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India: CE‑Certified Products May Be Exempt From Local Clinical Trials! Which Products Require BIS Certification?

Time：2026-09-01 11:32:46

On August 14, 2026, India’s Ministry of Health and Family Welfare issued two official notifications in succession, formally releasing the Medical Devices (Third Amendment) Rules, 2026 (G.S.R. 744 (E)), introducing critical revisions to the long‑standing Medical Devices Rules, 2017. The Third Amendment (G.S.R. 744 (E)) directly revises rules for clinical investigation exemptions, quality management‑system requirements and testing regulatory frameworks. It marks another major regulatory upgrade following risk‑based classification registration for medical devices in India, and will exert direct impacts on domestic and foreign enterprises targeting the Indian market.

一、Core Regulatory Framework for Indian Medical Devices

India’s statutory regulatory authority for medical devices is the Central Drugs Standard Control Organization (CDSCO), whose primary governing document is the Medical Devices Rules, 2017.

Medical devices are classified into four risk‑based categories: A, B, C and D, subject to tiered registration controls. Higher‑risk classes face stricter registration requirements, ranging from simple notification to full technical review and clinical trial mandates. All medical devices sold or imported into India must complete CDSCO registration corresponding to their risk class.

Prerequisites for market access / Registration basis: CDSCO requires Free‑of‑Sale Certificates from the country of origin and reference regulatory jurisdictions, as well as ISO 13485 certification.

Authorization‑holder requirement: Non‑Indian overseas manufacturers cannot submit registration applications directly. Applications must be filed via an Authorized Indian Representative (AIR), who acts as the sole communication liaison between overseas manufacturers and Indian regulators.

二、Four Key Revisions Under the Third Amendment

Major adjustments are concentrated in four core provisions.

（一） Major Update to Rule 63: EU Added to the Clinical‑Investigation Exemption Whitelist

This is the most widely‑watched revision and brings the biggest policy relaxation for innovator device enterprises.

Per the regulatory text：The list of recognized regulatory jurisdictions under Rule 63 has been expanded to include the European Union, alongside the United States, the United Kingdom, Australia, Canada and Japan.

Scope of application：For new products with no comparable predicate device already marketed in India, manufacturers holding marketing approvals from any of the above‑listed jurisdictions may apply for exemption from local Indian clinical‑study requirements.

Important note：This is not an unconditional full clinical exemption. Enterprises must satisfy four pre‑conditions:

Provide real‑world safety data demonstrating at least two years of EU market‑access history for the product;
Submit a complete Clinical Literature Assessment (CLA) report;
Conduct a population‑difference analysis comparing Indian and source‑country populations to demonstrate safety and efficacy for Indian patients;
Furnish a written commitment for post‑market clinical follow‑up and accept CDSCO post‑market surveillance.

Industry impact: EU‑CE‑certified manufacturers face substantially lowered barriers to Indian market entry. For innovative medium‑ and high‑risk devices in particular, burdensome local Indian clinical trials may be avoided, significantly shortening time‑to‑market.

（二）Class A Low‑Risk Devices: QMS Requirements Formalized Within Self‑Declaration Provisions

Compliance thresholds are implicitly raised for non‑sterile, non‑measurable (NSNM) Class A devices, the lowest‑risk category.

Previous rules：Class A device marketing required only manufacturer self‑declaration of compliance with product standards, with no explicit quality‑management‑system obligation.

Revised rules：Self‑declaration now covers both product standards and quality‑management systems (QMS).

Official interpretation：CDSCO does not currently mandate submission of ISO 13485 certificates or third‑party audits for Class A devices. Nevertheless, enterprises must establish rule‑aligned QMS processes and maintain complete quality documentation, production records and traceability evidence. Regulators reserve the authority to conduct post‑market inspections and impose penalties for non‑compliance.

Industry impact：Implicit compliance costs rise for low‑risk devices. Pure‑trading and OEM‑labeling enterprises should complete QMS documentation promptly to avoid non‑compliance findings during official audits.

（三） Clarified Testing Regulatory Framework: Formal Naming and Defined Mandates for Government‑Run Testing Laboratories

Rule 19 has been formally retitled Government Medical Device Testing Laboratories.

This revision does not impose new testing obligations. It codifies the status, responsibilities and procedural boundaries of official testing laboratories at statutory level.

Together with the Ninth Schedule introduced under the concurrent Second Amendment, India has implemented unified fees for medical‑device testing and review, with an automatic annual fee increase of 5 %. This eliminates inconsistent pricing practices across different authorities in the past.

Industry impact：Enterprises can better forecast testing costs and timelines, improving certainty for registration project planning.

（四）Technical Statutory Adjustments: Cross‑Reference Alignment

The amendment also corrects cross‑citation numbering across provisions to eliminate interpretive ambiguities caused by misaligned clause references; these are routine technical refinements to the regulatory system.

三、Mandatory BIS Certification Requirements for Medical Devices

Many enterprises mistakenly believe CDSCO registration alone suffices for medical‑device market access. In fact, as India’s Quality Control Orders (QCO) keep expanding, numerous medical‑device product categories fall under mandatory BIS certification requirements. BIS certification runs parallel to CDSCO registration; both are compulsory for market entry.

（一）Which medical devices require mandatory BIS certification?

All active medical devices powered by external AC‑DC power adapters (e.g., IPL hair‑removal devices, medical aesthetic equipment, electrocardiogram diagnostic devices etc.). Their accompanying power adapters fall under the mandatory list administered by India’s Ministry of Electronics and Information Technology (MeitY) and must obtain BIS CRS registration under Scheme‑II.

（二）Key Notes for BIS Certification

Certificates are factory‑specific: BIS certificates are issued to actual manufacturing facilities only, not to importers or traders. Overseas factories must appoint an Authorized Indian Representative (AIR) for applications.
Local‑lab testing mandate: Samples must be tested at BIS‑recognized laboratories located within India; overseas‑lab test reports are not directly accepted.
Customs‑clearance risks: Once QCO provisions take effect, shipments lacking valid BIS certification risk customs detention or return‑to‑origin.

四、Practical Operational Guidance for Export‑Oriented Enterprises

Evaluate exemption pathways for EU‑certified products：Map your CE‑certified product portfolio. For products eligible under Rule 63, plan registration via clinical‑exemption routes. Complete population‑difference analyses and formalize post‑market clinical commitments well in advance.

Class A enterprises: complete QMS documentation：Establish QMS documentation aligned with regulatory requirements, and retain full‑chain production, quality‑control and traceability records to prepare for post‑market regulatory inspections.

Simultaneously verify BIS‑certification obligations：Prioritize checking CRS‑certification obligations for power‑supply accessories. Cross‑reference finished devices against the latest QCO catalogue to identify BIS‑certification obligations and prevent customs detention due to missing certifications.

Plan for cost‑and‑timeline volatility：Factor in unified fee schedules from the Ninth Schedule, including the 5 % annual upward fee adjustment. Where feasible, select Indian laboratories accredited by both CDSCO and BIS to reduce duplicate testing expenditures.

五、Conclusion

India’s medical‑device regulatory landscape is undergoing rapid evolution. On one hand, simplified market‑access pathways aligned with mature global regulatory systems attract innovative products. On the other hand, baseline compliance requirements are tightening via QMS mandates, labeling rules and expanding QCO‑driven BIS‑certification scope. For overseas exporters, understanding the underlying regulatory logic behind these amendments and early proactive compliance will support smooth market entry into India’s fast‑growing medical‑device market. For further inquiries, please contact Wiselink.

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