Electrical Safety, EMC and Biocompatibility: IEC 60601 and ISO 10993 Evidence

1. Key takeaways

For active devices and devices that contact the human body, the test evidence in a UAE submission falls under subparagraphs (c) and (d) of Article 6(1): subparagraph (c) requires an assessment of the marketing authorization compliance in reference countries and of clinical evaluation and other outcomes, and subparagraph (d) requires certificates of analysis or batch quality certificates. Our judgment is that whether a test report is accepted depends on three things: whether the qualifications of the issuing laboratory can be traced by EDE, whether the standard version is current, and whether the models covered by the report are exactly the models to be registered. Ambiguity on any one of the three earns a deficiency notice.

• Test evidence for active and body-contacting devices sits under Article 6(1)(c) and (d).
• Subparagraph (d) requires certificates of analysis or batch quality certificates.
• Acceptance of a test report hinges on laboratory traceability, current standard versions, and exact model coverage.
• Ambiguity on any of the three points produces a deficiency notice.
• Electrical safety and EMC reports are submitted on separate lines and are not merged.
• The service page lists laboratory requirements as a separate item alongside samples and certificates of analysis.
• Reports should state the standard version number and publication date explicitly.
• Where the product is also supplied to the EU or US markets, report versions consistent with those market submissions are used first.
• Batch quality evidence and design verification evidence must never be submitted as substitutes for each other.
• Model families require confirmation that the reports cover the entire range.
• Superseded standard versions are not used, and report conclusions must not conflict with the risk file or the insert.

2. Legal basis

The regulatory basis combines subparagraphs (c) and (d) of Article 6(1) of Federal Decree-Law No. 38 of 2024 with the laboratory and sample requirements of the EDE service page. The table below reproduces the instruments cited in the source material and their key points.

3. Expert insights

Insight 1: The acceptability of a test report comes from institutional traceability, not from the report itself. Our judgment is that under the reliance review framework, EDE more readily accepts reports issued by laboratories recognized in the reference countries, because this removes the need for an independent check of the laboratory’s qualifications. If a Chinese manufacturer uses reports from domestic laboratories, the qualification documents and the accreditation scope of that laboratory should be provided alongside; otherwise the reviewer has no basis for judgment.

Insight 2: The certificate of analysis or batch quality certificate under subparagraph (d) and the device test reports are two separate lines. The former addresses batch quality; the latter evidences the compliance of the product design and performance. Our arrangement is to submit neither as a substitute for the other: do not submit batch inspection reports as design verification evidence, and do not respond to batch quality requirements with type test reports. The two sets of documents are submitted in separate chapters, and the index marks the corresponding statutory subparagraph for each.

Insight 3: The standard version question demands particular caution during the Executive Regulations gap. The Decree-Law contains 181 articles, the Executive Regulations have not all been issued, and EDE plans to update the list of reference institutions. Our practice is to use currently valid versions and state the version number and publication date explicitly in the report; where the product is also supplied to the EU or US markets, reports consistent with those market submissions are used first, reducing the interpretation cost caused by version differences.

4. Practical recommendations

• For active devices, provide electrical safety and electromagnetic compatibility reports on two separate lines and do not merge them into one submission.
• For body-contacting devices, organize the biocompatibility evidence by the nature and duration of contact, in line with the risk management documentation.
• Where domestic laboratory reports are used, provide the laboratory qualification documents and accreditation scope alongside.
• State the standard version number and publication date explicitly in every report, and avoid superseded versions.
• Submit batch quality certificates and type test reports in separate chapters, and mark the corresponding subparagraphs (c) and (d) of Article 6(1) in the index.
• Verify the models covered by each report word by word against the models to be registered, and confirm for model-family submissions that the reports cover the entire family.

5. Verification checklist

• □ Electrical safety and electromagnetic compatibility reports are complete, with currently valid standard versions
• □ The biocompatibility evidence covers the actual nature and duration of contact
• □ The laboratory qualification documents or accreditation scope are attached to the dossier and traceable by EDE
• □ The certificate of analysis or batch quality certificate has been submitted under Article 6(1)(d)
• □ The models in the reports match the models to be registered exactly, and family submissions have confirmed coverage
• □ The test conclusions do not conflict with the relevant statements in the risk management documentation or the package insert

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the United Arab Emirates. Our team prepares MOHAP-compliant dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com