India · Certification
ISO 13485 certification in India
Achieve ISO 13485 certification in India with Sterling: 8,100+ client engagements in 60+ countries, 20+ years.
- Accredited certification
- Mumbai office team
- Effivity software included
- Academy training included
Who asks for ISO 13485 in India
Clients include
ISO 13485 certification in India at a glance
One Indian instrument bears on ISO 13485. It does not name the standard. So why do buyers in India keep asking for the certificate?
Medical device manufacturing is licensed under the Medical Devices Rules, 2017, which require manufacturers to meet the quality management system set out in the Rules' Fifth Schedule; for Class A and Class B devices, only Notified Bodies registered with CDSCO audit the manufacturing site, and importers submit a quality certificate against the Fourth Schedule. CDSCO's FAQ does not name ISO 13485, yet the standard is the QMS benchmark that overseas regulators and customers recognise, so one system can be designed to meet both, with a mapping kept as evidence. Certification to ISO 13485 is granted by an accredited certification body: NABCB's APAC recognition includes medical device quality management systems, and NABCB lists CDSCO among the regulators relying on its accreditation. The Bureau of Indian Standards also certifies to IS/ISO 13485. Sterling's Navi Mumbai office builds design controls, risk management, supplier qualification and device files with the client's team, with Effivity and Sterling Academy included. The local route and common questions follow.
Who needs ISO 13485 in India, and what happens without it
In India the question rarely comes from a law. It comes from the buyer, the regulator or the partner that wants proof before it signs. These are the organisations that get asked.
- Medical device manufacturers licensed under MDR-2017Manufacturers must meet the Fifth Schedule QMS; Class A and B sites are audited by CDSCO-registered Notified Bodies.
- Importers of medical devicesImporters submit a quality certificate conforming to the QMS per the Fourth Schedule.
- Contract manufacturers and component suppliersCDSCO expects component makers to qualify product standards and a QMS.
- Device exportersOverseas regulators and customers recognise ISO 13485 as the QMS benchmark.
Not sure which of these applies to you?Answer a short set of questions and your readiness report arrives by e-mail.
Take the ISO 13485 readiness checkISO 13485 requirements in India
Strip away the vocabulary and ISO 13485 requires a company to prove six things about making medical devices that are safe and work as intended.
In India these six sit alongside the local laws and regulations listed under drivers below; one system can evidence both. The detail is on the global hub: ISO 13485 explained →
How to get ISO 13485 certified in India
One team from the Mumbai office carries the work from scoping to certificate. Across India from the Navi Mumbai office: on-site in Mumbai and the Mumbai Metropolitan Region, on-site or remote for other states; remote delivery for distributed teams.
- Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
- Gap assessment against ISO 13485 and the Indian requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
- Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
- Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before the certification body arrives.
- Certification body stage 1 and stage 2, then surveillanceAn accredited body audits and decides. Sterling supports the audits and the three-year cycle.
- End to end, from one team
- Effivity ISO & GRC software
- Preferential Sterling Academy access, with complimentary awareness training for your people
- Internal auditor training for your audit team, as applicable to your standard
- Vulnerability assessment on ISMS engagements
The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.
How long does ISO 13485 certification take in India?
There is no standard duration: it depends on your scope and on how much of the system already runs. In India these are the factors that set the timeline.
- Device class and the CDSCO licensing route running in parallel
- Design and development files and risk management evidence
- Supplier and component qualification
- Certification body scheduling around festival holidays
Sterling agrees a dated plan with you on the discovery call, once the scope is known.
How much does ISO 13485 certification cost in India?
The cost has two parts: the consulting work to build and prove the system, and the certification body’s audit fees, which are quoted separately. In India these factors move both.
- Number of device families and sites
- Certification body audit fees quoted separately from consulting
- Sterilisation, cleanroom or special-process validation needs
- Mapping between the Fifth Schedule and ISO 13485
Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.
ISO 13485 consultants and certification bodies in India
Two different organisations are involved. A consultant helps you build the system and prove it works; an accredited certification body then audits or assesses it and decides. Keeping the two separate is what makes the result credible to buyers and regulators.
- Check that the body’s accreditation or approval covers ISO 13485 and your sector, and that its certificates can be verified online.
- Ask the consultant how the local requirements in India are mapped into the same system, so nothing runs twice.
- Ask for client references in your sector; Sterling’s client letters are available on request.
- Agree who owns the evidence and the tool after the engagement; with Sterling the system stays yours, in Effivity.
Laws and regulations that drive ISO 13485 in India (3)
| Instrument | How it treats the standard |
|---|---|
| Medical Devices Rules, 2017 — CDSCO FAQ (CDSCO/FAQ/MD/01/2024) | Expected in practice QMS per the Fifth Schedule for manufacturers; Notified Body audits for Class A and B; ISO 13485 not named in the FAQ. |
| NABCB APAC MRA certificate — Medical Device Quality Management Systems sub-scope | Accreditation NABCB is an APAC MRA signatory for MDQMS; CDSCO is listed among regulators relying on NABCB accreditation. |
| Bureau of Indian Standards — systems under certification | Market driver BIS lists IS/ISO 13485 among the systems it certifies as a certification body; no mandate. |
"Expected in practice" means the instrument asks for the outcomes ISO 13485 covers without naming a standard, and ISO 13485 is what buyers and regulators commonly accept as evidence of them.
Accreditation, audit language and remote audits in India
Use a certification body accredited for this standard by NABCB or by another accreditation body within the international mutual recognition arrangements (Global ACI — Global Accreditation Cooperation Incorporated, formerly the IAF MLA); check that the accreditation scope covers the standard and your sector. No body is named here unless its accreditation scope has been verified. Edition and transition details: ISO 13485 hub →
Audit language
English audits are the norm; agree interviews in Hindi or the state language, any interpreter and the document language with the certification body at application.
Remote and on-site
Remote audit elements are at the certification body's discretion under its accreditation rules; operational sites are normally visited on-site.
ISO 13485 in India: questions clients ask
Does CDSCO require ISO 13485 certification?
The CDSCO FAQ does not name ISO 13485. Under the Medical Devices Rules, 2017, manufacturers must meet the quality management system requirements of the Fifth Schedule. ISO 13485 is a common way to organise that system, but confirm with CDSCO or your Notified Body what evidence your device class needs.
Who audits Class A and B manufacturing sites?
Notified Bodies registered with CDSCO audit Class A and Class B manufacturing sites, according to the CDSCO FAQ on the Medical Devices Rules, 2017. Importers separately submit a quality certificate showing conformity with the quality management system under the Fourth Schedule. Check the Rules for your device class.
Which accreditation should an ISO 13485 certification body hold?
Look for accreditation covering medical device quality management systems. NABCB states it is a signatory to the international arrangements for that scope, and CDSCO is listed among regulators relying on NABCB accreditation. Confirm that your certifier's accreditation scope covers ISO 13485 and your device sector before you contract.
More on ISO 13485 for Indian organisations
Other standards Indian businesses ask Sterling for
Organisations in India often combine ISO 13485 with one of these, under one management system where the scopes allow.
Start with a free discovery call from the Mumbai office
A Sterling consultant goes through your entities, your regulators and your target date with you. No proposal until the scope is agreed.
Sources
- Medical Devices Rules, 2017 — CDSCO FAQ (CDSCO/FAQ/MD/01/2024) — cdsco.gov.in (accessed 5 Oct 2026)
- NABCB APAC MRA certificate — Medical Device Quality Management Systems sub-scope — nabcb.qci.org.in (accessed 5 Oct 2026)
- Bureau of Indian Standards — systems under certification — bis.gov.in (accessed 5 Oct 2026)
- National Accreditation Board for Certification Bodies (NABCB) — nabcb.qci.org.in (accessed 5 Oct 2026)
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