IECEE CBTL Testing Laboratory for IVD Medical Devices

Recently, the International Electrotechnical Commission (IECEE) officially granted CBTL (Certification Body Testing Laboratory) accREDitation to China's JJR Laboratory, covering 46 standards across two major fields: Medical Electrical Equipment (MED) and In Vitro Diagnostic Devices (IVD). This authorization marks international recognition of JJR Laboratory’s testing capabilities, enabling it to provide globally recognized cb test reports for medical device companies, significantly reducing the time and cost for products to enter overseas markets.

CB Reports: The "Golden Key" to Global Markets

As a global mutual recognition mechanism established by the IEC, the CB Scheme’s test reports are directly accepted by 53 member countries and over 100 certification bodies. Through JJR’s CB testing services, medical device companies can quickly gain the following core advantages:

- "One Test, MULtiple Certifications" to Reduce Costs and Improve Efficiency

A single test can meet multiple countries' entry requirements, avoiding repeated testing and saving up to 60% in certification costs and 3–6 months in time, enabling faster market access.

- Accurately Avoid Technical Barriers

Leveraging IECEE international standards (such as iec 60601-1, IEC 61010 series) and localized regulatory interpretations, JJR helps companies proactively avoid compliance risks in target markets.

- Enhance Global Market Trust

The CB mark, globally recognized as a symbol of quality, enhances product credibility among purchasers, regulatory bodies, and end-users.

MED & IVD Specific Authorization: Accelerating Global Market Access

In response to the stringent safety and reliability requirements in the medical field, this accreditation further strengthens JJR’s service capabilities in the following scenarios:

- Medical Electrical Equipment (MED)

Covers a full range of safety and emc testing for surgical equipment, monitoring equipment, imaging equipment, infusion equipment, dental equipment, phototherapy equipment, and more, ensuring compliance with IEC 60601 and IEC/ISO 80601 series standards to meet international regulatory access requirements.

- In Vitro Diagnostic Devices (IVD)

Provides electromagnetic compatibility and electrical safety testing for biocheMICal analyzers, chemiluminescence immunoassay analyzers, fluorescence immunoassay analyzers, blood glucose meters, hematology analyzers, coagulation analyzers, urine analyzers, molecular diagnostic devices, and more, supporting compliance with regulations such as CE IVDR and FDA 510(k).

Through the “China JJR Laboratory Testing + International Recognition Services” model, medical device companies can simultaneously advance multi-country registrations such as China’s NMPA, the EU’s CE, and the U.S. FDA, gaining a competitive edge in the global market.

With this expansion, JJR Laboratory has become a CBTL authorized for four major categories: EMC, ITAV, MEAS, and MED. It can now provide precise, one-stop services for various types of products, helping clients accelerate their global market deployment.

JJR Laboratory is established and operated strictly in accordance with ISO/IEC 17025 standards, boasting a total laboratory area of over 30,000㎡, including more than 10,000㎡ of dedicated testing space. It is equipped with thirteen major testing areas, including Electromagnetic Compatibility, Electrical Safety, Wireless Communication, Biosafety, Microbiology, Cleaning and Disinfection Validation, Specific Product Performance, Mechanical and Physical Testing, Chemical Analysis, Environmental Reliability, Optical Testing, Acoustic Testing, and a Large Animal Testing Facility.