Why Class B vs Class C is not just a classification label
Under India’s Medical Devices Rules, 2017, the distinction between Class B and Class C medical devices is not cosmetic. It directly determines who reviews your application, how deeply your test evidence is examined, and how much justification is required beyond a standard pass report.
Manufacturers often assume that if both Class B and Class C devices reference the same international standards, the testing expectations are equivalent. In practice, the testing rigor gap lies not in the test method itself, but in how the Central Drugs Standard Control Organization evaluates the depth, traceability, and clinical relevance of the evidence.
Misjudging this gap is one of the most common reasons Class C submissions face extended queries or review cycles.
The regulatory divide that drives testing rigor
The primary difference between Class B and Class C devices begins with who evaluates the dossier.
Licensing and review structure
Aspect | Class B | Class C |
Licensing authority | State Licensing Authority | Central Licensing Authority under CDSCO |
Primary reviewer | Notified Body audit | CDSCO medical device officers and subject experts |
Audit emphasis | Quality system and conformity | Safety, performance, and benefit-risk validation |
Typical review depth | Conformity confirmation | Clause-level technical scrutiny |
For Class B devices, the State Licensing Authority typically relies on the conformity assessment performed by a Notified Body. If the audit and test reports are complete and valid, the license is often issued without extensive technical interrogation.
For Class C devices, the Central Licensing Authority directly reviews the technical file. Test summaries are not treated as sufficient evidence. Regulators frequently examine protocols, conditions, deviations, and how failure modes were addressed.
This difference is central to understanding why Class C testing is perceived as more demanding.
Same standards, different depth of evidence
Both Class B and Class C devices may be evaluated against standards such as IEC 60601 or ISO 10993. The distinction lies in how the results are interpreted and challenged.
Electrical safety and essential performance
For Class B devices, regulators usually verify that a valid test report from an accredited laboratory exists and that basic safety requirements are met.
For Class C devices, essential performance becomes a focal point. The Central Licensing Authority expects evidence that the device continues to operate safely during abnormal and single fault conditions. Risk management documentation must clearly map identified hazards to test outcomes.
Manufacturers preparing IEC 60601 submissions often underestimate this linkage. This is why early alignment with the expectations outlined in the IEC 60601-1 compliance guide for medical electrical equipment is important for Class C planning.
Electromagnetic compatibility expectations
For Class B devices, standard immunity levels are typically accepted if no critical performance degradation occurs.
For Class C devices, the intended use environment carries greater weight. Devices used in critical care or life supporting scenarios are assessed more conservatively. Any degradation during immunity testing must be justified with clear clinical reasoning and documented risk controls.
This is where early exposure to test conditions through pre-compliance EMC testing can help teams identify vulnerabilities before formal evaluation.
Biocompatibility scope expansion
Class B devices with limited patient contact often rely on a narrow biocompatibility scope supported by literature and historical use.
Class C devices more frequently involve prolonged, invasive, or systemic exposure. Regulators may request broader testing justification and stronger material safety rationale. Literature alone is less likely to be accepted without supporting chemical or toxicological analysis.
Software validation is where the gap widens fastest
As devices incorporate more software driven functionality, software validation has become a major differentiator between Class B and Class C scrutiny.
For Class B devices, documentation often focuses on functional verification and basic architectural description.
For Class C devices, the Central Licensing Authority expects a complete software lifecycle view. This includes requirements for traceability, verification evidence, and validation that software driven functions remain safe under fault or abnormal conditions. For devices making diagnostic or therapeutic decisions, algorithm validation and data integrity become critical review points.
Connected Class C devices are increasingly expected to demonstrate cybersecurity risk awareness and mitigation as part of overall safety justification.
Clinical evidence expectations differ materially
Clinical evidence is another area where Class B and Class C submissions diverge.
Class B devices often rely on substantial equivalence supported by literature and market history.
Class C devices may still reference predicate devices, but regulators frequently expect stronger performance evaluation data. For life sustaining or novel technologies, additional clinical justification is common. Even when international approvals exist, Indian regulators may request clarification if patient demographics or environmental conditions differ.
Understanding this expectation early helps avoid late stage clinical queries during CDSCO review. The broader framework is explained in the CDSCO approval process for medical devices in India.
Laboratory selection becomes strategic for Class C devices
For Class B submissions, most accredited laboratories can produce acceptable test reports if scope coverage is correct.
For Class C submissions, laboratory choice directly affects review outcomes. Regulators expect reports that are clearly structured, clause mapped, and aligned with the Essential Principles checklist.
Manufacturers often benefit from working with laboratories that understand how test evidence is consumed during Central Licensing Authority review rather than treating reports as generic certificates. This distinction is discussed further in how to choose the right medical device testing laboratory and what differentiates an accredited medical device testing laboratory.
Where Astute Labs fits in
Class B and Class C devices may reference similar standards, but the regulatory scrutiny applied by CDSCO differs significantly. Astute Labs supports manufacturers by aligning test strategies and report structure with CDSCO’s risk based expectations through medical device testing services and supporting system robustness through EMI and EMC testing services.
This approach helps reduce avoidable technical queries during Central Licensing Authority review. Contact us
