The Ministry of Health and Family Welfare has proposed reforms to the Medical Devices Rules, 2017, through the draft Medical Devices (Amendment) Rules, 2026, dated 23 June 2026 and notified vide G.S.R. 515(E). The draft does not touch the substantive compliances that govern how a medical device is designed, manufactured, or quality checked. The draft is aimed at shortening the procedural aspect: the number of days a licensing authority has to scrutinise an application, assign a Notified Body, complete an audit or inspection, and finally grant a manufacturing licence. For an industry that has long treated the licensing calendar as a fixed cost of doing business in India, that compression is the story worth analysing.
This article walks through each proposed change, sets it against the existing timeline it replaces, and considers what the shift means operationally for manufacturers, Notified Bodies, and licensing authorities alike.
Why CDSCO Is Compressing Licensing Timelines?
Regulatory timeline reform of this kind rarely happens in isolation. It tends to follow sustained feedback from industry that licensing delays, rather than substantive non-compliance, are the binding constraint on getting a compliant device to market. The draft Medical Devices (Amendment) Rules, 2026 reads as a direct response to that feedback. Read together, the amendments signal that the government wants faster market access for medical devices without diluting the audit and inspection regime that protects patient safety.Background: The Framework Under the Medical Devices Rules, 2017
Under the Medical Devices Rules, 2017, manufacturing licences are issued according to the risk classification of the device. Class A and Class B devices, considered low and low-moderate risk respectively, are licensed by the State Licensing Authority (“SLA”). Class C and Class D devices, considered moderate-high and high risk respectively, fall under the Central Licensing Authority (“CLA”). The draft amendment leaves the classification system and the QMS standard untouched. It intervenes only in the sequence of dates within Rules 20, 21, 23, and 25 that together determine how long an applicant waits for a decision.Rule-by-Rule Analysis of the Proposed Medical Devices (Amendment) Rules, 2026
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Class B Devices: A 30-Day Scrutiny Window Under Rule 20(5)
Rule 20 governs applications for the manufacture for sale, or distribution of Class A and Class B medical devices. The draft substitutes sub-rule (5) to impose a firm 30-day window within which the SLA must scrutinise a Class B application and assign it to a Notified Body. If the SLA finds rectifiable deficiencies during scrutiny, the 30-day clock resets and starts again from the date those deficiencies are cured. An applicant now knows, in principle, exactly when assignment to a Notified Body should occur, and precisely which event restarts the clock if the application requires correction. -
Audit and Reporting Timelines Under Rule 20(6)
The most significant change is in Rule 20(6)(i). Under the existing rule, a Notified Body has 90 days from the date of application to complete its audit. The draft modifies this in a two-fold manner: first, it cuts the time from 90 days to 30 days. Second, it shifts the trigger for the timeline from the date of application filed by the manufacturer to the date the application is assigned to the Notified Body. That is a double tightening. Not only is the audit window itself shorter, but it no longer includes the time the SLA takes to complete scrutiny and assignment, since that period is now governed separately under Rule 20(5). A new Rule 20(6)(i)(a) has also been inserted to address non-conformance with QMS requirements found during the audit. It requires the Notified Body to complete compliance verification within 20 days of receiving the manufacturer’s compliance report. Previously, no defined timeline governed this step, which meant that closing out an audit finding was subject to the Notified Body’s discretion. The amendment also shortens the timeline under Rule 20(6)(ii) for the Notified Body to submit its final report and recommendations to the SLA, from 30 days to 15 days after audit completion. Taken together, these changes compress a process that could previously stretch past 150 days (a 90-day audit plus a 30-day reporting window, before even accounting for non-conformance closure) into a substantially tighter sequence of defined windows. -
Class C and D Devices: Scrutiny Cut to 30 Days Under Rule 21(4)
For Class C and D devices, which fall under the CLA, the existing Rule 21(4) allowed 45 days for scrutiny of the application from the date of online submission. The draft reduces this to 30 days. As with Class B, this change touches only the administrative review stage. It does not alter the underlying documentary or technical requirements an applicant must satisfy to pass scrutiny. -
Class C and D Devices: Inspection Timeline Reduced Under Rule 23(1)
Rule 23(1) currently prescribes a 60-day window from the date of application for inspection of the manufacturing site. This inspection must be carried out by a team of at least two medical device officers (potentially including a senior officer or subject expert) or by a Notified Body. The draft trims this to 55 days. The five-day reduction is modest compared to the changes elsewhere in the draft, but it should be read alongside the shortened Rule 21(4) scrutiny window. Together, they compress the combined scrutiny-plus-inspection period for Class C and D applications by a full 20 days. -
A New Non-Conformance Timeline Under Rule 23(3)
The draft inserts an entirely new sub-rule, Rule 23(3). It requires the inspection team to complete compliance verification within 15 days of receiving the manufacturer’s compliance report. The timeline applies where a QMS non-conformance has been found during inspection. This provision mirrors the equivalent change made for Class B devices under Rule 20(6)(i)(a) and is one of only two new obligations introduced by this draft, rather than a shortened version of an existing one. Before this amendment, there was no fixed timeline for closing out a non-conformance identified during a Class C or D inspection. -
Faster Grant of Manufacturing Licence Under Rule 25(1)
Rule 25(1) governs the final decision stage. On receipt of the inspection report, and after conducting an enquiry if required, the CLA may grant a manufacturing licence in Form MD-9, grant a loan licence in Form MD-10, or reject the application with reasons recorded in writing. The existing rule allows 45 days from receipt of the inspection report for this decision. The draft reduces that window to 20 days, more than halving the time available for the final determination.
Timeline Comparison: Existing Regime Versus Proposed Regime
The table below sets out each proposed change against the timeline it replaces.| Rule | Stage | Device Class | Existing Timeline | Proposed Timeline |
|---|---|---|---|---|
| 20(5) | SLA scrutiny and assignment to Notified Body | Class B | Not separately defined | 30 days (resets when deficiency in application is cured) |
| 20(6)(i) | Notified Body audit | Class B | 90 days from application | 30 days from assignment |
| 20(6)(i)(a) | Non-conformance compliance verification | Class B | Not defined | 20 days from receipt of compliance report (new) |
| 20(6)(ii) | Notified Body final report to SLA | Class B | 30 days after audit | 15 days after audit |
| 21(4) | CLA scrutiny | Class C and D | 45 days from submission | 30 days from submission |
| 23(1) | Inspection of manufacturing site | Class C and D | 60 days from application | 55 days from application |
| 23(3) | Non-conformance compliance verification | Class C and D | Not defined | 15 days from receipt of compliance report (new) |
| 25(1) | Grant or rejection of licence | Class C and D | 45 days from inspection report | 20 days from inspection report |
What the Medical Devices (Amendment) Rules, 2026 Signal for Manufacturers?
Three observations follow from reading these changes as a set rather than individually. First, the amendment is procedural, not substantive, and that distinction matters for how manufacturers should prioritise their compliance effort. No new technical standard, no new testing requirement, and no new labelling obligation has been introduced for Class B, C, or D devices by this draft. The entire reform operates on the calendar. This means the compliance burden a manufacturer already carries under the Fifth Schedule QMS requirements and applicable device standards is unchanged; what changes is the amount of time available to fix problems once an application is in motion. Second, the shift in the Class B audit timeline trigger, combined with the shortened SLA scrutiny window under Rule 20(5), suggests an intent to make each stage of the process independently accountable. Under the existing framework, a slow SLA scrutiny process could quietly eat into the time notionally available for the audit. Under the draft, each stage carries its own defined window, which, in principle, make delays easier to attribute and address. Third, the introduction of fixed non-conformance closure timelines under new Rules 20(6)(i)(a) and 23(3) is arguably a more consequential change for manufacturers. A manufacturer that receives an audit or inspection finding now has 20 days for Class B and 15 days for Class C and D devices, within which the Notified Body or inspection team must close out its verification once the manufacturer has responded. That gives an incentive on having a rectification process that can be mobilised quickly, since the timeline on the regulator’s side starts only once the manufacturer’s compliance report has been submitted. As the notification is still in a draft form, stakeholders may submit objections or suggestions before the expiry of the 30-day period.This post is contributed by:
Srishti Sharma
Legal AssociateSanjay Kumar
Counsel – Pharma and HealthcareAbout K&G Techlaw Partners:
As a leading healthcare tech law firm in India, we specialize in corporate, commercial and tech law with a special focus on pharmaceutical, healthcare and lifesciences. We provide pharmaceutical legal and regulatory compliance support, healthcare legal advisory, and general corporate consultations. As a trusted CDSCO legal consultant India, we assist pharmaceutical and healthcare companies in navigating complex policy shifts, legal amendments and regulatory enforcement matters.FAQs
No. G.S.R. 515(E) is currently only a draft notification. It was published on 23 June 2026 with a 30-day window for objections and suggestions from the public. The amendment will take effect only from the date of its final publication in the Official Gazette, and its provisions may still change based on comments received.
Two new provisions have been proposed by way of this amendment. Rule 20(6)(i)(a) for Class B medical devices and new Rule 23(3) for Class C and D medical devices introduce a defined timeline, 20 days and 15 days respectively, within which compliance verification must be completed once a manufacturer submits its response to a QMS non-conformance found during audit or inspection. Previously, no such timeline existed for either device category.
Comments may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, C Wing, First Floor, Kartavya Bhavan 1, New Delhi 110001, or emailed to drugsdiv-mohfw@gov.in.
The draft notification is silent on applications already in process. Amendments of this nature typically apply prospectively from the date of final publication unless the final notification expressly states otherwise. This is exactly the kind of ambiguity that manufacturers may want to flag as a suggestion during the 30-day comment window, so that the final rules clarify the treatment of pending applications.
No. The Fifth Schedule QMS requirements and the applicable device standards referenced under Rule 20(5A) remain in their existing form. The draft amendment reduces the time available to licensing authorities and Notified Bodies to scrutinise, audit, and inspect against those existing standards. It does not raise, lower, or otherwise alter the substantive compliance bar itself.
The draft amendment affects the licensing timelines for Class A and B devices under Rule 20 (SLA jurisdiction) and Class C and D devices under Rules 21, 23, and 25 (CLA jurisdiction). Class A devices, typically registered rather than licensed in the same manner as Class B, C, and D devices, are referenced in Rule 20 but are not the primary focus of the timeline reductions described in this analysis.
