CER & Registration Service-Business Area-Shanghai Lingshi Medical Technology Co., Ltd.

CER

Feasibility Assessment, Data Collection and Analysis, Clinical Evaluation Report and Related Attachments Compilation, Document Quality Control

Regulatory&Registration

Product R&D Planning, Regulatory Consultation, Product Type Testing Onsite Support, Registration Dossier Compilation, NMPA & Overseas Registration Submission Support

Device

Research and Development
Animal Experiment
Registration Detection
Clinical Trial
Innovation Declaration
Registration Declaration

Ability

Registration application, clinical evaluation and QMS guidance services for class III implantable and active medical devices.
Experience

Orthopaedic implants, polymer consumables, ECG monitoring equipment, electrosurgical instruments, laser treatment equipment.
Advantage

Clinical trials & registration services of innovative, high risk, implantable (Interventional) and surgical robot medical devices.

Registration Service - Service Case

Active

High frequency surgical equipment
ECG monitoring equipment
Laser therapeutic instrument
X-ray imaging system
Ophthalmic diagnostic instrument
Medical endoscope
Image processing software

Passive

Absorbable suture
Absorbable hemostatic material
Absorbable artificial bone
Oral implant
Suture anchor
Hernia repair patch
Metal locking plate

Clinical Evaluation - Service Case

Clinical Evaluation-Service case(Part)

Rich Experience in NMPA and CE clinical evaluation of three types of passive implanted medical devices (such as cardiovascular implants and cardiovascular interventional devices)
Rich Experience in NMPA clinical evaluation of three types of active implanted medical devices (such as cardiac rhythm management equipment)
Rich Experience in clinical evaluation of class II or III nmpa products in the《catalogue of medical devices exempted from clinical trials》

Products involved：Vascular stent, cardiac occluder, implantable cardiac pacemaker, puncture instrument, electrode lead, catheter sheath, guide wire, vena cava filter, blue light treatment equipment, balloon dilation catheter, etc.