For overseas registrants

Entering the China market
three routes, and how to tell which is yours

If you hold — or want — an NMPA registration for a medical device, these are the routes available and what each one requires of you.

Which route applies to you?

Three regulatory routes exist for bringing an overseas device into China. Which one fits depends mainly on whether your product already holds an NMPA import registration certificate.

RouteApplies whenWhat it producesWhat we do
Domestic manufacturing registration
国械注准 / 省械注准		Your product has no NMPA import certificate, or you want domestic-manufacture status for tender and pricing reasonsA domestic registration certificate held by your Chinese registrant entityLocalized design and development, design-to-manufacturing transfer, process validation, registration testing support, licensed production
Import-to-domestic conversion
国械注进 → 国械注准		Your product already holds an NMPA import registration certificate and you want to move manufacturing into ChinaA domestic registration certificate alongside or replacing the import certificateDesign transfer from the existing manufacturing file, process validation and scale-up, registration testing, licensed production
Licensed technology-transfer registration
国械注许		You are transferring the product to a Chinese registrant rather than registering it yourselfA registration certificate held by the receiving Chinese registrantTechnical documentation transfer, process re-validation, quality system alignment, production

Three questions that decide the route

1
Does your product already hold an NMPA import registration certificate?
If yes, import-to-domestic conversion is usually the shorter route — the existing technical file and clinical evidence can often be leveraged. If no, you are looking at domestic manufacturing registration.
2
Do you want to keep ownership of the registration, or transfer it?
Keeping it means you establish or use a Chinese entity as registrant, and we manufacture under contract. Transferring it means a Chinese registrant takes ownership through licensed technology-transfer registration.
3
What is the device classification?
Class II is registered at provincial level; Class III at national level, with correspondingly longer review. Classification also determines testing scope and whether clinical evaluation data is required. Tell us the intended use and we will confirm the likely classification.

Who does what

You (the registrant)The platform
Hold the registration certificateHold the manufacturing licence and bear manufacturing responsibility
Own the product design and all pre-existing IPRing-fence your IP before work begins; any IP generated in design and process validation belongs to you
Establish or designate the Chinese registrant entityLocalized design and development, design-to-manufacturing transfer, process validation
Decide the commercial and market strategyRegistration testing coordination, retained sample management, submission support
Approve the technical fileISO 13485 quality system operation and licensed production

The registrant always holds the registration certificate. The platform holds the manufacturing licence and bears the corresponding manufacturing responsibility — we never hold the certificate for your product.

Where we are today

One cross-border localization project is currently in execution — dental imaging equipment for a registrant based in South Korea, moving through localized design and manufacturing toward registration testing. Four further projects are in the pipeline for registrants based in Canada, the United States and the United Kingdom, and have not yet commenced. Full detail by category and pathway is on the Delivered Work page.

BEFORE YOU START — TWO THINGS TO CHECK

Human-derived samples. If your project involves human tissue or cells — including organoid-based evaluation — China's human genetic resources regulations apply to foreign-party participation, and approval or filing requirements must be assessed before work begins. Raise this with us at scoping stage.

Nonclinical safety data. Where your submission requires GLP-accredited nonclinical data, we will tell you at scoping stage how that work is sourced rather than leaving it implied.

Talk to someone directly

Overseas registrant enquiries are handled by Ms. Vincy Mo. Send the device classification and intended use and we will come back with the applicable route and what it requires.

Email
contact@seno.bio
Phone
+86-571-28253702
Office
Room 503-1, Building E1, Zheda Forest, Xihu District, Hangzhou
Tell us about your product See credentials
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