SUNGO Medical Device Testing Scope: CNAS, CMA and IAS in Shanghai and Hefei

Before placing a test order, regulatory, quality and sourcing teams usually need three answers: which SUNGO laboratory runs the test, which accreditation mark the report can carry, and how to check the certificates independently. This page answers those questions by service line, based on the current CNAS, CMA and IAS certificates and scope documents of the two SUNGO companies in Shanghai and Hefei. Capabilities that are not in those scope documents are not listed.

Key points

• SUNGO runs two laboratories under two separate legal entities: Shanghai SUNGO Medical Technology Co., Ltd., with its laboratory at No. 958 Kangqiao East Road, Pudong, Shanghai; and Hefei SUNGO Medical Technology Co., Ltd., with its laboratory in Zipeng Town, Feixi County, Hefei, Anhui Province.
• Shanghai focuses on medical consumables and sterile products: surgical gowns, drapes and clean air suits; masks, gloves, dressings and gauze; sterile barrier packaging; cleaning and disinfection validation and sterilization-related tests; and ethylene oxide (EO) residuals. It holds CNAS L22083, CMA 240015340087 and IAS TL-1019.
• Hefei focuses on assistive products and transport: manual and powered wheelchairs, scooters, walking aids, crutches, walking sticks with three or more legs, simulated transport and accelerated aging. It holds CNAS L24279, CMA 260015342945 and IAS TL-1119.
• Medical electrical safety and electromagnetic compatibility (EMC) are performed at the Hefei laboratory, within the scope of its IAS accreditation (TL-1119).
• Biological tests (cytotoxicity, sensitization, irritation, implantation and similar) are subcontracted by SUNGO to laboratories holding the relevant qualifications. In line with accreditation rules, the customer's agreement is obtained before subcontracting, and the report identifies the subcontracted items and the subcontractor.
• The CMA mark applies only to items in the CMA schedule, and the CMA certificate states that it is valid within the People's Republic of China. International mutual recognition is signed by the accreditation bodies CNAS and IAS; the two SUNGO companies are accredited laboratories, not ILAC members.

The three certificates

CNAS laboratory accreditation is issued by the China National Accreditation Service for Conformity Assessment. The certificate states that accreditation is granted against ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories (CNAS-CL01), and that the accredited scope is set out in the annex bearing the same registration number. The annex lists each test item with the standard edition, clause and any limitation.

CMA qualification is China's qualification for inspection and testing bodies, produced under the supervision of the Certification and Accreditation Administration of the People's Republic of China. The certificate states that testing capability is set out in the attached schedule, that the certificate is valid within the People's Republic of China, and that legal responsibility for reports rests with the certificate holder.

IAS accreditation is issued by the International Accreditation Service (IAS), United States. The certificates state that each laboratory meets AC89, the IAS Accreditation Criteria for Testing Laboratories, and complies with ISO/IEC 17025:2017, and that the accredited services are those in the attached scope of accreditation. IAS scopes list standards by number without edition years; partial accreditation is stated as an exclusion or limitation.

Service line, site and accreditation overview

All three certificates cover only what the annex, schedule or scope lists, and the same standard may be covered differently on each. The table is compiled from the six scope documents of the two sites. The standards and clauses column reproduces standard numbers as written in the certificates: entries with an edition year follow the CNAS or CMA documents, entries without a year follow the IAS scope. It gives examples only, and edition years are those in the scope documents, not necessarily the current edition. Whether a specific standard, clause or edition is covered is checked against the scope documents at the quotation stage.

Biological testing is subcontracted

Biological tests such as cytotoxicity, sensitization, irritation and implantation are not in the table. SUNGO subcontracts them to laboratories holding the relevant qualifications. In line with accreditation rules, the customer's agreement is obtained before subcontracting, and the report identifies the subcontracted items and the subcontractor. The EO residual testing in the table is a residual determination within the Shanghai laboratory's scope, not a biological test. Biocompatibility clauses in wheelchair and walking aid standards are marked as excluded or not tested in the Hefei scopes; when needed, they are also subcontracted. Requests can be sent through our contact page.

Where the work is done and under which accreditation

Each company holds its own certificates, and as the CMA certificates state, legal responsibility for a report rests with the certificate holder. Which company issues a report, and which mark it can carry, depends on which company performs the test and which scope covers it. The two sites hardly overlap at the standard level; the only overlap is accelerated aging (YY/T 0681.1 and ASTM F1980).

The CMA mark: listed items only, valid in China only

• CMA testing capability is defined by the schedule; items outside the schedule cannot carry the CMA mark.
• Both CMA schedules consist mainly of Chinese national and industry standards, with a few international standards: the Shanghai schedule includes ISO 6710:2017, ISO 16603:2004 and ISO 10993-7:2008+A1:2019, and the Hefei schedule includes some parts of ISO 7176, such as ISO 7176-1:2014. ASTM, EN, AAMI and ISTA standards are not in either CMA schedule.
• Editions in the CMA schedule and the CNAS annex do not always match; for example, the Shanghai CMA schedule keeps older, withdrawn editions such as GB 10213-2006 and GB/T 15171-1994.

CNAS, IAS and international recognition: accreditation bodies sign, laboratories do not

• A mutual recognition arrangement is made between accreditation bodies: each signatory accepts accreditation certificates issued by the other signatories as equivalent to its own.
• The CNAS certificates state that CNAS is a signatory to the mutual recognition arrangements of the International Laboratory Accreditation Cooperation (ILAC) and the Asia Pacific Accreditation Cooperation (APAC). According to the IAS website, IAS is an ILAC MRA signatory (testing, calibration and other scopes) and an APAC MRA signatory. The CNAS and IAS certificates of both sites carry the ilac-MRA mark.
• On 1 January 2026, the Global Accreditation Cooperation Incorporated (Global ACI), formed by merging ILAC and the International Accreditation Forum (IAF), began operating, and its MRA took over from the ILAC MRA. According to CNAS, CNAS joined Global ACI in October 2025 among its first members and is a full member. According to IAS, IAS has been a signatory member since the launch, and the ILAC MRA mark remains valid during the transition.

How to verify SUNGO's certificates

• CNAS: the certificate states that its validity can be checked in the directory of accredited bodies on the CNAS website. Search by registration number L22083 or L24279, or by company name, and review the annex.
• IAS: the "Search Accredited Organizations" directory on the IAS website can be searched by certificate number TL-1019 or TL-1119 to review the scope of accreditation.
• CMA: the inspection and testing section of the National Certification and Accreditation Information Public Service Platform has a search for qualified inspection and testing bodies. Use certificate numbers 240015340087 and 260015342945.
• Check the validity dates, whether the target standard and edition are in the scope document, and any exclusions or limitations.

Preparing a submission

• State the purpose of the report (registration in China, export or incoming inspection) and the accreditation mark you need (CNAS, CMA or IAS). This decides which scope the work falls under.
• List the standard numbers and editions; if only some clauses are needed, give the clause numbers.
• Model list: the main model, the models it is meant to cover, and the differences between them.
• Configuration: accessories, optional parts, and power supply or battery specifications; for active devices, the software version and operating modes.
• Instructions for use and labels; for registration testing in China, also the product technical requirements.
• Sample condition: whether samples are sterilized, already aged or transport-conditioned, and in final packaged form.
• If biological testing is needed, say so when placing the order. Sample quantities depend on the standard and test plan and are confirmed at the quotation stage.

FAQ

Where does SUNGO perform medical electrical safety and EMC testing?

At the Hefei laboratory, within the scope of its IAS accreditation (TL-1119). The scope includes IEC 60601-1 and IEC 60601-1-2 with their EN, GB and YY counterparts; the standards listed in the IAS scope are definitive.

Does SUNGO perform cytotoxicity, sensitization and other biocompatibility tests itself?

No. SUNGO subcontracts these biological tests to laboratories holding the relevant qualifications. In line with accreditation rules, the customer's agreement is obtained before subcontracting, and the report identifies the subcontracted items and the subcontractor.

Can a CMA-marked report be used for export?

The CMA certificate states that it is valid within the People's Republic of China, and the CMA mark applies only to items in the schedule. For export use, check whether the test is within the CNAS or IAS scope; acceptance depends on the requirements of the target market.

Is SUNGO an ILAC member?

No. The ILAC arrangement, carried forward by the Global ACI arrangement from 2026, is signed by accreditation bodies such as CNAS and IAS. The two SUNGO companies are laboratories accredited by those bodies.

Requesting a quote

Please give the product, the target standards and editions, the purpose of the report and the accreditation mark you need. We will confirm against the scope documents which laboratory performs each item and under which certificate. Service pages are linked in the table above, for example wheelchairs and walking aids, electrical safety, EMC and sterile packaging. To request a quote or a scope check, please use our contact page.