Credentials

Credentials & regulatory record
what actually matters when you assess a contract manufacturer

What decides whether your registration gets approved is not how many certificates a manufacturer holds — it is whether the licensed scope covers your device, whether the site passes registration system inspection, and whether responsibility is clearly allocated. This page is ordered accordingly.

HOW THESE CREDENTIALS ARE HELD

The credentials below are held by the platform's affiliated operating entity, which holds the medical device manufacturing licences and quality management system certifications under which all contract work is performed. The registrant always retains the registration certificate.

Regulatory record: inspection outcome

For a registrant, whether the contract manufacturer clears the registration quality management system inspection directly determines whether the registration certificate is granted. That record says more than any certificate, so it comes first.

Zero findings
March 2023 — first contract manufacturing project (Class II active device) cleared the drug administration’s registration system inspection
3 categories
Manufacturing licence covers sterile implantable, active and IVD devices — most contract manufacturers cover only one
TÜV CE
Supported a client product through TÜV CE certification for the EU market

That inspection record is the basis on which subsequent registrants and hospital partners have engaged with the platform.

Quality system & manufacturing

CredentialScopeObtained / issued by
ISO 13485:2016 (GB/T 42061-2022 idt)Medical device quality management systemDecember 2023 · Beijing Guoyixie Huaguang Certification Co., Ltd.
ISO 9001:2015 (GB/T 19001)General quality management systemDecember 2023 · Beijing Guoyixie Huaguang Certification Co., Ltd.
Medical device manufacturing licencesThree categories: sterile implantable devices, active devices, in-vitro diagnosticsProvincial drug administration
Class I medical device manufacturing filingClass I devices — includes a first-of-its-kind pure contract manufacturing filing in the regionMunicipal drug administration
Class II medical device distribution filingClass II device distributionMunicipal drug administration
CMA-accredited testing supportInspection and test reports issued under CMA accreditationAccredited testing body
TÜV certificationEthylene oxide sterilisation process; IAF / DAkkS accreditedTÜV

Seven things to confirm about any contract manufacturer

This checklist is not written for us. It is written for you — put it to any contract manufacturer, including this one. A manufacturer that cannot answer all seven is not ready for your next step.

1
Does the licensed manufacturing scope cover your device category and class?
The question is not whether they hold a manufacturing licence, but whether its scope covers your device type. If it does not, the project stalls midway. This platform is licensed across three categories — sterile implantable, active and in-vitro diagnostic devices — with a separate filing for Class I.
2
Have they been through a registration quality system inspection, and what was the outcome?
The inspection targets the contract manufacturer’s site and quality system. If it is not cleared, your certificate is not granted. Ask for the date, device class and outcome — not a general statement that the system is “robust”.
3
Who holds the registration certificate, and will they commit in writing not to hold yours?
Under the registrant system the certificate should stay with the registrant. Put “the contract manufacturer will not apply for or hold the registration for this product” into the contract, not just the conversation.
4
Do they already manufacture a competing device, and what separation is in place?
This is the single most common concern registrants raise in this market. Confirm whether they accept exclusivity within your device category, and how personnel assignment, document permissions and production areas are actually separated.
5
For cross-province arrangements, is the split of regulatory responsibility settled?
The NMPA opinion on coordinated supervision of cross-regional contract manufacturing sets out how the registrant’s and the manufacturer’s provincial authorities divide responsibility for system inspection, routine inspection, sampling and adverse-event monitoring. Confirm both sides read it the same way before you start.
6
Is their quality agreement and change control aligned to the 2026 GMP revision?
The revised Good Manufacturing Practice for Medical Devices takes effect on 1 November 2026, expanding from 84 to 132 articles and adding three chapters — quality assurance, verification and validation, and contract manufacturing and outsourced processing. Before it takes effect, registrants should re-check whether a contract manufacturer’s quality agreement, change control and outsourcing management meet the new requirements. Run the five-question 2026 GMP readiness check.
7
On termination, who owns the process files, validation data and retained samples?
Often overlooked, this clause determines what it costs you to change manufacturer later. Ownership and hand-over of process documentation, validation records, registration testing data and retained samples should be settled before work begins.

Based on the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739), the NMPA opinion on strengthening coordinated supervision of cross-regional contract manufacturing, and the revised Good Manufacturing Practice for Medical Devices (Announcement No. 107 of 2025, effective 1 November 2026). General assessment guidance; not regulatory advice.

Official designations

DesignationYear
High-Tech EnterpriseFirst designated 2020 · renewed, currently valid
"Kechuang China" Medical Device High-Tech Innovation Base (industry–academia–research category)2022
First cohort of municipally designated Innovative Medical Device Proof-of-Concept Platforms2022
State-owned holding contract R&D and manufacturing platform under the medical device registrant systemsince 2020
WHAT IS NOT LISTED HERE

Certificate numbers, validity dates and the licensed scope of each manufacturing licence are not listed here. On nonclinical safety evaluation: the accreditation does not sit under the Seno.Bio name. GLP studies are carried out at the Yangtze River Delta National Innovation Centre for Drug Safety Evaluation Technology, which belongs to the same national innovation system as the platform — this is an in-system capability, not an outsourced one. That centre issues the GLP report used in regulatory submission; the platform handles study design, organoid pre-screening and submission coordination.

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