Medical Devices
JOINN adheres to the mission of “serving medical device innovation and safeguarding human health” and provides professional, reliable, and efficient testing and evaluation services for global medical device registration.
JOINN has established a quality management system complies with international standards (CNAS/ILAC-MRA accreditation) and has obtained CMA certification for inspection and testing institutions. It also possesses GLP qualifications from China NMPA, the US FDA, Japan PMDA, South Korea MFDS, and the OECD, as well as the AAALAC (animal welfare) accreditation. The evaluation data meet the registration requirements for global medical products. With a solid foundation of 30 years in drug safety assessment, JOINN can offer one-stop service projects covering nonclinical drug, veterinary drug, pesticide, and medical device testing and evaluation. JOINN is always committed to the safety evaluation of medical products and is dedicated to providing professional services and solutions for global drug and device R&D to ensure the safety of medical products and protect human health.
Services
Biocompatibility Testing (FDA GLP, CMA, CNAS)
In Vivo Testing
a. Irritation Tests (skin irritation, intradermal reaction, eye irritation, penile irritation, vaginal irritation, rectal irritation, oral irritation) GB/T 16886.10-2017 idt ISO 10993-10 2021
b. Pyrogen Test GB/T 16886.11-2021 idt ISO 10993-11 2017
c. Implantation Tests (subcutaneous implantation, muscular implantation, bone implantation, brain implantation, ophthalmic implantation, dental implantation) GB/T 16886.3-2019 idt ISO 10993-3 2014
d. Toxicity Tests (acute, subacute, subchronic, long-term) GB/T 16886.11-2021 idt ISO 10993-11 2017
e. Sensitization Tests (bipolar, closed patch) GB/T 16886.10-2017 idt ISO 10993-10 2021
f. Thrombosis Test GB/T 16886.4-2022 idt ISO 10993-4 2017
In Vitro Testing
a. Cytotoxicity (MTT method, extraction method, agar diffusion method) GB/T16886.11-2021 idt ISO 10993-11 2017
b. Genotoxicity (bacterial reverse mutation, chromosomal aberration, TK gene mutation, in vivo micronucleus test) GB/T 16886.3-2019 idt ISO 10993-3 2014
c. Hemocompatibility (hemolysis test, complement activation, platelet count, in vitro thrombosis) GB/T 16886.4-2022 idt ISO 10993-4 2017
Safety and Efficacy Evaluation
Large Animal In Vivo Evaluation (FDA GLP, OECD GLP from European Countries)
a. Cardiothoracic Surgery/Cardiology
b. Orthopedics
c. Ophthalmology
d. Dentistry
e. Dermatology/Cosmetic Surgery
f. Neurosurgery/Brain Surgery
g. Drug-Device Combination Evaluation
h. Toxicological Testing of Aesthetic Injection Products
Animal Disease Models
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Category |
Stable Models |
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Cardiovascular |
Mitral/tricuspid/aortic/pulmonary valve stenosis or insufficiency |
Patent Foramen Ovale |
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Ventricular septal perforation, myocardial infarction, heart failure models |
Atrial/ventricular septal defects |
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Dilated/hypertrophic/restrictive cardiomyopathy |
Atherosclerosis |
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Ophthalmology |
Wet age-related macular degeneration model |
Retinitis pigmentosa models |
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Orthopedics |
Spinal cord injury animal model |
Bone defect model |
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Fracture model |
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Neurological Diseases |
Alzheimer’s disease |
Depression/anxiety |
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Parkinson’s disease |
Epilepsy |
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Cerebral ischemia and necrosis diseases |
Spinal cord injury |
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Multiple sclerosis |
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Urinary System Diseases |
Surgically induced renal injury |
Prostate hyperplasia |
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Metabolic Diseases |
Hyperlipidemia and atherosclerosis model |
Obesity model |
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Diabetes model |
Hyperuricemia/gout model |
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Diabetes and complications |
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Tumors |
Subcutaneous tumor xenograft model |
Hematologic tumor model |
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Glioma model with intracranial long-term catheter placement |
Orthotopic tumor model |
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Dermatology |
Trauma model |
Burn/scald model |
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Systemic lupus erythematosus |
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Infectious Diseases |
Various bacterial and viral infections |
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Competitive Advantages
Facilities and Equipment: 100,000 square meters of space with complete and advanced facilities and equipment
Toxicology Expertise: Over 200 toxicologists with rich experience in DABT background
Pathology Expertise: International pathology equipment and team to ensure rigorous and scientific results
Team Expertise: 50+ veterinarians providing diversified technical support for both large and small animals
Resource Advantage: Multiple self-owned breeding sites across the country to ensure a sufficient supply of experimental animals
System Advantage: Multiple GLP reviews and certifications from five countries, with a complete set of international qualifications
