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Medical Device Testing

Medical device testing for CDSCO, CE and export approvals.

Electrical safety and EMC to IEC 60601, ISO 10993 biocompatibility, sterility, endotoxin, sterilisation validation, packaging and device performance. We plan the tests around your CDSCO filing, use CDSCO-registered and accredited labs, and review reports before submission.

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Reviewed by Abhishek Singh, BIS Lead at Bizpro. Last updated 1 November 2026.

IEC 60601

Safety & EMC

ISO 10993

Biocompatibility

CDSCO

Registered Labs

Test Areas Listed

Medical Device Testing Explained

Testing that supports your CDSCO licence

Electrical Safety & EMC

IEC 60601-1 general safety, IEC 60601-1-2 EMC and the particular standard for your device, or IEC 61010 for lab and IVD equipment.

Biocompatibility

ISO 10993 tests chosen by body contact and duration, from cytotoxicity and sensitisation to chemical characterisation.

Sterility & Performance

Sterility, endotoxin, sterilisation validation, packaging and shelf life, plus device-specific performance tests.

At a Glance

Medical device testing: the key facts

What we do	Arrange medical device and IVD testing at CDSCO-registered and NABL-accredited labs, and plan it with your CDSCO filing
Regulation	Medical Devices Rules, 2017; laboratories registered for testing under Chapter X (Form MD-40)
Key standards	IEC 60601-1 / IS 13450, IEC 60601-1-2, IEC 61010-1, ISO 10993 series, ISO 11135, ISO 11137, ISO 11607, ASTM F1980
Reports used for	CDSCO import and manufacturing licences, CE, US FDA, tenders. See CDSCO registration
Consultant	Bizpro Compliance Services, New Delhi, arranges medical device testing at NABL-accredited and ILAC-recognised labs across India for manufacturers, importers, exporters and government suppliers: +91 920 500 6364, contact@bizprocompliance.com

Tests We Arrange

Medical device tests and standards we arrange

Safety, biocompatibility, sterility, packaging and performance tests for medical devices and IVDs. Search by device or test.

Showing all 19 tests and standards

No.	Test	Standard	Used For
1	Electrical Safety of Medical EquipmentBasic safety and essential performance of medical electrical equipment	IEC 60601-1 / IS 13450	CDSCOCEExport
2	Medical EMCElectromagnetic compatibility of medical devices	IEC 60601-1-2	CDSCOCE
3	Home Healthcare EquipmentSafety for devices used at home	IEC 60601-1-11	CDSCOCE
4	Particular Standards (60601-2-x)Device-specific safety, e.g. infusion pumps, monitors, ventilators	IEC 60601-2 series / ISO 80601-2 series	CDSCOCE
5	Laboratory & IVD Equipment SafetySafety of lab, diagnostic and IVD instruments	IEC 61010-1 / IEC 61010-2-101	CDSCOCE
6	CytotoxicityIn vitro cell toxicity of device materials	ISO 10993-5	CDSCOCEFDA
7	Sensitisation & IrritationSkin sensitisation and irritation potential	ISO 10993-10 / ISO 10993-23	CDSCOCEFDA
8	Systemic Toxicity & ImplantationAcute and sub-chronic toxicity, implantation effects	ISO 10993-11 / ISO 10993-6	CDSCOCEFDA
9	HaemocompatibilityBlood interaction of devices	ISO 10993-4	CDSCOCE
10	Chemical Characterisation & ExtractablesExtractables and leachables of device materials	ISO 10993-18	CDSCOCEFDA
11	Sterility TestingSterility of sterile devices	ISO 11737-2 / IP / USP 71	CDSCO
12	Bacterial Endotoxin (LAL)Pyrogen and endotoxin levels	USP 85 / IP methods	CDSCO
13	BioburdenMicrobial load before sterilisation	ISO 11737-1	CDSCOCE
14	Sterilisation Validation (EO / Gamma)Ethylene oxide residues and radiation dose validation	ISO 11135 / ISO 11137 / ISO 10993-7	CDSCOCE
15	Packaging & Shelf LifeSeal strength, integrity and accelerated ageing	ISO 11607 / ASTM F1980 / ASTM F88	CDSCOCEFDA
16	Syringes, Needles & CathetersPerformance tests for single-use devices	ISO 7886 / ISO 7864 / ISO 10555	CDSCOBIS
17	Gloves, Masks & GownsBarrier, filtration and physical performance	IS 15354 / IS 16289 / EN 14683 / ASTM F2100	CDSCOBIS
18	Thermometers & BP MonitorsAccuracy and performance of measuring devices	ISO 80601-2-56 / IEC 80601-2-30	CDSCO
19	Medical Device SoftwareSoftware life cycle and usability documentation review	IEC 62304 / IEC 62366-1	CDSCOCE

“” isn’t in this list

We arrange many more tests than are listed here. Tell us the product and the standard or specification, and we’ll confirm the lab and cost.

Tell us what the product is and we’ll confirm which approvals it needs, free.

Standards are listed by their current published reference; the exact edition is confirmed against your specification or the authority’s requirement before testing. Tests run at NABL-accredited and ILAC-recognised partner labs whose scope covers them.

Free medical device testing Assessment

Get your medical device testing quote and timeline

Tell us the product and the standard, specification or approval you’re testing for. A specialist confirms the test plan, lab, total cost and turnaround, in writing.

Reply within one business dayFrom a named consultant, not an automated sales sequence.
Fixed written quoteGovernment fees, lab charges and our fee listed separately before you commit.
Accredited labs across IndiaNABL / ILAC reports accepted by regulators and buyers.

What medical device testing costs

Testing chargesPer test, as quoted

LabNABL / ILAC accredited

TurnaroundConfirmed in quote

Bizpro professional feeFixed, in your quote

One written quote covering every test, so there are no surprises when the report is issued.

Request your free medical device testing quote

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How It Works

Your medical device testing in five steps

Medical testing is planned from your device’s classification, intended use and body contact, so you test once for CDSCO and export.

Standard & Test Plan

We confirm exactly which standard, clauses and tests apply, and why: certification, tender, export or customer approval.

Day 1

Lab & Fixed Quote

We choose a lab whose accreditation scope covers your tests and send one written quote with cost and turnaround.

Day 1–3

Samples & Documents

You send samples, datasheets and any drawings or specs. We check quantities so testing isn’t held up.

Day 3–7

Testing & Updates

The lab tests to the plan. Early failures are flagged straight away so you can fix and retest quickly. Witnessing on request.

As quoted

Report Review

We check the report against the standard and the authority it’s for before you submit it, then help with the next filing.

On completion

Why Bizpro

Why manufacturers use us for medical device testing

Right Lab, First Time

We match your tests to a lab whose accreditation scope actually covers them, so the report is accepted by BIS, TEC, CDSCO, RDSO, a buyer or a tender committee.

One Point of Contact

Test plan, quotes, samples, follow-ups and report review are handled by one specialist, not passed between lab departments.

Testing Linked to Certification

Reports are planned for the approval you need next, from BIS and TEC to CE and FCC, so you don’t pay to test twice.

Pan-India Support

Medical device testing for businesses across India

We work with CDSCO-registered and NABL-accredited medical device labs across India, and support manufacturers in medical device parks and clusters, including:

Delhi NCRNoidaGurugramFaridabadMumbaiPuneAhmedabadVadodaraBengaluruChennaiHyderabadKolkataJaipurChandigarhLudhianaKanpurCoimbatoreand every other city

Avoid Delays

Common medical device testing mistakes

No Biological Evaluation Plan

Running every ISO 10993 test is costly; skipping one CDSCO expects causes queries. Plan first.

Lab Not Registered for Your Device

CDSCO lab registrations list specific devices and tests. Check before sending samples.

Testing Pre-Production Units

Samples must represent the final design, materials and sterilisation process.

Shelf Life Without Ageing Data

A claimed shelf life needs accelerated ageing and packaging integrity data to back it.

More Testing Services

Other testing we arrange

Electrical Testing

Safety, performance, temperature rise, IP and type tests for electrical products. See Electrical Testing.

Chemical Testing

RoHS, REACH, heavy metals, composition, water and material analysis. See Chemical Testing.

EMC Testing

Emission and immunity testing to CISPR, IEC 61000, MIL-STD-461 and railway EMC. See EMC Testing.

ASTM Testing

Mechanical, material, coating, packaging and petroleum tests to ASTM methods. See ASTM Testing.

NABL / ILAC Accredited Testing

Accredited reports accepted by Indian regulators and overseas buyers. See NABL / ILAC Accredited Testing.

Client Specification Testing

Testing to your tender, OEM, RDSO or MIL-STD-810 specification. See Client Specification Testing.

Quick Answers

Common questions about medical device testing

Which medical device tests does CDSCO require?

CDSCO asks for evidence that a device meets the relevant standard and is safe and performs as intended, usually test reports for electrical safety and EMC (IEC 60601), biocompatibility (ISO 10993), sterility and packaging, and device-specific performance. The exact tests depend on the device, its class and the standards it follows.

Which labs can test medical devices for CDSCO?

CDSCO registers medical device testing laboratories under Chapter X of the Medical Devices Rules, 2017, granting registration in Form MD-40 for specified devices and tests. NABL-accredited labs and government labs are also used. We check that the lab's registration or scope covers your device and tests.

What is IEC 60601-1 testing?

IEC 60601-1, adopted in India as IS 13450 (Part 1), sets the general requirements for basic safety and essential performance of medical electrical equipment. It's used with its collateral standards, such as IEC 60601-1-2 for EMC, and device-specific particular standards.

What is ISO 10993 biocompatibility testing?

ISO 10993 is the series of standards for the biological evaluation of medical devices. Depending on body contact and duration, it typically includes cytotoxicity, sensitisation, irritation and sometimes systemic toxicity, implantation, haemocompatibility and chemical characterisation.

Do I need a test licence to test a medical device?

To make or import small quantities of an unapproved device purely for testing, evaluation or clinical investigation, the Medical Devices Rules provide test licences from CDSCO. We advise whether your situation needs one before samples are made or shipped.

How long does medical device testing take?

Electrical safety and EMC typically take two to five weeks. Biocompatibility ranges from about two weeks for cytotoxicity to several months for longer-term studies. Accelerated ageing depends on the shelf life claimed.

Can foreign test reports be used for CDSCO?

Reports from accredited labs abroad are often submitted with import licence applications. CDSCO can still ask for testing in India, so we review your existing reports against Indian requirements first.

Get your medical device testing planned properly

Tell us the product and the standard or approval it’s for. We’ll confirm the tests, lab, total cost and turnaround in writing, free.

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