Adhering to the mission of Empowering Medical Innovation, Safeguarding Human Health, JOINN Laboratories is dedicated to biocompatibility testing and efficacy evaluation of medical devices. Leveraging 30 years of technical strengths and quality control experience in pharmaceutical safety evaluation, we have developed a leading domestic and internationally aligned professional service platform for medical devices.
Our quality management system complies with the highest international standards. We have obtained dual certifications of CNAS/ILAC-MRA and CMA, GLP qualifications recognized by five major regulatory authorities including NMPA (China), FDA (USA), PMDA (Japan), MFDS (Korea) and OECD, as well as the authoritative international AAALAC accreditation for animal welfare, enabling global mutual recognition of test data.
We own 100,000 square meters of standardized laboratory facilities, a team of over 200 toxicology experts, more than 50 professional veterinarians and an international pathology platform. We provide a one-stop service system covering testing and evaluation of multiple categories of medical devices, eliminating barriers between R&D and registration. We deliver full-cycle, auditable, compliant and traceable technical support for global medical device innovation, fully guaranteeing the safety of medical products and contributing to human health.
Biocompatibility is a core indicator for the safety evaluation of medical devices. It directly determines the safety of products after contact with human tissues, blood and mucous membranes, and is a mandatory testing item for global regulatory registration.
In strict accordance with ISO 10993 and GB/T 16886 series of international and domestic standards, and backed by FDA GLP, CMA and CNAS qualifications, JOINN conducts comprehensive in vitro and in vivo biocompatibility evaluation. We accurately screen potential risks of device materials such as irritation, sensitization, toxicity and thrombosis, and provide compliant and authoritative test data for implantable, interventional and contact medical devices to facilitate smooth product registration.
1.1 In Vivo Biocompatibility Testing
In vivo tests simulate the actual contact scenarios between medical devices and human bodies. Standardized animal models are adopted to conduct short-term and long-term in vivo exposure evaluation, which objectively reflects the in vivo biocompatibility of devices. The test data is highly consistent with clinical practice and meets stringent requirements for global registration.
Irritation Test: Tests for skin, intradermal, ocular, vaginal, rectal and oral irritation, performed in accordance with GB/T 16886.10-2017 and ISO 10993-10:2021
Pyrogen Test: Detects pyrogenic risks of device materials, complying with GB/T 16886.11-2021 and ISO 10993-11:2017
Implantation Test: Evaluates implantation in subcutaneous, muscular, osseous, cerebral, ophthalmic and dental sites for various implantable devices, based on GB/T 16886.6-2022 and ISO 10993-6:2026
Systemic Toxicity Test: Conducts acute, subacute, subchronic and long-term systemic toxicity assessment to fully evaluate material toxicity risks, following GB/T 16886.11-2021 and ISO 10993-11:2017
Sensitization Test: Uses maximization test and closed patch test to screen sensitization risks and prevent adverse allergic reactions, per GB/T 16886.10-2017 and ISO 10993-10:2021
Thrombosis Test: Assesses thrombotic risks of blood-contacting devices, complying with GB/T 16886.4-2022 and ISO 10993-4:2017
Reproductive & Carcinogenicity Test: Evaluates developmental & reproductive toxicity and tumorigenicity of products, in line with GB/T 16886.3-2019 and ISO 10993-3:2014
1.2 In Vitro Biocompatibility Testing
In vitro testing features high efficiency, accuracy and reproducibility, and complies with the international 3R principle. It rapidly screens core indicators including cytotoxicity, genotoxicity and blood compatibility of device materials, providing efficient technical support for early R&D screening and subsequent registration.
Cytotoxicity Test: Adopts MTT assay, extraction method and agar diffusion method to detect impacts of materials on cell growth, per GB/T 16886.11-2021 and ISO 10993-11:2017
Genotoxicity Test: Includes bacterial reverse mutation test, chromosomal aberration test, TK gene mutation test and in vivo micronucleus test to screen genetic damage risks, complying with GB/T 16886.3-2019 and ISO 10993-3:2014
Blood Compatibility Test: Covers hemolysis, complement activation, platelet count and in vitro thrombosis detection for cardiovascular and blood-contacting devices, based on GB/T 16886.4-2022 and ISO 10993-4:2017
2. Safety and Efficacy Evaluation of Medical Devices
Safety and efficacy evaluation is a core procedure to verify the clinical value of medical devices. Professional in vivo assessment is carried out based on product indications and application scenarios.
With FDA GLP and European OECD GLP qualifications, JOINN has established a large animal in vivo evaluation platform to conduct customized efficacy and safety verification for various high-end medical devices covering multiple clinical departments. The scientific and authoritative test data fully supports preclinical evaluation and marketing registration of products.
2.1 Large Animal In Vivo Evaluation Services
Large animals share highly similar physiological structures with human beings, and their evaluation results are highly predictive, making them the preferred models for high-end, implantable and interventional medical devices. Equipped with a professional veterinary team and dedicated surgical facilities, our platform performs standardized in vivo tests to accurately assess the operational performance, therapeutic efficacy and safety risks of devices.
Brain-computer Interface Products: In vivo efficacy and safety verification for deep brain neurostimulators, spinal cord interface nerve stimulation systems for lower limb paralysis caused by trauma, etc.
Orthopedic & Dental Devices: Safety and efficacy testing for spinal fusion materials, bone defect fillers, artificial ligaments, artificial tendons, degradable bone screws, dental implants and dental restoratives
Ophthalmic Devices: Professional in vivo evaluation for corneal supplements, intraocular lenses, artificial corneas, artificial retinas, ophthalmic viscoelastic agents, trabecular meshwork stents, ophthalmic ablation devices, glaucoma drainage implants and phaco-vitrectomy systems
Aesthetic Devices: Safety and efficacy assessment for injectable sodium hyaluronate solution with active ingredients, injectable PDRN/sodium hyaluronate, recombinant/non-recombinant collagen and injectable filling microspheres, as well as systemic and local toxicity evaluation
Drug-device Combination Products: Integrated evaluation of synergistic efficacy and safety for innovative combinations such as drug-eluting central venous catheters, drug-coated balloons, drug-eluting stents and BMP-2 bone repair materials
Standardized animal disease models are essential for efficacy evaluation of medical devices. They can accurately simulate the pathological conditions of clinical diseases and improve the reliability and clinical relevance of test data.
After years of technological development, JOINN has built a library of stable animal models covering multiple systems and diseases. All models are fully validated with good reproducibility and typical pathological characteristics. We can customize exclusive models according to product indications to meet the personalized evaluation demands of innovative medical devices.
| Disease Category | Mature & Stable Animal Models |
|---|
| Cardiovascular & Cerebrovascular Diseases | Cerebral hemorrhage / cerebral infarction, heart failure / myocardial infarction, vascular stenosis |
| Ophthalmic Diseases | Cataract, glaucoma, wet age-related macular degeneration, retinitis pigmentosa, dry eye |
| Orthopedic Diseases | Spinal cord injury, fracture, bone defect, arthritis, osteoporosis |
| Neurological Diseases | Alzheimer’s disease, Parkinson’s disease, epilepsy, lower limb paralysis |
| Metabolic Diseases | Obesity, diabetes and diabetic complications |
| Dermatological Diseases | Trauma, burn/scald, systemic lupus erythematosus, skin ulcer, xeroderma, wrinkle model |
Facilities & Equipment
100,000 square meters of standardized laboratories equipped with world-class testing, surgical and pathological analysis equipment, supporting complex tests and special reproductive toxicity testing for medical devices
Toxicology Technology
A team of over 200 experienced toxicologists including DABT certified professionals, with in-depth experience in medical device safety evaluation and reproductive toxicity testing and strict technical control
Pathological Diagnosis
International pathological equipment and professional pathologists ensure accurate full-process analysis of test samples with rigorous, auditable and traceable data
Animal Technical Support
More than 50 professional veterinarians proficient in large/small animal surgery and husbandry, ensuring animal welfare and stable test data
Animal Supply
Multiple self-owned animal breeding bases nationwide with complete and sufficient animal species to avoid interruption of tests
Compliance System
Integrated certifications including GLP of five countries, CNAS, CMA and AAALAC. We have passed multiple international regulatory inspections, and test reports are accepted for global registration
