How to Verify a Chinese Medical Device Testing Laboratory

This page is for regulatory affairs, quality and sourcing teams at device brands, importers and US 510(k) applicants who are about to rely on a test report from a laboratory in China. It is also for Chinese manufacturers who want their reports to hold up when a customer or regulator looks closely. The first part is a checklist for any laboratory. The second part shows how to check SUNGO Lab's own accreditations, including what falls outside them.

Key points

• FDA holds the device firm responsible for evaluating the labs it uses and for the accuracy of everything it submits, as its February 20, 2024 communication on unreliable third-party test data makes clear.
• An accreditation certificate means little on its own. What counts is the scope document: standard number, edition, clause and limitations, valid on the date the test was performed.
• The legal entity and address on the report must match the certificate. Separate companies and separate sites hold separate accreditations.
• Subcontracted tests should be disclosed to you in advance, approved by you, and identified in the report.
• Biocompatibility studies raise extra questions: GLP status under 21 CFR Part 58 and, where relevant, FDA ASCA accreditation.
• A CMA mark is valid within mainland China only, and only for items in the lab's CMA schedule.
• SUNGO's laboratories belong to two independent legal entities, in Shanghai and Hefei, accredited by CNAS and IAS, both signatories to the ILAC MRA. SUNGO is not an ASCA-accredited laboratory, has no GLP certification, and its CNAS/IAS scopes do not include biocompatibility (biological evaluation) tests such as cytotoxicity or sensitization.

Why this matters: what FDA has said about third-party test data

On February 20, 2024, FDA published Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions. FDA reminds sponsors and manufacturers to carefully evaluate the third parties they engage for performance testing and to verify all results before submitting. It reports a growing number of third-party test labs, including numerous facilities in China and India, generating data that are fabricated, duplicated from other submissions, or otherwise unreliable. FDA has been unable to reach substantial equivalence determinations for affected devices, and it says such data call into question the integrity of the entire file. Firms are asked to scrutinize data they did not generate, especially biocompatibility and other performance testing, and to spot results that are improbable or impossible on their face. FDA encourages the use of labs accredited under its voluntary ASCA program, but says this does not substitute for the firm's own assessment of all third-party data.

FDA's Notifications on Data Integrity – Medical Devices page lists General Correspondence Letters issued to named third-party testing facilities. For each, FDA states that the facility copied the results of another study or created falsified or otherwise invalid data, and that until the firm adequately addresses these issues, all study data from all studies conducted at that facility will be rejected. Two of these facilities had earlier received FDA warning letters in September 2024 (laboratory oversight failures and animal care violations); FDA's May 2025 announcement explains why their data are rejected. In a September 18, 2025 update on its ASCA program page, FDA also reported withdrawing ASCA accreditation from certain laboratories after audits; ASCA Summary Test Reports from those labs are no longer accepted.

The practical lesson: you need to be able to show that the lab was accredited for that exact test on that date, and that the data are genuine. The checklist below helps you build that evidence before you submit.

A nine-point checklist for any testing laboratory

1. Who accredited the lab, and is that body an ILAC MRA signatory?

Testing laboratories are accredited to ISO/IEC 17025:2017 by an accreditation body. Signatories to the ILAC Mutual Recognition Arrangement recognize reports from laboratories accredited by other signatories within the specified scope. China's national body is CNAS (cnas.org.cn). Some Chinese labs also hold accreditation from foreign bodies such as IAS, which states on its testing laboratory page that it is an APAC and ILAC MRA signatory. IAS also notes on its About page that the Global Accreditation Cooperation Incorporated (Global ACI) replaced ILAC and IAF on 1 January 2026, and that its MRA will cover the scopes previously recognized under the ILAC MRA, so documents may use either name. MRA status concerns recognition between accreditation bodies; whether a report is accepted is decided by FDA, the notified body or the relevant regulator.

2. Does the scope cover your exact test, edition and clause on the test date?

Ask for the scope document and match it line by line to the report: standard number, edition year, clause or test item, and any limitation. Limitations are where problems hide. Three examples from SUNGO's own scopes:

• The Hefei CNAS scope lists GB/T 18029.25-2022 clause 5 (battery chargers) with the limitation "not tested: electromagnetic compatibility".
• The Hefei IAS scope lists ISTA 3A "except for Random vibration under low pressure".
• The Shanghai IAS scope lists ASTM F1140/F1140M for Test Method A only.

Some scope documents, including IAS scopes, list standards without edition years. In that case, ask the lab which edition it will apply and make sure the report states it. For an FDA submission, check that edition against FDA's Recognized Consensus Standards database. As a general example, the IEC 60601-1 edition FDA currently recognizes is Edition 3.2 2020-08 (recognition number 19-49), with US national differences applied. The same question applies to us: SUNGO's Hefei IAS scope lists IEC 60601-1 without an edition year. Finally, compare the test dates with the certificate's validity period and the scope's effective dates.

3. Does the legal entity on the report match the certificate?

Accreditation certificates name a legal entity and the accredited site. Compare both with the report. A group brand, sales office or sister company does not carry another entity's accreditation. SUNGO is a case in point: the Shanghai and Hefei laboratories are two independent legal entities with separate certificates, so a Hefei result must be covered by a Hefei accreditation, not a Shanghai one.

4. Is the accreditation mark used only for accredited results?

Accreditation bodies set rules on how labs may use their marks. CNAS's CNAS-R01:2023 (Rules for the Use of Accreditation Symbols and Claims of Accreditation, in Chinese) requires a CNAS-marked report that includes non-accredited items to state clearly that those items are outside the accreditation scope (clause 5.3.4). IAS publishes its policy on the combined ILAC/IAF/IAS marks on its testing laboratory page. If a report carries an accreditation mark, check every result on it against the scope, and ask the lab to show you how any result outside the scope is identified.

5. Is subcontracting disclosed and agreed?

Under CNAS-R01:2023 clause 5.3.5, a CNAS-marked report in which some results come from an external provider must identify those results clearly, and must mark them as outside the accreditation scope if the provider is not CNAS-accredited for them. Ask before you order which tests the lab would subcontract, approve them before work starts, and check that the report marks those results. Then check the subcontractor's own accreditation and, for biocompatibility, its GLP status, just as you would if you had hired it directly. At SUNGO, biocompatibility tests such as cytotoxicity, sensitization, irritation and implantation are performed by an external subcontracted laboratory, with the client's prior consent, and identified as subcontracted in the report; they are not within SUNGO's CNAS/IAS scope.

6. Can you see the raw data, photos and calibration traceability?

FDA expects firms to catch improbable or impossible results, which is hard to do from a summary sheet. Before you order, ask whether the lab will provide on request raw data or instrument printouts, photos of the samples and setup, sample identification (model, serial or lot number), and the calibration status and traceability of key equipment. Check that the photos show your device and that sample receipt, test and report dates are consistent. Ask us the same questions.

7. For biocompatibility submitted to FDA: was the study run under GLP?

FDA's Good Laboratory Practice regulation, 21 CFR Part 58, applies to nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for FDA-regulated products, including medical devices for human use (21 CFR 58.1). FDA's biocompatibility resource page What Should I Put in a Test Report? states that test reports for GLP studies must address the reporting requirements of 21 CFR 58. Ask the lab what its GLP claim is based on, and agree with your regulatory team how your submission will handle any study not run under GLP. SUNGO has no GLP certification, and SUNGO's biocompatibility work is subcontracted as described above.

8. FDA ASCA status for basic safety, essential performance and biocompatibility tests

FDA's voluntary Accreditation Scheme for Conformity Assessment (ASCA) covers selected FDA-recognized standards in two areas: basic safety and essential performance of medical electrical equipment, medical electrical systems and laboratory medical equipment (for example the IEC 60601 series), and biocompatibility (for example ISO 10993 tests). When a manufacturer submits a declaration of conformity with an ASCA Summary Test Report, FDA says it does not intend to request additional information on testing methodology. Current labs are listed in FDA's ASCA-Accredited Testing Laboratories database; labs with the status "FDA Initiated Withdrawal" or "Voluntarily Withdrawn" are on FDA's separate withdrawn ASCA testing laboratories list. SUNGO is not an ASCA-accredited laboratory, and neither SUNGO entity appears in either list.

9. CMA is a Chinese qualification, valid only in mainland China

Many Chinese reports carry a CMA mark, China's statutory qualification for inspection and testing bodies. CMA is valid within mainland China only, and only for the items listed in the lab's CMA schedule. It is not evidence of ISO/IEC 17025 accreditation recognized under the ILAC MRA. For US or EU use, look for CNAS or other ILAC MRA signatory accreditation that covers the specific test, and keep in mind that the regulator or notified body decides whether to accept the report.

How to verify SUNGO's accreditations

1. Identify the issuing entity on your report or quotation: Shanghai SUNGO Medical Technology Co., Ltd. (laboratory at Room 218/219/223/225, Building B, No. 958 Kangqiao East Road, Pudong New Area, Shanghai; the IAS certificate lists Room 218 only) or HEFEI SUNGO MEDICAL TECHNOLOGY CO., LTD. (Unit 03, Building 7, Wanmao Industrial Park, Pengyi Road, Zipeng Town, Feixi County, Hefei, Anhui). They are two independent legal entities; Hefei is not a branch of the Shanghai company.
2. Open the IAS directory entry: TL-1019 for Shanghai or TL-1119 for Hefei. Confirm the organization name and status, then use "View Certificate" to open the certificate and scope. In November 2026 both entries showed the status "Accredited".
3. Search for L22083 (Shanghai) or L24279 (Hefei) in the accredited testing and calibration laboratory search on cnas.org.cn; the search interface is in Chinese. Open the scope and find the rows for your standard, edition and clause.
4. If your test falls within ASCA, note that SUNGO is not listed in FDA's ASCA database.
5. If any row does not match your report, contact us with the report number and we will go through it with you.

What each SUNGO laboratory is accredited for, in brief (full list on our services page):

• Shanghai (CNAS L22083, CMA 240015340087, IAS TL-1019): medical face masks, medical gloves, surgical gowns and drapes, wound dressings and gauze; sterile barrier packaging, for example ASTM F88/F88M-23 seal strength and ASTM F1929-23 dye penetration under CNAS, and ISO 11607-1 and ASTM F1886/F1886M under IAS only; accelerated aging to ASTM F1980-21; and sterilization-related tests, including tests of sterility performed in sterilization process validation to ISO 11737-2:2019, and ethylene oxide residuals to ISO 10993-7:2008+A1:2019 (the edition FDA currently recognizes, recognition number 2-275; ISO published ISO 10993-7:2026 in April 2026).
• Hefei (CNAS L24279, CMA 260015342945, IAS TL-1119): manual and powered wheelchairs and scooters, including ISO 7176 parts such as ISO 7176-14:2022 (power and control systems), EN 12183:2022 and EN 12184:2022 under CNAS, and ANSI/RESNA WC-1 and WC-2 under IAS only; walking aids to ISO 11199-1/-2/-3 and ISO 11334-1/-4, with the exclusions listed in each scope (for example, the IAS scope excludes clause 7.3 Biocompatibility and toxicity of ISO 11199-1 and -2; the CNAS scope marks ISO 11199-3 clause 4.9 "not tested: biocompatibility"); transport simulation to ASTM D4169-23e1, ISTA 2A and ISTA 3A, with the exceptions listed in each scope; and accelerated aging to ASTM F1980-21.
• Medical electrical safety and EMC: Hefei laboratory, within IAS accreditation TL-1119 only. The scope lists, for example, IEC 60601-1, IEC 60601-1-8, IEC 60601-1-11 and ISO 80601-2-69 for electrical safety, and IEC 60601-1-2, IEC 61000-4-2, -3, -4, -5, -6, -8, -11 and -39, and CISPR 11 for EMC. These tests are not covered by SUNGO's CNAS or CMA accreditations.
• Biocompatibility: performed by an external subcontracted laboratory, with the client's prior consent, and identified as subcontracted in the report; not within SUNGO's CNAS/IAS scope. SUNGO has no GLP certification. The only ISO 10993-series method in SUNGO's scopes is ISO 10993-7 (ethylene oxide sterilization residuals) at the Shanghai laboratory.

Accreditation at a glance

What to send us and how to start

These documents let us map each request to a scope row before any work starts:

• Target market and submission route (for example a US 510(k) or EU MDR technical documentation), and who will review the report.
• The standards you need, with edition years and clauses, or your test plan or predicate device test list.
• Device description: model numbers, configurations and accessories, rated electrical data for powered devices, and materials in patient contact.
• Draft instructions for use and labeling, and any risk management outputs that set test conditions.
• For packaging and shelf-life work: a description of the sterile barrier system, the sterilization method and the shelf life you intend to claim.
• Any existing reports you want checked against our scope documents.

On samples: the quantity is set by each standard and your test plan, and we confirm it in the quotation. Tell us whether samples are production-equivalent, sterile or non-sterile, and include any chargers, accessories or software needed to operate the device. Before work starts, we tell you which accreditation, if any, covers each test and which tests would be subcontracted, so you can approve them. Send your test list to begin.

FAQ

Is SUNGO an ASCA-accredited laboratory?

No. SUNGO is not an ASCA-accredited laboratory and does not appear in FDA's ASCA database. SUNGO's laboratories are accredited by CNAS and IAS, both signatories to the ILAC MRA; whether test data in a submission are acceptable is FDA's decision.

Does SUNGO perform biocompatibility testing in-house?

Biocompatibility tests such as cytotoxicity, sensitization, irritation and implantation are performed by an external subcontracted laboratory, with the client's prior consent, and identified as subcontracted in the report; they are not within SUNGO's CNAS/IAS scope, and SUNGO has no GLP certification. The one exception is ethylene oxide sterilization residuals to ISO 10993-7, performed at the Shanghai laboratory within its CNAS, CMA and IAS (Annex B) scopes.

Which SUNGO laboratory performs medical electrical safety and EMC testing, such as IEC 60601-1 and IEC 60601-1-2?

The Hefei laboratory, within IAS accreditation TL-1119 only; these tests are not covered by SUNGO's CNAS or CMA accreditations. Wheelchair-specific electrical clauses, such as ISO 7176-14:2022 clauses 9.1 to 9.8, are in the Hefei CNAS scope.

Are the Shanghai and Hefei laboratories the same company?

No. Shanghai SUNGO Medical Technology Co., Ltd. and HEFEI SUNGO MEDICAL TECHNOLOGY CO., LTD. are two independent legal entities with separate certificates. Check that the entity named on your report matches the certificate you verify.

Can a CMA-marked report be used for a US or EU submission?

CMA is valid within mainland China only, and only for items in the lab's CMA schedule. For overseas use, check the CNAS or IAS accreditation for the specific test; the regulator or notified body decides whether to accept the report.

Where can I check SUNGO's certificates myself?

Use the IAS directory entries TL-1019 and TL-1119 on iasonline.org and the CNAS laboratory search on cnas.org.cn for L22083 and L24279. CMA certificate copies are available on request.

Check before you rely on a report

The same nine checks apply to a new supplier's lab and to reports already in your file. To have your test list mapped to SUNGO's scope rows, or one of our reports checked against our certificates, contact SUNGO Lab with your standards and report numbers.