NABL CDSCO MD-40 ISO 10993 Medical Devices Rules 2017

Medical Device Testing Laboratory India | ISO 10993 | NABL and CDSCO Accredited

From biocompatibility to sterility validation — NABL-accredited testing at Delhi and Bahadurgarh with CDSCO MD-40 approval at both locations.

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The Challenge

Medical device manufacturers face a dual compliance burden: CDSCO registration under the Medical Devices Rules 2017 requires specific Indian test data while international buyers expect ISO 10993 compliant biocompatibility reports — finding a lab that meets both without splitting across vendors is the core problem.

Our Approach

Auriga holds CDSCO MD-40 approval at Delhi and Bahadurgarh and runs ISO 10993 series testing under NABL accreditation — one organisation, one quality management system, one set of reports accepted by CDSCO and international buyers.

What We Test for Medical Devices

Biocompatibility Testing

ISO 10993 Series

Cytotoxicity, sensitisation, irritation, and systemic toxicity — required for all CDSCO device registrations and international submissions.

Bioburden and Sterility Testing

ISO 11737-1 and ISO 11737-2

Microbial load quantification and sterility confirmation — critical for Class B and C device manufacturers and sterilisation validation.

ETO Residuals and Packaging Validation

ISO 10993-7 and ISO 11607:2019

ETO, ECH, EG by GC-FID and seal strength plus accelerated ageing by ASTM F88 and F1980 — sterilisation residuals and packaging integrity.

Extractables, Leachables and Particulate Matter

ISO 10993-18:2020 and USP <788>

Chemical entities migrating from device materials and sub-visible particles by ICP-MS — chemical characterisation per the 2020 revision.

Who We Work With

Medical Device Manufacturers

Class A, B, C, and D device makers preparing CDSCO registration dossiers requiring biocompatibility, bioburden, sterility, and packaging validation at pre-submission stage.

Device Importers and Distributors

Companies importing into India requiring CDSCO import registration testing — Auriga MD-40 approval at Delhi and Bahadurgarh means reports are accepted directly.

OEM and Contract Manufacturers

Manufacturers producing for international brands requiring ISO 10993 data for CE marking, FDA 510(k), or TGA submissions — NABL reports accepted under ILAC MRA.

Startups and New Device Developers

Early-stage companies conducting design validation and pre-clinical safety characterisation — phased testing packages sized for pre-revenue timelines.

Why Auriga for Medical Device Testing

CDSCO MD-40 at two labs, the full ISO 10993 series under one accreditation, and NABL reports that travel across 100+ ILAC MRA countries.

CDSCO MD-40 at Two Locations

Delhi and Bahadurgarh — reports accepted directly for CDSCO registration without re-testing at a secondary CDSCO-notified laboratory.

Full ISO 10993 Series in One Organisation

ISO 10993-1 through 23, ISO 11737-1 and 2, ISO 10993-7, ISO 10993-18:2020, ISO 11607:2019 — all in NABL scope, no vendor splitting.

ICP-MS for Elemental Characterisation per ISO 10993-18

5 ICP-MS units at Delhi, Baddi, and Bangalore — ppb-level multi-element analysis for polymers, metals, and coatings.

NABL Results Accepted by ILAC MRA Partners

Accepted in 100+ countries — the same NABL report is usable for CDSCO registration, CE marking, FDA 510(k), and TGA submissions.

Medical Device Testing Services

Drill into the specific test you need — each service page details methods, standards, and turnaround.

Packaging Validation →

Extractables & Leachables →

Blood Bag Testing →

Particulate Matter →

Material Characterisation →

Regulatory Framework for Medical Devices in India

The Medical Devices Rules 2017 (amended 2020) brought all devices under mandatory CDSCO regulation. Class A and B devices require registration. Class C and D devices require clinical investigation data and full safety evidence. Auriga supports manufacturers across all four classes — pre-submission biocompatibility, sterilisation validation, packaging qualification, and chemical characterisation.

For devices targeting international markets alongside India, NABL reports are accepted in the US, EU, UK, Australia, and GCC under the ILAC Mutual Recognition Arrangement — eliminating re-testing at a foreign laboratory. The same Auriga report supports CDSCO registration, CE marking under EU MDR 2017/745, FDA 510(k) submissions, and TGA Australia filings.

Frequently Asked Questions

Which device classes does Auriga test?

Auriga tests all device classes — A, B, C, and D — under CDSCO MD-40 approval at Delhi and Bahadurgarh. The same NABL-accredited platform supports CDSCO registration dossiers across the full risk-classification range, with the test battery scaled to the class and intended use.

Are Auriga reports accepted for CDSCO registration?

Yes. Auriga holds CDSCO MD-40 approval at both Delhi and Bahadurgarh — reports issued from either lab are accepted directly for CDSCO registration under the Medical Devices Rules 2017 without re-testing at a secondary CDSCO-notified laboratory.

Can the same report be used for CE marking or FDA 510(k)?

Yes. Auriga is NABL accredited under ISO/IEC 17025:2017, and NABL is a signatory to the ILAC Mutual Recognition Arrangement (MRA). NABL reports are accepted in EU MDR 2017/745 submissions, FDA 510(k) filings, TGA Australia, and 100+ ILAC MRA partner countries without re-testing.

How long does a full biocompatibility package take?

Indicative turnaround is 21 to 30 working days for a screening package (cytotoxicity, sensitisation, irritation). Full ISO 10993 characterisation including systemic toxicity, implantation, genotoxicity, and chronic studies requires additional time. Exact timelines are confirmed at quote stage based on the device class, intended use, and full test scope.

Does Auriga test blood contact devices?

Yes. Haemocompatibility per ISO 10993-4 is within scope. Blood bag testing per IS 12065 and ISO 3826 is performed at Delhi and Bahadurgarh under CDSCO MD-40 approval — supporting both CDSCO blood bag registration and international compliance.

What sample quantity is required?

Sample quantity varies by device type, test scope, and the specific ISO 10993 series tests selected. We do not state a fixed quantity on this page because under-sampling leads to project delays. Confirm exact sample quantity with your Auriga SPOC at quote stage — we will size the request to the agreed test battery.

Need medical device testing for CDSCO registration or international market entry?

Auriga holds CDSCO MD-40 approval at Delhi and Bahadurgarh with the full ISO 10993 series under NABL accreditation. Share your device class, sterilisation route, and target markets and our medical device team will respond within 24 hours.

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