Law Updates

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Summary: In June 2026, the government proposed a change to the Medical Devices Rules, 2017. The main goal is to make the process of getting a medical device license in India faster and easier. At the same time, the rules still keep safety and quality checks in place. This change helps companies that need a medical device manufacturing license or a medical device import license because it shortens the waiting time for approval. But it also means companies must keep better records and watch their products more closely after they are sold, which is often called post-market surveillance. The exact wording of the new rule is not public yet. So this article explains what usually happens when governments make medical device registration and licensing faster, and how such changes affect businesses across the healthcare sector. Big-Picture Impact on Businesses in India Faster and clearer licensing under the Medical Devices Rules usually changes business in four big ways. Companies applying for a CDSCO medical device license or planning medical device registration in India should watch each of these closely. Impact Area What It Means for Businesses Reduced time-to-market Shorter review times mean companies get their medical device license sooner. Devices reach hospitals and clinics faster. New companies making diagnostic tools, wearables, and home-care devices benefit the most, since delays can hurt small businesses badly and raise the cost of a slow medical device manufacturing license process. More predictable process Rules usually explain clearly what forms are needed, what data must be shown, and how devices are classified (Class A to D). This helps businesses plan a clear timeline for medical device registration and product launch. Higher expectations for records Faster approval usually comes with stricter checks before submission and standard templates. Companies with strong quality management systems find it easier to follow the rules. Companies with messy paperwork struggle more with medical device compliance. Shift to ongoing checks Instead of doing all checks before giving a license, the government checks products more after they are sold. Businesses must keep watching their products, report problems, and fix issues quickly to keep their medical device license valid. Overall, companies that care about quality gain the most. Companies that relied on slow, unclear rules to hide weak products lose out. Why the Government Is Bringing This Policy Now Several reasons are pushing the government to speed up medical device licensing in India. Reason Explanation Self-reliance in healthcare India wants to make more medical devices at home, from syringes to imaging machines, so it depends less on imports. A faster medical device manufacturing license process supports this goal directly. Lessons from COVID-19 The pandemic showed that slow approval for ventilators, oxygen machines, and test kits can put lives at risk. Long queues for a medical device license are a health problem, not just a business problem. Global competition Indian med-tech companies compete with companies worldwide. They need approval times similar to those in other big markets, or they lose investment and partnerships to countries with faster medical device registration systems. Modern regulation The government is moving medical devices away from old drug-style rules and toward rules based on risk level. Faster licensing is part of this update, alongside stronger post-market checks. This policy is meant to support new ideas and more manufacturing, not to lower safety standards. It moves effort away from slow paperwork and toward smarter, risk-based checking. Who Gets Maximum Benefits? Group How the Change Helps Indian device makers and start-ups Companies making diagnostic tools, surgical tools, implants, disposable items, hospital furniture, home-care devices, and wearables benefit most from shorter approval times for a medical device manufacturing license. Start-ups can also show investors that approval is faster, which helps them raise money. Importers and distributors Businesses bringing in advanced imaging machines, robotic surgery tools, and specialized supplies from countries like the US, EU, and Japan get quicker medical device import license registration and renewal. Hospitals and diagnostic chains Faster licensing gives hospitals more choice of equipment, often at better prices, since more companies can compete. It also helps hospitals offer new types of care, like day surgery and home monitoring. Patients and payers More competition among device makers usually leads to better quality at lower prices, especially for everyday items like syringes and monitors. Regulatory consultants and compliance firms Firms offering medical device regulatory consulting, dossier preparation, and quality system support see more demand as businesses rush to meet new, faster timelines. Who May Be Negatively Impacted or Feel "Losses"? Group Why They May Struggle Companies relying on unclear rules Businesses that used confusing classification or weak paperwork to get by will find it harder to hide problems, since faster screening finds gaps quickly during the medical device registration process. Small importers without strong teams Traders bringing in small amounts of niche devices without a compliance team may struggle with the stricter paperwork and digital filing needed for a medical device import license. Companies that ignore post-sale checks Businesses that do not track complaints, device failures, or safety issues after selling their products will face more trouble, fines, and damage to their reputation. In short, honest, quality-focused companies come out stronger. Companies that depend on slow, unclear systems to avoid scrutiny face more risk and cost. What Was the Requirement for This Policy The rule change is meant to fix several long-standing problems tied to the medical device license in India's processes. Problem Explanation Licensing delays Businesses have long complained that getting a medical device license, especially for higher-risk devices (Classes C and D), can take many months, hurting their plans and delaying medical device registration in India. Confusing process Overlap and unclear roles between the Central Licensing Authority and State Licensing Authorities caused delays and confusion for applicants. Unclear classification Confusion around how devices are placed into Class A, B, C, or D slowed down approvals and caused disagreements between businesses and regulators. Global alignment India is trying to match international standards used by groups like IMDRF, EU MDR, and the US FDA, making the medical device registration system more attractive to global companies. Digital push Moving to online systems, trackable timelines, and standard forms fits with the government's larger goal of making business easier for anyone seeking a medical device license. Impact on India's Economy Positive Impacts Area Expected Benefit Manufacturing and exports Shorter approval times and clearer rules attract more investment into Indian device-making and design. More devices will be built and sold abroad, boosting demand for medical device manufacturing license support. Less dependence on imports A better system encourages local production of items that used to be imported, such as disposables, basic monitors, and diagnostic kits, reducing reliance on a medical device import license pathway. Healthcare quality Better and more available devices in hospitals can improve patient care and make the healthcare system work better overall. New ideas and research Universities and research labs find it easier to turn new inventions into real products, strengthening India's device-making community and creating new demand for medical device registration support. Risks and Limits If licensing becomes too fast without enough checking after sale, unsafe or poorly tested devices could reach the market. Regulators need enough trained staff and good systems to handle the extra workload. Still, the overall economic effect is expected to be positive if the government keeps up its ability to monitor the market and support businesses seeking a medical device license. Is This the Right Decision or an Added Burden? Reasons It Is Largely the Right Decision The change brings India closer to global best practice, using rules based on risk level, clear timelines, and open processes instead of slow, unclear steps. It supports new ideas, investment, and better access to healthcare, especially important in a country that needs affordable medical devices on a large scale. It does not weaken safety; it shifts focus from bureaucratic delay to stronger paperwork and better checking after sale for every medical device license holder. Where Difficulties May Arise Who What They Must Do Businesses Improve internal record-keeping and quality systems, keep track of product safety consistently, and adjust quickly to new forms, timelines, and online systems for medical device registration. Regulators Train staff on new processes and digital tools, and manage a bigger number of applications as approval becomes faster for a medical device license. Conditions for Business Clear guidance, fixed timelines, and risk-based steps make planning and investing easier. Faster licensing lowers uncertainty, making India more attractive for global medical-device partnerships and easier for local firms seeking a medical-device manufacturing license. Transparency Rule changes like this usually spell out clearly what type of application is needed, what each device class requires, and expected timelines, along with how to escalate delays. When paired with online tracking systems, businesses can always see where their medical device registration application stands. Safety and Environment Better classification lets regulators focus more attention on high-risk devices, such as Class C and D items and critical implants, while making the process simpler for low-risk items. Stronger checks after sale and quicker safety corrective actions should improve patient safety overall. Devices that affect the environment, such as single-use plastics or electronic waste, are usually handled by separate environmental rules rather than by this licensing change itself. Compliance and What Businesses Need to Do Although the exact wording of the new rule is not yet public, businesses should prepare to focus on the following steps to secure a smooth medical device license approval. Requirement Details Correct device classification Placing devices in the right class (A to D) and using the correct medical device registration path. Complete documentation Preparing a technical file, clinical or performance evaluation data, risk management and biocompatibility data, and quality system certification such as ISO 13485 certification. Digital filing Submitting and tracking applications through government online portals, keeping timelines in mind. Post-sale monitoring Setting up systems for handling complaints, reporting safety problems, and taking quick corrective action when needed to keep a medical device license active. Companies without an internal regulatory or quality team will likely need outside help from a medical device regulatory consultant to meet these requirements. Opportunities for Corpseed This reform opens strong opportunities for Corpseed to grow its medical device regulatory consulting services and support businesses seeking a medical device license or medical device registration in India. Service Area What It Covers Licensing fast-track consulting Full support for Medical Device Rules, 2017 licensing, including device classification, document preparation, and communication with regulators for a medical device manufacturing license or medical device import license. Regulatory health-check Reviewing existing licenses and paperwork against new requirements, spotting gaps, and creating upgrade plans for current medical device license holders. Start-up medical device packages Tailored support for early-stage companies, including choosing the right pathway, guidance on designing for compliance, and planning for time-to-market. Post-market surveillance and quality system services Building complaint-handling systems, safety corrective action workflows, and full quality system implementation and audits, including ISO 13485 certification support. Training and capacity building Workshops for hospitals, diagnostic chains, manufacturers, and importers on new rules, safety duties, and digital filing for medical device registration. Support for international manufacturers Helping foreign device companies enter the Indian market, including local representation, license applications, and meeting India's quality and safety requirements for a medical device import license.

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Summary: The Formulation of the Intermediate Regulatory Framework in India India's formulation intermediate licensing framework sits at the intersection of two regulatory pillars: New Drugs and Clinical Trials (NDCT) Rules, 2019, under the Central Drugs Standard Control Organisation ( CDSCO ), which govern the approval of New Drugs, including all modified or sustained-release dosage forms. The Drugs and Cosmetics Act and applicable State Rules, under the State Licensing Authorities (SLAs), govern manufacturing licenses for standard, non-new-drug formulation intermediates. CDSCO's clarification, issued via Circular dated 24 June 2026, sits on top of these two pillars and tells manufacturers exactly which pillar applies to which type of intermediate. The formulation intermediate segment is an important part of India's pharma manufacturing chain: Formulation intermediates such as Directly Compressible (DC) granules, taste-masked granules, and modified-release granules/pellets are produced both by API manufacturers moving downstream and by specialised CDMOs. These intermediates feed directly into tableting and capsule-filling operations across India's domestic and export-facing pharma industry. Confusion between Central and State jurisdiction has, for years, led manufacturers to choose licensing routes based on convenience rather than correct classification. What Has Changed in 2026 - The Full Regulatory Clarification 1. New Drugs Including SR/ER/PR/DR Intermediates Now Require CDSCO Approval CDSCO checks the definition of "New Drug" from time to time and applies it strictly. The rule it relies on is Rule 2(1)(w) of the NDCT Rules, 2019 - this rule says that any modified or sustained release form of a drug is automatically treated as a New Drug, no matter how long that drug has been sold in its ordinary form. Here is the key thing: a granule or pellet that was earlier licensed at the State level might now require Central CDSCO approval, even if its active ingredient is decades old. This happens because the release mechanism itself - not the drug molecule - is what triggers New Drug status. With the 24 June 2026 clarification: All SR, ER, PR, and DR dosage forms - including Gastro-resistant Tablets/Capsules and Delayed Release (Enteric Coated) Tablets/Capsules - are deemed New Drugs. This deeming applies equally to the bulk formulation intermediate (the SR/ER/PR/DR granule or pellet itself), not only to the finished tablet or capsule. Manufacturers must file an application for the finished formulation together with a coordinated application for the formulation intermediate, both with CDSCO. 2. Standard Formulation Intermediates Remain on the SLA Track CDSCO has also clarified the other side of the line: Directly compressible granules and standard taste-masked granules that are not New Drugs continue to be licensed by the concerned State Licensing Authority. Applicants must submit the requisite data - stability, impurity, and blend uniformity information - directly to the SLA. 3. The Novel Excipient Override CDSCO has built in one important exception that applies regardless of release profile: If a formulation intermediate, of any kind, contains a new or novel excipient, CDSCO approval becomes mandatory. This overrides the SLA route entirely, even for an otherwise ordinary, immediate-release granule. 4. Single Point of Submission The circular closes by stating that the applicant must submit the application for the formulation intermediate - whether for import, manufacturing, or marketing - to CDSCO or to the SLA, as the case may be, based on the classification above. Implementation Timeline Summary Regulatory Milestone / Event Effective Date Transition Expectation 68th DCC Meeting recommendation on formulation intermediates 20 March 2026 Transition Expectation Official CDSCO Circular notification (F. No. ND-11012(17)/1/2026-eoffice) 24 June 2026 Treated as an immediate enforcement baseline - no formal grace period notified Recommended internal SKU/portfolio audit by manufacturers Immediate No statutory window; self-rectification is advisable before the next inspection Why CDSCO Issued This Clarification - The Core Need 1. Inconsistent State-Level Interpretation Created a Fragmented Market When formulation intermediates first began moving at scale between CDMOs, API makers, and formulation houses, there was no single, uniform understanding of where the SLA's authority ended and CDSCO's began. Because the underlying rule was open to interpretation, different states reached different conclusions for materially similar products. It was like a national vehicle safety authority allowing one state to certify an engine block while another state insisted the same engine needed national approval. Manufacturers found themselves choosing the state with the most convenient interpretation rather than the legally correct one. So the licensing system lost its consistency. The 2026 clarification fixes this by drawing one national line that every state and zonal office must now follow. 2. Therapeutic Risk Tied to Modified-Release Mechanisms Modified-release granules and pellets work because of a polymer coating or matrix structure that controls how and when the drug is released inside the body. Even a small failure in that mechanism at the bulk intermediate stage - before the product is even compressed or filled - can mean: Dose-dumping, where the full intended dose is released far too quickly, which is especially dangerous for narrow-therapeutic-index drugs Bioavailability variance, where batch-to-batch differences in coating change how much drug actually reaches the bloodstream Coating failure during compression or capsule filling, which can compromise the release mechanism before it even reaches finished-product testing CDSCO's job under the NDCT Rules, 2019, is to ensure that any product carrying this kind of therapeutic risk is evaluated centrally, with full clinical and technical scrutiny, rather than locally. 3. Closing the Gap Between API, Intermediate, and Finished Dose Previous regulatory oversight was confined to only the final tablet or capsule product. The actual intermediate drug substance in its bulk SR/ER/PR/DR form – that is, the process wherein the delivery system is made – had somehow eluded the same extent of oversight. This gap is bridged with the 2026 clarification. 4. Protecting the SLA Track From Misuse The novel excipient override has the same reason behind it; an otherwise conventional granule could turn out to be more risky after the addition of an untested excipient. The absence of the override would have made it possible for manufacturers to submit novel granules for approval under the SLA process due to their conventional release pattern. Impact on Indian Pharma Businesses in 2026 1. Large Formulation Manufacturers and CDMOs Modified-Release Portfolio: The companies that have specific multiparticulate or SR/ER pellet production lines will be directly impacted. Now, such companies will have to: Identify all SR/ER/PR/DR SKUs vis-a-vis the new CDSCO requirement Submit dual applications - one for the formulation and one for the intermediate – to CDSCO Re-align their SLA licensing for modified-release intermediates vis-a-vis the CDSCO requirement Standard Granule Portfolio: In the case of DC granules and taste-masked granules, large-scale manufacturers should: Improve upon stability, impurity, and blend uniformity data for a smooth SLA renewal Screen every excipient used across their portfolio for novelty status under Indian regulatory precedent 2. Specialised Pellet and Granule CDMOs This group sits at the centre of the circular's impact. Many CDMOs built their business specifically around multiparticulate SR/ER pellet manufacturing for client formulators. Impact: A CDMO supplying SR or ER pellets under an SLA-only license is now operating outside the correct regulatory channel. Pellets without the correct CDSCO clearance cannot legally be supplied for use in a finished formulation. To continue operating, these CDMOs must: Identify every pellet/granule SKU that falls under the SR/ER/PR/DR or novel excipient category. File the coordinated CDSCO application alongside their client formulator, since the rule expects parallel filing for the intermediate and the finished product. Update batch records to separate intermediate-stage data clearly from finished-dose data There is no formal grace period attached to this clarification, which makes early realignment important. 3. API Manufacturers Moving Downstream A growing number of API manufacturers have begun producing granulated or pelletised intermediates to capture more value in the supply chain. Impact: The moment an API is converted into an SR/ER/PR/DR granule or pellet, the entity is no longer simply an API producer for regulatory purposes - it becomes a formulation intermediate manufacturer. These manufacturers need to assess each downstream product individually against the CDSCO/SLA matrix rather than assuming their existing API manufacturing license is sufficient. 4. Importers of Formulation Intermediates India imports certain specialised pellets, coated granules, and excipient-based intermediates. Impact: Imported SR/ER/PR/DR intermediates require CDSCO clearance before import, manufacturing, or marketing. Importers need to verify, with their overseas suppliers, the declared release profile and excipient composition of every consignment before filing for clearance with the correct authority. 5. Finished-Dose Formulators Procuring Intermediates Externally Formulation houses that buy granules or pellets from third-party CDMOs rather than manufacturing them in-house must: Confirm that every externally sourced intermediate carries the correct license - SLA or CDSCO - before incorporating it into a finished product. Update vendor qualification and supplier audit checklists to specifically capture this classification Recognise that a finished formulation built on an incorrectly licensed intermediate carries the same compliance exposure as the intermediate itself. How Businesses Will Achieve Compliance Phase 1: Portfolio and SKU Classification Review (Do This Now) For each formulation intermediate, check and record: Whether it carries any SR, ER, PR, or DR release function Whether it is gastro-resistant or enteric-coated Whether its formula includes any excipient not previously used in an approved Indian product Compare each SKU against the CDSCO/SLA matrix to determine the correct licensing track Flag any SKU currently held under an SLA-only license that should be on the CDSCO track Phase 2: CDSCO Dual-Application Preparation (Where Needed) Compile release kinetics, dissolution, and stability data for the bulk intermediate Align this data with the finished-formulation dossier, since both applications are evaluated together Submit the coordinated application to CDSCO's New Drugs Division Phase 3: SLA Dossier Strengthening for Standard Intermediates Upgrade stability data, impurity profiling, and blend uniformity reports for DC and standard taste-masked granules File or renew the application with the concerned State Licensing Authority Phase 4: Excipient Novelty Screening Screen each excipient with respect to Indian regulatory precedent of usage, beyond just its worldwide approval. When novelty is established, prepare a safety package for CDSCO assessment Whenever feasible, screen excipient replacement that would maintain the SLA designation Phase 5: Inspection Readiness Amend batch manufacturing logs to differentiate intermediate stage data from final dose data Perform internal mock audits for the CDSCO/SLA classification prior to the next regular audit Benefits for Businesses After Implementation For Compliant Manufacturers and CDMOs Benefit Details Manufacturing Continuity Correctly licensed intermediates are not exposed to show-cause notices, suspensions, or batch seizures during inspection. Client Confidence Formulators can rely on CDMO-supplied intermediates without inheriting hidden licensing risk. Export Credibility A clean CDSCO/SLA compliance record supports export clearance and CoPP applications. M&A and Valuation Protection A documented, correctly classified intermediate portfolio avoids diligence flags during fundraising or acquisition Reduced Enforcement Exposure Proactive realignment avoids reactive remediation under inspection pressure, which is typically costlier and faster-paced For Patients and the Healthcare System Benefit Details Reduced Dose-Dumping Risk Central evaluation of release mechanisms at the bulk intermediate stage reduces the risk of premature or excessive drug release. More Consistent Bioavailability Centrally reviewed SR/ER/PR/DR intermediates are evaluated for batch-to-batch consistency before reaching patients. Greater Confidence in Modified-Release Products A clearer licensing line reduces the chance of substandard modified-release products entering the supply chain through SLA-only routes. Is This the Right Decision or an Additional Burden? Why It Is the Right Decision Aspect Reason Closes a Genuine Regulatory Gap Bulk SR/ER/PR/DR intermediates carry real therapeutic risk that was not consistently scrutinised at the intermediate stage. Restores National Uniformity A single CDSCO/SLA classification line replaces inconsistent state-by-state interpretation. Strengthens the Novel Excipient Safety Net The override ensures untested excipients cannot bypass central safety review by hiding inside a conventional-looking product. Backed by Statutory Definition The clarification applies an existing rule - Rule 2(1)(w) of the NDCT Rules, 2019 - rather than introducing new, untested obligations. Where It Adds Burden Concern Excipient Re-Screening Effort No Formal Grace Period Because the circular is clarificatory, manufacturers do not have a notified transition window before enforcement applies. Dual-Filing Cost and Complexity Coordinated CDSCO applications for both the intermediate and the finished formulation require more data and more time than a single SLA filing. CDMO Realignment Pressure Specialised pellet/granule CDMOs built around SLA licensing now face an urgent need to refile under CDSCO. Excipient Re-Screening Effort Companies must re-examine excipients across their entire portfolio for Indian novelty status, even where global approval already exists. Business Opportunities Created 1. CDSCO Dual-Application Filing Services (Core Opportunity for Corpseed) Service Target Clients CDSCO New Drug permission for SR/ER/PR/DR formulations and bulk intermediates Formulation manufacturers and CDMOs Coordinated dual-dossier drafting (finished formulation + intermediate) Formulators working with external pellet/granule CDMOs Excipient novelty screening and safety dossier preparation R&D teams and ingredient importers SLA license filing and renewal for standard granules DC granule and taste-masked granule manufacturers Import documentation and CDSCO port office liaison Importers of formulation intermediates Annual compliance monitoring and SKU re-classification All manufacturers holding mixed CDSCO/SLA portfolios 2. SKU Classification and Portfolio Audit Services Reviewing every formulation intermediate SKU against the CDSCO/SLA matrix Identifying SKUs currently under SLA licenses that should be reclassified to the CDSCO track Corpseed can manage the full classification process for clients, including: Reviewing release-mechanism data for each product Screening excipients against Indian regulatory precedent Flagging high-risk SKUs requiring urgent CDSCO filing 3. Inspection Readiness Audits for CMOs and Formulators CMOs and formulators face show cause notices and batch seizures in case the intermediate licensing does not coincide with the present CDSCO categorization. Corpseed will audit intermediate licensing for: CDSCO authorization for SR/ER/PR/DR pellets & granules SLA authorization for standard DC and taste-masked granules Apply for approval from CDSCO/SLA prior to the next audit cycle 4. Technical and Regulatory Advisory for Smaller CDMOs Not all smaller pellet and granule makers can afford to have an in-house regulatory team. What they need is affordable and targeted assistance for: Evaluating if their current SKUs qualify for the CDSCO or the SLA path Preparing the comprehensive application data package Answering any queries that may arise from CDSCO or SLA during the dossier review Corpseed can provide such assistance through defined advisory packages 5. M&A and Investment Due Diligence Support Pharma companies undergoing fundraising, acquisition, or licensing-out transactions need a clean intermediate licensing record. Corpseed can: Compile a classification report covering every formulation intermediate in the target company's portfolio Identify and quantify any CDSCO/SLA misclassification risk ahead of due diligence Support remediation before disclosure to counterparties Corpseed's Core Message for This Service Given Corpseed's existing work in pharmaceutical regulatory compliance, CDSCO's 2026 formulation intermediate clarification is a direct, time-sensitive opportunity. Because the circular operates as an immediate enforcement baseline rather than a future-dated rule, manufacturers and CDMOs holding SLA-only licenses for SR/ER/PR/DR intermediates are already exposed, with no formal grace period to fall back on. This urgency, combined with a clear and well-defined service scope, makes CDSCO/SLA dual-track compliance a high-demand service for Corpseed.

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Summary: The Government of India has introduced a new Risk Classification Module on the CDSCO Online System for Medical Devices. This update simplifies the approval process and makes it easier to classify medical devices that are not listed in the CDSCO published classification list. The module became active on 27 November 2025 under the Medical Device Rules, 2017. Any applicant can now submit device details through the CDSCO medical device portal to get the correct risk category for the product. This new system supports faster regulatory review, improves compliance, and helps ensure the safe use of medical devices across the country. The change also supports better transparency and smoother processing of applications for medical device risk classification.

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Summary: The Central Drugs Standard Control Organization (CDSCO) has officially finalized the risk classification of medical devices used in interventional radiology and radiotherapy under the Medical Devices Rules, 2017. These classifications comply with the draft lists released on January 6, 2025. The updated lists are included in Appendix A of the respective notifications and give a structured framework for defining regulatory requirements for manufacturing and import. The CDSCO elucidates that the general intended use given for each device acts only as guidance, manufacturers may describe particular intended uses for their products. The notified classifications are active and may be revised from time to time under the Medical Devices Rules, 2017. Each device is assigned to Class A, B, C, or D, which determines the applicable regulatory pathway to ensure safety, quality, and compliance for technologies used in radiological and therapeutic procedures.

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Summary: The Ministry of Health and Family Welfare on Tuesday notified draft amendment rules for the registration of Class A medical devices through an identified online portal established for the purpose. All the A and B-class manufacturers are required to transition to the licensing regime by 1st October. This notification came as a big relief to the manufacturers who are still awaiting audits from the government licensing authorities. The Key highlights of the draft amendment rules for Manufacturer The manufacturer has to only submit an undertaking stating that the proposed device is Class A Medical Device (non-sterile and/or non-measuring) The manufacturer shall self-certify that the product is conforming to the essential principles’ checklist of safety and performance of such devices. The manufacturer shall self-certify to comply with the standards prescribed in the Medical Devices Rules, 2017.