
We hold the manufacturing licence — and the responsibility.

Under China's medical device registrant system, you — the registrant — hold the registration certificate. The platform's operating entity holds the manufacturing licence and bears the corresponding manufacturing responsibility. We commit to never holding the registration certificate for a client's product.

Our manufacturing licences cover three categories: sterile implantable devices, active devices, and in-vitro diagnostics. Delivered work to date spans ultrasound diagnostic systems, microwave therapy devices, orthopaedic surgical kits, oral anaesthesia catheters, ophthalmic observation devices and IVD kits. Tell us the device classification and intended use and we will confirm whether it falls within our licensed scope.

It depends on device classification and registration pathway, so we do not publish a single figure. After a scoping discussion we provide an indicative schedule and quotation covering design transfer, process validation, registration testing support and production. We would rather give you a defensible number than a headline one.

There are three routes: manufacturing and registering domestically, converting an existing imported product to domestic manufacture, or a licensed technology-transfer registration. Which one fits depends on whether your product already holds an NMPA import certificate and on your commercial objective. See our Entering China page for a route-by-route comparison.

ISO 13485:2016 and ISO 9001:2015 quality management system certification (obtained December 2023), medical device manufacturing licences covering the three categories above, CMA-accredited testing support, and TÜV certification for ethylene-oxide sterilisation. Full details are on our Credentials page. GLP nonclinical safety evaluation is carried out at the Yangtze River Delta National Innovation Centre for Drug Safety Evaluation Technology, which sits within the same national innovation system as the platform — an in-system capability rather than an outsourced one.

Yes. On-site quality audits by prospective registrants can be arranged. Contact us with your preferred dates and audit scope and we will coordinate access to the relevant production and quality areas.

Three commitments: we hold only the manufacturing licence and never the registration certificate; without your consent we accept only one registrant per product category for a set period; and pre-existing IP is identified and ring-fenced before work begins, while any IP generated during design and process validation belongs to you. Note separately that projects involving human-derived samples are subject to China's human genetic resources regulations, which must be assessed before any cross-border engagement begins.

Yes. Through our partnership with Jointown Pharmaceutical Group (SSE 600998), devices manufactured here and holding a registration certificate can enter its national distribution network — over 100,000 pharmacies and more than 10,000 county-level and above public hospitals, including hospital SPD and online channels. The distributor still runs its own commercial assessment, but arriving through a long-standing manufacturing partner with the compliance file assembled is a different route from a cold approach. This stage is optional — contract manufacturing on its own is entirely normal.