KeBiao Medical Submits IPO Prospectus: A Leading Third-Party Testing Platform Accelerating Medical Device Market Entry
In China, policy has always been the direct driving force for the third-party testing industry. Judging from the development history of China’s inspection and testing industry, third-party testing has gradually developed on the basis of the government’s progressive deregulation.
The newly revised Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the “Regulations”) officially came into effect on June 1 this year. Article 14 of the new Regulations clearly states: “Product testing reports shall comply with the requirements of the drug regulatory department under the State Council, and may be either self-testing reports prepared by the medical device registration applicants or filers, or testing reports issued by qualified medical device testing institutions entrusted for such purposes.”
Third-party testing agencies may also conduct registration testing for medical devices, thereby significantly expanding the range of options available to enterprises for registration inspections. This not only helps improve the competitive landscape within the industry and reduce the time required for companies to submit samples for testing, but also creates new development opportunities for third-party testing agencies, fostering a favorable environment for their growth.
Amid the national trend of gradually opening up the market for third-party testing agencies, Jiangsu Kebiao Medical Testing Co., Ltd. (hereinafter referred to as “Kebiao Medical”) was established. Leveraging years of accumulated professional expertise and talent resources, Kebiao Medical rapidly assembled its team and was officially founded in 2015 at the West Taihu International Medical Industrial Park in Changzhou, Jiangsu Province.
Source: Kebiao Medical
The company is the first third-party testing institution for medical devices in Changzhou and has received strong support from the government. As a key enterprise in the industrial park, Kebiao Medicine is facilitating the park’s development by establishing a third-party service platform.
Kebiao Medicine currently operates three testing facilities, covering a total area of 6,000 square meters, with nearly 60 employees. Its Safety Evaluation Center has constructed laboratories in accordance with the international standard ISO/IEC 17025 and the US FDA 21 CFR Part 58 regulations, featuring barrier-system animal laboratories, biological laboratories, and physicochemical testing rooms.
The center is equipped with over 100 sets of specialized testing devices.Including fully automated biochemical analyzers, semi-automatic coagulation analyzers, static exposure chambers, tissue embedding machines, rotary microtomes, total organic carbon (TOC) analyzers, airborne microbial samplers, laser particle counters, liquid chromatography-mass spectrometry (LC-MS) systems, gas chromatography-mass spectrometry (GC-MS) systems, and inductively coupled plasma mass spectrometry (ICP-MS) instruments, totaling more than 300 units.
Kebiao Medicine has obtained the national-level CMA and CNAS accreditation certificates for inspection and testing, as well as the Laboratory Animal Use License., is a professional third-party testing institution that complies with the requirements of the U.S. FDA 21 CFR Part 58 (GLP) system. The company primarily serves manufacturers in sectors such as medical devices, cosmetics, and pharmaceutical packaging materials, providing them with professional testing services, R&D outsourcing services, and preclinical research services.
Source: Biaoke Medical
According to Mr. Lin Shangyou, General Manager of Kebiao Medical, the company currently focuses on medical device testing as its core business, while also prioritizing specialized testing for cosmetics and pharmaceutical packaging materials.
Medical device testing is the core business of Kebiao Medicine, with a primary research focus on safety assessments for medical devices. The company offers 32 specialized services, including biocompatibility testing, microbiological testing, preclinical large animal studies, material chemical characterization, sterilization validation, and shelf-life validation. It helps enterprises address testing-related challenges encountered during product R&D and design, domestic and international registration, manufacturing, and sales. Its test reports are widely recognized and accepted.
Notably, the company distinguishes itself through testing services for implantable and interventional medical devices. Leveraging its extensive resources and technical expertise in the animal research sector, it has established a core competency in biocompatibility evaluation and preclinical animal studies of medical devices.
Moreover, it has established close partnerships with leading domestic and international testing and certification bodies, research institutions, renowned universities, and large Grade-A tertiary hospitals, striving to become the most competitive third-party scientific research, testing, and inspection service platform in the green, beauty, and health industries.
“Adhere to the principle of prioritizing ethical boundaries; adhere to the principle of prioritizing customer service.”
Kebiao Medicine stated that adhering to fundamental principles and ethical baselines is crucial in the third-party testing industry. Losing these principles equates to losing public credibility and the very foundation of one’s standing in the industry. Meanwhile, as a service provider, Kebiao Medicine remains committed to prioritizing customer service while upholding these core principles, delivering high-quality testing services to its clients.
High-quality testing services are built on strict quality control.Kebiao Medicine currently maintains 677 quality documents and participated in proficiency testing eight times in 2020, covering testing fields such as medical devices, laboratory animals, and disinfection products. The tests included routine clinical biochemistry, Salmonella detection in feed, microbial limit testing for non-sterile products, Klebsiella pneumoniae detection in laboratory animal feces, and pathogenic bacteria detection in disposable sanitary products.
Furthermore, Kebiao Medical has participated in multiple inter-laboratory comparisons and achieved satisfactory results. Meanwhile, the company implemented its 2020 Laboratory Surveillance Plan, conducting regular monitoring and evaluation of personnel qualifications and training, testing processes, facilities and environmental conditions, instrumentation and measurement traceability, record management, sample management, result reporting, impartiality and confidentiality, procurement management, and contract review processes, thereby ensuring the laboratory’s continued competence in testing.
Source: Biaoke Medical
Strict quality control ensures business excellence; likewise, social responsibility is indispensable for enterprises.During the pandemic, Kebiao Medical assumed responsibility for third-party testing services, conducting extensive testing on domestic medical devices, masks, and other products. During this period, it accepted 4,836 commissioned tests from the public, issued 3,800 reports, and provided testing services to nearly 1,000 enterprises, thereby accelerating product time-to-market.
Regarding the future, Kebiao Medicine stated that it will apply for additional certifications, such as those in the United States and from the Asia-Pacific Economic Cooperation (APEC), to ensure its reports gain broader recognition.
On the other hand, Kebiao Medical will continue to strengthen its capabilities in three key areas: medical devices, cosmetics, and pharmaceutical packaging materials. First, it aims to establish itself as a specialized testing and inspection institution for medical devices, while also building an innovative preclinical large-animal research platform and a practical training base for medical device promotion. Second, it seeks to become a specialized testing and inspection institution for cosmetics. Third, it will further expand its layout in pharmaceutical packaging materials and drug testing.
KeBiao Medical is headquartered in Changzhou and serves the entire country. It has established a regional presence in core cities such as Suzhou, Shenzhen, and Changsha, and plans to expand its business to other provinces and municipalities. By continuously strengthening regional collaborations, KeBiao Medical aims to provide more convenient, efficient, and professional services to medical device enterprises across China.