How to Determine Product Classification for Overseas Registration of IVD Products

How to Determine Product Classification for Overseas Registration of IVD Products

Determining the correct product classification is a mandatory first step when planning overseas registration for an in vitro diagnostic (IVD) product. Classification determines the applicable regulatory path, technical documentation requirements, review time, and post-market obligations. You should first verify that the product falls within the definition of a medical device or IVD in the target market, using sources such as the US FDA regulation 21 CFR 809.3, EU IVDR 2017/746, the China NMPA Measures for the Administration of Registration of IVD Reagents, or definitions adopted by GHWP member economies. The product is then positioned by intended use, risk class, and whether it is intended for self-testing or companion diagnostics, among other special characteristics.

Applicable Scenarios and Core Questions

This guidance applies to IVD manufacturers planning to register products in GHWP member markets, the European Union, the United States, Southeast Asian countries, Brazil, and other overseas jurisdictions. The central question is how to determine the regulatory class in each target country or region so that the registration strategy, technical file, and post-market plan are correct from the outset.

The most common source of delay is incorrect classification. Manufacturers often transfer their domestic classification directly to another jurisdiction without verifying the local device definition and classification rule. For example, a product classified as Class II in China may fall into a different risk class under the EU IVDR. A systematic approach is therefore essential.

Classification Decision Logic

Because classification rules are country-specific, use the following logic for each target market.

• Step 1. Confirm the local IVD definition. Check whether the product fits the definition applied in the target country or region. In the European Union, IVDR 2017/746 defines an IVD medical device as a reagent, calibrator, control material, instrument, or software intended for examination of human specimens for medical purposes. If the product is outside this definition, it will not be subject to IVD regulation.
• Step 2. Evaluate the intended use and risk characteristics. Consider factors such as self-testing, companion diagnostics, detection of high-risk pathogens, blood grouping, and the severity of the disease or condition for which the product provides information. In the EU, IVDs are divided into Class A, B, C, or D, where Class A represents low-risk general laboratory devices and Class D includes highest-risk devices such as HIV blood screening products. In the United States, FDA classifies IVDs as Class I, II, or III. In China, NMPA divides IVDs into Class I, II, or III.
• Step 3. Apply the relevant classification rules or product lists. Use the target authoritys official classification system. The EU IVDR Annex VIII provides product-specific classification rules, while FDA relies on 21 CFR Parts 862 to 866 and the 510(k) exemption list, and NMPA publishes an IVD classification catalogue for China. Compare your product characteristic line by line against these rules.
• Step 4. Assess existing documentation for reuse. If you already hold NMPA registration, CE marking, or FDA 510(k), you can use existing technical files, performance reports, risk management files, and clinical evidence as a starting point. However, the data must be evaluated against the new target market requirements. The EU IVDR, for example, asks for more intensive clinical evidence and may require a dedicated clinical study or a systematic literature review.
• Step 5. Confirm the registration route and responsible party. Many countries require a local agent or authorized representative for a foreign manufacturer, such as the EU authorized representative in Europe or a local responsible entity in several GHWP member states. Verify responsibilities for registration maintenance, adverse event reporting, and change notification at the beginning of the project.
• Step 6. Plan post-market obligations. Higher-risk products require more extensive post-market surveillance. In the EU, Class C and Class D products usually require periodic safety update reports, and some devices also need a post-market clinical follow-up plan.

Documentation and Evidence

For a reliable classification assessment, the following foundation documents should be available:

• Product description, including names, models, intended purpose, and compatible analyzer or instrument platform
• Technical principle description, such as immunochromatography, chemiluminescent immunoassay, or PCR-based methods
• Analytical performance data covering sensitivity, specificity, precision, linearity, and reportable range
• Clinical performance data, such as comparison studies against a reference method or peer-reviewed literature
• Risk management file prepared according to ISO 14971
• Quality management system certificate, such as ISO 13485 or MDSAP

Different target markets may require additional submission-specific documents. For the EU, manufacturers generally need a CE technical file, a performance evaluation report, a clinical evidence package, ISO 13485 certification, and a signed agreement with the EU authorized representative. For the US, a 510(k) submission may require a substantial equivalence comparison, performance data, intended use statement, labeling, and submission in eCopy or eSubmitter format. For China NMPA, manufacturers need the product standard, registration test reports, clinical trial data for Class II and Class III products in most cases, and quality system audit records. For GHWP member countries such as Brazil or South Korea, local registration usually requires the technical file, quality certificates, local agent authorization, and translated labeling and instructions for use.

Common Errors

• Directly applying your home-country classification to another regulatory system, which can distort the registration pathway
• Ignoring special restrictions on self-testing IVDs, which usually require additional usability studies and higher classification
• Treating companion diagnostic products as ordinary IVDs; companion diagnostics can be up-classified to Category C or D under the EU IVDR depending on the target disease and therapeutic product
• Failing to update classification when a rule changes, particularly during the transition of an EU product from the IVDD to the IVDR system
• Ignoring the classification of IVD software, which is assessed under separate rules and may carry Class C or Class D risk
• Preparing technical documentation in a format not accepted by the target authority, such as missing eSubmitter formatting for FDA or MDCG-style technical files in the EU
• Starting the project without a local agent or authorized representative in a market that requires one
• Assuming that labeling and instructions for use language do not need localization

Enterprise Preparation Checklist

• List the target countries and prioritize by registration urgency and commercial value
• Compile the full product description, intended use statement, technical principle, and previous registration history
• Conduct a systematic classification assessment for each target market and record the rationale in a classification memorandum
• Review available performance verification and clinical evidence to identify gaps and prepare a remediation plan
• Organize the risk management file in accordance with ISO 14971 and local requirements
• Confirm that your quality management system is certified to ISO 13485 or MDSAP
• Create labeling and instructions for use drafts that allow for multi-language translation and local symbols
• Identify and sign agreements with local agents or authorized representatives in each required market
• Build a realistic registration timeline that includes translation, notarization, and submission milestones
• Establish a post-market surveillance process for regulatory updates, changes, and vigilance reporting

AIMEILI Regulatory Perspective

In our practical experience supporting IVD registrations in multiple jurisdictions, classification errors are the leading cause of schedule delays. Many manufacturers begin CE or FDA work with a Chinese registration certificate in hand and assume that the NMPA class can be simply translated into another risk category. When the new authority later requests reclassification, most of the original technical file becomes inappropriate or incomplete, causing significant time and cost overruns.

We recommend that the project team spend one to two weeks at the beginning of the project researching and comparing the classification rules for each target country. Create a classification comparison table that lists the product characteristics, risk factors, intended use, and relevant rule or product list for each market. Decide which existing evidence can be reused, such as ISO 13485 certification, risk management documents, and analytical performance data, and which evidence must be adapted, including clinical evidence and labeling. Do not attempt to use one single technical file for every country. Instead, build a core file and create a branched version for each market.

It is equally important to choose and sign agreements with local agents before submission. In some emerging markets, changing an authorized representative after registration can be difficult and may cause the registration certificate to lapse. We advise manufacturers to keep control of the registration certificate and maintain a direct relationship with the regulatory authority where possible. For multi-country programs, an MDSAP-certified quality system can reduce duplicate audit burdens, but product classification must nevertheless be verified market by market.

Finally, do not overlook post-market change management. If the intended use, test technology, or performance claims change after registration, re-classification may be required. Establish an internal change control procedure to identify whether any product modification triggers a new submission.

Frequently Asked Questions

Q1. If my product is classified as Class I in China, will it necessarily be Class A under the EU IVDR? No. China Class I usually means low risk, but EU IVDR classification is based on the intended purpose and risk rules. Some products that are Class I in China can fall into Class B or even Class C under the EU IVDR. Therefore, you cannot assume equivalence between classification systems.

Q2. Does product classification require an opinion from a third-party organization? Classification is the responsibility of the manufacturer. However, if you are uncertain or the product is high risk, it is prudent to consult a specialized regulatory consultancy or, in the EU, a notified body. Some authorities require the local agent to confirm the classification before submission.

Q3. If the same product receives different classifications in different countries, what should I do? This is normal. You should determine the classification independently for each country and prepare your technical documentation according to the highest applicable requirement. For example, a product assigned to Class C in the EU and Class B in another country should be documented at Class C level so that much of the file can be reused, while still meeting local formatting and translation requirements.

Q4. How is software IVD classified? IVD software can have its own classification independent of the hardware platform. The classification is based on the function of the software, such as whether it provides diagnostic information or influences patient management. In the EU, software classification is addressed in IVDR Annex VIII and may result in Class B, C, or D depending on the clinical purpose. Software validation, cybersecurity, and risk documentation are essential.

Q5. Are self-testing IVDs treated as higher-risk products? Generally yes. Self-testing IVDs are considered higher risk than professional-use products because the user is not a trained laboratory professional. Under the EU IVDR, many self-test products are classified as Class B or higher, and FDA may require enhanced labeling and usability studies. Manufacturers must provide self-test instructions, user validation data, and human factors evidence demonstrating safe use by the intended lay user.