The landscape for medical devices in India has undergone a paradigm shift since 2020 with increasing government regulation on multiple levels. In the past, the majority of medical devices were regulated at the local/regional level. However, beginning April 1, 2020, the scope and definition of what medical devices constitute increased greatly leading to the majority of medically related products becoming regulated. As a result, manufacturers and importers will now be required to implement Internationally Accepted Quality Management Systems and an ISO 13485:2016 Medical Device Certificate will become a key component of meeting compliance requirements for medical device registration and licensing. This article describes the specific categories of medical devices that have now become subject to federal regulation starting in 2020 as well as how ISO 13485 will integrate into the medical device registration and licensing process. Additionally, this article will provide information on how to obtain an ISO 13485:2016 Certification Service in India, as well as guidance for manufacturers and Importers regarding current Market-Readiness Requirements.
What is ISO 13485:2016 and why is it important for India?
The International Organization for Standardization (ISO) released the ISO 13485:2016 standard which provides an international standard for quality management systems of medical devices. This standard expresses the requirements of a quality management system (QMS) at a high level and defines the minimum requirements for processes, documentation, risk management, supplier control, traceability, post-market surveillance and regulatory alignment throughout the product life cycle (planning through to decommissioning). When purchased/regulated by regulators or purchasers, ISO 13485:2016 Certification indicates that a company has established systematic controls associated with designing, manufacturing and servicing medical devices. ISO 13485 serves as an international benchmark for industry and regulators globally for a quality management system for medical products that are intended to be used in clinical settings.
According to the guidance from CDSCO and its registration checklist, many device categories require or place a significant influence on the registration review process upon receipt of a certificate or declaration of conformance to ISO 13485. This indicates that the ISO 13485 Certificate Service is a key component of any market entry strategy into India.
The two waves: Notified devices, then the wider “newly notified” lists
To clarify which devices are required to demonstrate ISO 13485 compliant, the following two phases should be separated:
1. Notified Devices (previous list, small subset): Initially India had a list of notified devices (previously referred to in the communications as 37 categories). The notified devices are usually regarded as being higher-risk, more commonly associated with medical/surgical implants, dialysis equipment, pacemakers, some surgical consumables, and advanced imaging devices, and all these types of devices were already being monitored by CDSCO. As such, the documents needed for registering and/or importing/manufacturing devices in these categories required greater amounts of documentation and QMS documentation than normal.
2. Newly Notified / All Devices (from 2020): The 2020 amendment broadened the scope of notification by including many more types of devices. Subsequently, CDSCO issued draft and issued final classifications for large numbers of additional newly notified devices (approximately 1,000 individual device classifications in total) and required the registration and/or licensing of all devices using an online portal. In instances where registration or licensing is required, CDSCO has also requested proof of ISO 13485 compliance (or a commitment/timeline to achieve this compliance). Transition relief measures have been implemented from time to time.
The net: since 2020 (and refined in subsequent amendment rules and guidance), most devices that require registration / import or manufacture licensing are expected to have ISO 13485 compliance documented during the submission process especially Class B, C and D devices and many of the newly notified categories
Which device categories were newly affected (overview)?
CDSCO has made some changes that will broadly regulate all forms of medical devices on a risk-based basis. The new regulations have added more requirements for many types of devices from clinical segments listed below to hold stronger expectations of QMS after 2020. Particularly with respect to medium to high-risk devices:
ISO 13485:2016, for the most part, has become a requirement at the time of registration or for licensing many devices in these categories. For many devices in these categories ISO 13485: 2016 has become a de facto requirement upon registration or licensing of the device either as a standard CDSCO would have expected on all submission of the Conformity Assessment but would have also indicated to the registration/license applicant or on all submissions for the device through the notified body to CDSCO.
Why ISO 13485:2016 matters for these categories
1.Risk-based confidence: High-risk devices (Class C & D) directly affect patient safety; regulators prefer audited QMS evidence to ensure consistent design control, production and post-market vigilance.
2.Global harmonization: ISO 13485:2016 aligns Indian manufacturers with international best-practices simplifying export compliance and acceptance by foreign regulators or procurers.
3.Regulatory expectation: CDSCO’s guidance and application forms frequently ask for QMS evidence. For imported devices, authorities often request an audited ISO 13485 certificate for the site of manufacture as part of the dossier.
4.Supplier and procurement demand: Hospitals, government tenders and institutional buyers increasingly require suppliers to hold ISO 13485 certification especially when devices are used in critical care or invasive procedures.
5.Better internal controls: Implementing ISO 13485 helps companies formalize processes (design controls, risk management, CAPA, supplier control), which reduces product recalls and non-conformances.
Device class and ISO 13485 expectation: practical rule of thumb
India's risk-based classification system consists of four classifications (A-D); however, the risk-based approach utilized by India maps relatively well to ISO 13485 requirements and expectations.
• Class A devices (low risk) – A significant number of Class A devices were previously exempted from the full licensing requirements and were ultimately not required to be listed with the CDSCO until after the 2020 transition to a risk-based classification system. Because of this, the benefit of getting these devices licensed through the CDSCO has not been as substantial as it was for Class B and Class C devices because the majority of Class A devices were not necessarily commercialized; hence ISO 13485 cannot always be confirmed as being enforced as a "hard" law for Class A devices. Nonetheless, having an ISO 13485:2016 Medical Device Certificate is often required or strongly recommended by purchasers as well as during the export process.
• Class B devices (Low-Mid Risk) – Most Class B devices must be registered or licensed by the CDSCO; therefore, CDSCO expects the use of a QMS. As such, to register a Class B device, the ISO 13485:2016 Certificate and all associated documentation will need to be included as part of the registration dossier.
• Class C and D devices (Moderate-High/High Risk) – For Class C and D devices, compliance with ISO 13485 is essentially mandatory for the registration process and for the importation and manufacturing phases of the device. For the majority of the higher-risk devices being presented for registration with the CDSCO, the CDSCO will request proof of compliance with ISO 13485 (from NABCB/IAF or other accredited third-party certification body).
The ISO 13485 standard will always provide great value; it becomes a regulatory "must-have" for devices that are classified as mid-level or higher risk. Additionally, many newly notified categories where registration is mandatory will also require ISO 13485 compliance.
How ISO 13485:2016 became central to compliance in India
ISO 13485 is the globally accepted benchmark for QMS for Medical Devices. In India, the regulators do not require sole certification as evidence of compliance under all scenarios; however, since the amendments in 2020, it has been specified in the subsequent guidance that it is mandatory for manufacturers to comply with QMS as part of their registration and licensing process for a Device to be registered and sold in India. A certified ISO 13485:2016 or an acceptable demonstration of compliance with the ISO 13485 requirements is one of the most widely recognized forms to provide evidence of compliance with international standards for a manufacturer’s QMS. For some pathways to gain approval, submission of an ISO 13485 Certification or providing evidence demonstrating that the QMS is aligned to ISO 13485 will expedite the approval significantly.
What to take from this:
• Importers typically need a Free Sale Certificate from the country of origin as well as an ISO 13485 QMS evidence from the manufacturer.
• For Domestic Manufacturers, having a Certified ISO 13485:2016 Certificate Service in India shows that the manufacturer has an established and compliant QMS, which leads to fewer requests and a simplified process for CDSCO inspections.
What does “ISO 13485:2016 Certificate” mean practically for a manufacturer?
An ISO 13485:2016 Certification is issued by a third-party certification organization when they perform an assessment of the manufacturer's Quality Management System to see if it meets all of the requirements found in ISO 13485:2016. The following represent what happens as part of that process:
1.) Documented Quality Management System - The procedures used by the manufacturer must be documented and contain documentation regarding all areas of design control, production, traceability, supplier control, corrective actions, and dissemination of out-of-specification product information. ISO13485 requires manufacturers to document and repeat their processes based upon the risk associated with the medical device they produce.
2.) Audit and evidence - A certification organization performs an audit for the manufacturer; this audit could be a one-time certification audit and the renewal audits will occur yearly. These audits and related documentation provide the endorsement required by regulatory authorities (i.e. CDSCO) or foreign regulatory authorities.
3.) Integration of regulatory submissions - When the application for registration or a license of the medical device is submitted for review, the technical files, clinical data as needed, and Quality Management System evidence is submitted, and these documents will be reviewed together. ISO 13485 allows you to meet and exceed the expectations of many different regulatory bodies and reduces the amount of back and forth.
How to obtain an ISO 13485:2016 Certificate Service in India — step-by-step (practical guide)
If your device is now classified under a central authority's regulation, and you must provide ISO 13485 evidence, here is a realistic route to compliance:
1: Perform Gap Analysis/Scoping
Determine what areas of ISO 13485 are applicable (the four main areas are design, manufacture, sterilization & support). If you are a contract manufacturer or a supplier of components, the scope may be reduced. Perform a gap analysis to determine your current gap(s) against ISO 13485:2016.
2: Develop the Quality Management System (QMS)
Develop a Quality Manual and create documented procedures (SOP’s) for production, supplier control, Management Review, CAPA, Risk Management (ISO 14971) and Post-Market Regulatory Planning (these documents are generally also included in your submission to the CDSCO).
3: Execute and Operate the QMS
Train personnel and conduct a pilot production run with applicable controlled documents to capture nonconformities, CAPAs and improvement cycles. Auditors conducting certification audits will want to see evidence that there is active implementation of the QMS and not just the document.
4. Select an accredited Certification Body (CB)
Use an accredited Certification Body, such as NABCB in India or other International CBs approved by a recognized accreditation agency. Ensure that their accreditation is applicable to the medical device manufacturer and associated technologies you are applying to.
5. perform the certification audit
Certification Audits consist of Stage 1 (Initial documentation audit) and Stage 2 (Implementation audit). Review non-conformities and obtain ISO 13485 certification along with On-going Surveillance audits.
6. Incorporate Certificate into CDSCO registration/license
Upload ISO 13485 Certification and QMS documentation onto the CDSCO Medical Devices Online Portal, when requesting Registration and/or a Manufacturing/Import License. Maintain up to date copies of certificates and on-going Surveillance Audits.
Action checklist for manufacturers & importers (quick, practical)
1.Map your product to CDSCO classification (A–D) and check whether it was part of the previously notified list or included after April 2020.
2.Conduct ISO 13485 gap analysis immediately if you don’t have a QMS aligned to ISO 13485:2016.
3.Prepare device technical file (design, performance, safety data) alongside your QMS — regulatory reviewers will evaluate them together.
4.Choose an accredited certification body experienced with medical devices and NASCB/NABL recognition where relevant.
5.Plan for post-market systems (complaint handling, vigilance, device tracking) — CDSCO expects this as a part of QMS
Common business benefits of getting ISO 13485 beyond compliance
1.Market Access – Your filing process is streamlined for all of the countries where you will sell your devices and meets the expectations of your distributors/importers.
2. Operational Consistency - By controlling your suppliers more completely, your products will have fewer defects, be manufactured consistently, and have a predictable supply chain.
3. Brand Trust - Clinicians, hospitals, and purchasing departments prefer to buy devices that have been manufactured in compliance with a certified Quality Management System (QMS).
Common challenges and how to address them
1.Completeness of Design Dossier: Many audits fail due to a lack of completeness regarding design inputs (e.g., design specifications), risk analyses, verification/validation records, and change control. Solutions: Create a Design History File (DHF) template and enforce the discipline of change control.
2.Control of Suppliers: Auditors also want to see how the company controls suppliers, including supplier selection, qualification and periodic evaluation. Solutions: Maintain a supplier list (a minimum of two suppliers), perform supplier audits, or document supplier evaluations and periodically review supplier performance metrics.
3.Sterilization and Biocompatibility Evidence: The validation of the sterilization process and biocompatibility of products that are found to be sterile and/or implantable is crucial. Solutions: Identify accredited testing laboratories to evaluate sterilization processes and include copies of the sterilization validation reports in the design dossier.
4.Post-Market Data: Complaint handling, trend analysis, vigilance reporting, etc., must be established and functioning post-market. Solutions: Establish a simple workflow for handling complaints and prepare monthly trend analyses.
5.Selecting the Right Certification Body: All certifying bodies are not created equal in terms of medical device experience. Solutions: Choose a certification body that is a member of the International Accreditation Forum (IAF) or a member of the National Association of Business Certification Bodies (NABCB) with experience in the medical device sector.
Common pitfalls and how to avoid them
1)Treating ISO as a Paperwork Exercise
ISO 13485 requires the integration of ISO 13485 standards in an organization's operations daily; if the documentation developed is superficial, the organization will fail during a site visit.
2) Ignoring Design Control Symptoms
Medical device manufacturers must focus on the principles of design validation, design verification, and design traceability during the product development process.\
3) Underestimating Supplier Control
Most non-conformance reports can be attributed to inadequate incoming inspection, unclear supplier expectations and requirements, or lack of supplier audits.
4) One Size Fits All
At an organization level, proper scoping of an ISO certification and its respective processes and products will minimize unnecessary rework due to incorrect assumption of ISO certification scope.
5) Delaying Post-Market Vigilance
ISO requires organizations to have processes in place for designing, developing, and supplying their products within confirmed timelines; the use of post-market surveillance to monitor existing products.
Conclusion
India has advanced in its evolution of regulatory framework and the evolution of its medical devices industry, transitioning from an evolving regulatory framework to a predictable, risk-based system for the medical devices industry. One development that has been a key component of this evolution is the increased significance that ISO 13485:2016 represents to Indian medical device manufacturers and importers today. While ISO 13485 is not a requirement for all medical devices in India, it has become an indispensable element of evidence for medium- and higher-risk devices, especially the Class C and D devices, when companies seek to register, import or procure their devices within India. Therefore, it is highly recommended for manufacturers and importers of medical devices in the Anesthesia, Cardiovascular, Orthopedic, High-End Imaging, High-Risk IVD, and Critical Medical Device categories to implement an ISO-aligned Quality Management System, obtain an ISO 13485:2016 Medical Device Certificate through an accredited certification body in India and establish working relationships with reputable ISO 13485:2016 Certificate Services in India in order to facilitate the regulatory processes required for introduction into the Indian marketplace.
Frequently asked questions (FAQ)
Q1 Can an overseas manufacturer use an overseas ISO 13485 certificate for CDSCO registration? A: Yes — CDSCO recognizes certificates from accredited certification bodies. Importers commonly submit the manufacturer’s ISO 13485 certificate plus a Free Sale Certificate or market authorization from the country of origin. The Indian authorized agent/importer must ensure documents meet CDSCO’s checklist.
Q2: Which device classes most commonly need an ISO 13485 certificate? A: Class C and Class D devices (higher-risk and implantable devices) most commonly need explicit ISO 13485 evidence. Notified devices (historical 37 categories) also are subject to strict QMS expectations.
Q3: How long does it take to get ISO 13485:2016 certification? A: Implementation time depends on starting maturity. A simple gap-remediation and documentation exercise could be a few months; full implementation and passing an audit typically takes several months to a year depending on size and readiness. (Plan for stage-1 and stage-2 audits and surveillance cycles.)
Q4: Can small manufacturers rely on consultants to get the ISO 13485:2016 Medical Device Certificate? A: Yes — experienced consultants help build documentation, processes and evidence. However, the manufacturer must operate the QMS; consultancies can’t replace real implementation or produce fraudulent evidence. Certification bodies audit actual implementation.
Q5: Does ISO 13485:2016 guarantee market approval in India? A: No. ISO 13485 helps meet QMS expectations and usually smooths regulatory review, but device-specific technical dossiers, clinical evaluation, labeling and other statutory requirements must also be satisfied for registration and licensing.
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