Company profile
A dedicated medical device CMO in Nanjing.
Founded 14 October 2024. High-end minimally invasive interventional devices, microwave and radiofrequency at the core — process engineering, scaled production and contract manufacturing on one site.
Built to manufacture, not to trade.
Jinghang Guoye Medical focuses on high-end minimally invasive interventional devices, with microwave and radiofrequency platforms at the core. Process engineering, scaled production and contract manufacturing are combined on one site, meeting the compliance requirements for contract production of both active and sterile devices.
The company operates from the Intelligent Manufacturing Industrial Park in Jiangbei New Area, Nanjing. A stable core management and technical team — key technical, quality and production positions held by staff with many years in the device industry — keeps production and quality management standardised and auditable.
We manufacture under the belief “Creating more possibilities for life”: to be the most trusted CMO partner in minimally invasive energy intervention, and to relieve patient suffering through precision energy technology.
Company at a glance
- Founded
- 14 October 2024
- Location
- Jiangbei New Area, Nanjing
- Business model
- Contract manufacturing (CMO)
- Manufacturing licence
- Class III, Jiangsu MPA
- Licensed scope
- III 01-04 · II 02-15
- Building area
- 2,040.87 m²
- Cleanroom
- 507.8 m², ISO Class 7
- Quality system
- GB/T 42061-2022 (ISO 13485:2016)
Facility
Measured area by area.
Building, production, cleanroom, inspection and storage — the numbers a customer’s audit team asks for first.
| Area | Size | What happens there |
|---|---|---|
| Building area | 2,040.87 m² | Whole facility, Building F1 |
| Production area | 700.64 m² | Assembly, packaging, equipment build |
| Cleanroom | 507.8 m² | Sterile single-use device production |
| Inspection area | 133 m² | Incoming, in-process and final release testing |
| Storage area | 500 m² | Raw materials and finished goods, controlled |
Licence & scope
What we are licensed to produce.
Manufacturing licence
Holder of a Medical Device Manufacturing Licence issued by the Jiangsu Provincial Medical Products Administration, with the qualifications and capability for compliant medical device production.
Licensed scope of production
- Class III
- 01-04 Microwave surgical equipment
- Class II
- 02-15 Surgical instruments (other)
Registered products manufactured under contract
Six registrations on these lines. Each is produced for the marketing authorisation holder; the certificates remain with the registrant.
| Product | Registration No. | Device type | Valid until | Status |
|---|---|---|---|---|
| Single-use microwave ablation needle | 国械注准20253010071 | Sterile, Class III | 2030-01-09 | Contract production |
| Microwave ablation generator | 国械注准20253010197 | Active, Class III | 2030-01-19 | Contract production |
| Single-use lung nodule localization needle | 苏械注准20242021492 | Sterile, Class II | 2029-07-14 | Contract production |
| Single-use radiofrequency ablation electrode | 赣械注准20242010142 | Sterile | 2029-07-08 | Contract production |
| Venous stripping catheter | 赣械注准20242020151 | Sterile, Class II | 2029-07-16 | Registered |
| Single-use puncture needle | 浙械注准20252142036 | Sterile, Class II | 2030-12-30 | Contract production |
Organization
A lean structure with clear authority.
Seven functions, short reporting lines, one management representative between the general manager and the shop floor.
Leadership
- General Manager
- Management Representative
Operations
- Production
- Engineering
- Quality
Business support
- Human Resources
- Sales
- Procurement
Quality management
The system behind the certificate.
Quality management system
Built to GB/T 42061-2022, identical to ISO 13485:2016.
Production management
Medical device GMP, including the sterile and implantable annexes.
Risk management
GB/T 42062-2022 (ISO 14971:2019) applied from design transfer through process validation and serial production.
Quality objectives
Customer satisfaction ≥ 95%; finished-product delivery conformity 100%.
“Every step under control, every product backed by quality.”
What you can audit on site.
Certified key positions
Key-position staff hold certifications with documented induction, annual training and assessment. Duties and authorisations are defined in writing.
Planned lead times
Multiple product families run in parallel on one site; standard orders are delivered within 15 to 21 days.
Vendor-managed inventory
Long-term supplier agreements support on-demand material supply and lower inventory held at either side.
Inspection at every stage
A dedicated four-person inspection team covers incoming, in-process and final release — raw materials, semi-finished and finished goods.
Controlled environment
507.8 m² cleanroom at ISO Class 7 (Class 10,000) for sterile assembly and packaging.
Audit-ready records
Batch records are retained and open to customer review; technical files and test reports are released under NDA.
Roadmap
First five-year plan, 2025–2030.
New plant, doubled capacity
Additional production space and cleanroom capacity for larger contract programmes.
Export certifications
Certification for regulated export markets and development of overseas distribution partnerships.
Research institute
A dedicated research institute and a multi-modality energy platform.
Corporate culture
What we are here for.
The most trusted CMO partner
The most trusted CMO partner in minimally invasive energy intervention.
Relieve suffering through precision
Advancing patient care with precision energy technology.
Safety · Professionalism · Co-creation
Safety, professionalism, co-creation, mutual success.
Regulation first
Regulation first; quality as the foundation; innovation as the driver; service that adds value.
Inside the plant
Real photos from our site — no stock imagery. Partners are welcome to visit and audit in person.
Contract manufacturing — how it works
NDA & requirements
Mutual NDA, then your market, device, volumes and registration holder.
Technical transfer
Drawings, materials, packaging and labelling reviewed against GMP requirements.
Pilot & validation
Pilot run from 500 units, process validation, inspection records issued.
Serial production
Scheduled batches, retained records, agreed delivery windows.