Compliance for the Global In Vitro Diagnostic (IVD) Device

In Vitro Diagnosis (IVD) refers to products and services that obtain clinical diagnostic information by testing human samples (blood, body fluids, tissues, etc.) outside the human body, thereby determining diseases or bodily functions. IVD can provide comprehensive and multi-level testing information for clinical diagnosis, exert a significant impact on clinical treatment plans, and hold high application value and clinical significance.

Currently, IVD devices are widely used in medical laboratories, point-of-care settings, and self-testing scenarios. Manufacturers planning to enter the global market to sell IVD devices must meet the relevant standards of each country and obtain corresponding certification certificates. This guide aims to outline the market access requirements for IVD devices in domestic and international markets.

Market Access Requirements in China (NMPA)

In China, IVD devices are classified into three categories (Class I, Class II, and Class III) based on risk levels, with each category subject to distinct regulatory requirements.

①　Class I devices require filing with the municipal drug regulatory authority.

②　Class II devices require submission of a registration application to the provincial drug regulatory authority.

③　Class III devices require submission of a registration application to the National Medical Products Administration (NMPA).

The application dossier shall include technical documentation, clinical evaluation reports, quality management system documents, and other relevant materials.

Additionally, products must comply with applicable national standards (GB), industry standards (YY), and technical specifications, such as GB/T 42125.1, GB/T 42125.2, YY 0648, GB/T 18268.1, and GB/T 18268.26.

Market Access Requirements in the EU

For IVD devices targeting the EU market, full compliance with the In Vitro Diagnostic Devices Regulation (IVDR) (EU) 2017/746 is mandatory. According to the classification rules specified in Annex VIII of IVDR (EU) 2017/746, IVD products are categorized into four classes (Class A, B, C, D), each corresponding to different review, assessment, and compliance requirements. Notably, Class A products do not require the involvement of a notified body.

For safety and electromagnetic compatibility (EMC) testing, IVD devices must meet the EU harmonized standards under IVDR, including EN IEC 61010-1, EN IEC 61010-2-101, EN iec 61326-1, and EN IEC 61326-2-6.

Market Access Requirements in the U.S.

For IVD devices targeting the U.S. market, compliance with relevant FDA regulations (including 21 CFR Part 809 - In Vitro Diagnostic Products for Human Use) is required. Manufacturers shall determine eligibility for 510(k) exemption in accordance with FDA classification guidelines and obtain FDA registration approval.

For safety and emc testing, IVD devices must meet the recognized standards designated by the FDA, such as IEC 61010-1, IEC 61010-2-101, IEC 61326-1, IEC 61326-2-6, and fcc part 15B.

It is worth noting that if IVD devices are intended for use in occupational settings (e.g., hospital clinical laboratories), they must also obtain NRTL certification in compliance with the U.S. OSHA (Occupational Safety and Health Administration) regulations under 29 CFR 1910, with assessment standards including UL 61010-1 and UL 61010-2-101. NRTL certification status is also a key focus of U.S. insurance regulators and Authority Having Jurisdiction (AHJ).

International cb certification Requirements

When the intended sales regions are not yet determined, manufacturers are advised to obtain CB certification first to facilitate rapid conversion to national certifications in various countries and regions in the future.

Taking IECEE CB certification as an example, IVD devices must comply with the following standards:

The iecee cb scheme is a mutual recognition system for electrical product test certificates administered by IECEE. Its primary objective is to help manufacturers achieve the ideal goal of "one test, multiple applications" by promoting the alignment of national standards with international standards and facilitating cooperation among product certification bodies, thereby boosting international trade.

Over 70 National Certification Bodies (NCBs) from more than 50 member countries within the IECEE CB Scheme have entered into multilateral agreements, enabling applicants to obtain national certifications or market access in other member countries of the CB Scheme based on a cb test certificate and test report issued by any NCB.

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