Obtaining a manufacturing licence from the Central Drugs Standard Control Organization (CDSCO) or the applicable State Licensing Authority is an important milestone for a medical device manufacturer in India. However, obtaining the licence is only the beginning of the manufacturer's regulatory responsibilities.
Medical device manufacturers must continue to comply with applicable licensing conditions, quality management system (QMS) requirements, documentation controls, product safety obligations, and post-market surveillance requirements throughout the product lifecycle.
Under the Medical Devices Rules, 2017 (MDR 2017), manufacturing licences issued in Forms MD-5, MD-6, MD-9, and MD-10 remain valid in perpetuity, subject to the applicable licence retention fee requirements and unless the licence is suspended, cancelled, or otherwise ceases to be valid under the Rules. Rule 29 establishes the five-year retention-fee requirement and specifies consequences for delayed payment.
For manufacturers, licence retention should therefore be treated as part of an ongoing regulatory compliance programme rather than as an isolated administrative task.
This guide explains the key considerations for CDSCO manufacturing licence retention, documentation management, quality system maintenance, and post-approval regulatory compliance.
Licence retention refers to fulfilling the applicable regulatory and fee requirements necessary to maintain the continuing validity of an existing manufacturing licence.
The relevant licence forms under the Medical Devices Rules, 2017, include:
The applicable licensing authority and regulatory pathway depend on the device classification and the provisions governing the particular application.
Manufacturers should maintain a centralised record of their licences, approved devices, manufacturing locations, and applicable retention deadlines.
Important: Continuous validity does not mean that a licence is exempt from regulatory obligations. The licence remains subject to the applicable Rules, licence conditions, and the authority's powers to suspend or cancel it.
Rule 29(1) of the Medical Devices Rules, 2017, provides that the licence retention fee specified in the Second Schedule must be paid before completion of five years from the date of issue of the licence.
Manufacturers should calculate the due date from the actual licence issue date and schedule the required payment sufficiently in advance.
Rule 29(2) also addresses late payment. Where the prescribed retention fee is not paid by the due date, the licensee is liable for the applicable late fee. The Rule specifies a rate of 2% of the licence retention fee for every month or part thereof, subject to the prescribed 180-day period. If the required fee is not paid within that period, the licence is deemed to have been cancelled under the Rule.
Manufacturers should not rely on a late-payment period as an extension of the original deadline.
A regulatory tracker should contain the following information:
Maintaining this tracker can help reduce the risk of missed deadlines and incomplete records.
A manufacturing licence may cover devices approved at the time of grant and devices subsequently authorised through the applicable regulatory process.
Manufacturers should maintain an up-to-date record of the products covered by each licence, including:
Before submitting a retention-related application or completing a compliance review, the manufacturer should reconcile its internal product list with the current licence and available regulatory records.
Additional devices must be handled through the applicable approval or permission process. A retention-fee payment should not be treated as authorisation to manufacture an additional device or implement an unapproved change.
Where a CDSCO circular, FAQ, or subsequent clarification establishes a specific procedure for endorsements, that procedure should be verified against the current official publication before it is applied.
The exact documents and submission procedure depend on the licence, the applicable authority, and current regulatory instructions. Manufacturers should verify the latest official checklist before preparing a submission.
Review the following, as applicable:
Confirm that the relevant technical records remain current and consistent with the approved product:
The manufacturer should also review records demonstrating continued compliance with applicable licence conditions and quality system requirements:
These records form part of ongoing compliance management. Their inclusion in an internal retention-readiness review does not mean that every item is necessarily a mandatory attachment to every retention-fee submission.
A valid manufacturing licence must be supported by continued compliance with the applicable requirements of the Medical Devices Rules, 2017.
The Fifth Schedule specifies quality management system requirements for medical device manufacturing. Manufacturers should ensure that their actual operations remain consistent with the approved processes and applicable regulatory obligations.
Key areas to monitor include:
Document control: Ensure procedures, work instructions, specifications, and quality records are appropriately approved and maintained.
Production controls: Verify that manufacturing activities follow established procedures and that required process controls and validation activities are maintained.
Supplier management: Evaluate suppliers and outsourced processes according to their impact on product quality and regulatory compliance.
Equipment and infrastructure: Maintain appropriate equipment qualification, calibration, maintenance, and environmental controls.
Personnel competence: Ensure that required technical personnel remain appropriately qualified and that training records are current.
Internal audits: Conduct audits according to the established quality system and address identified non-conformities.
Corrective and preventive action: Investigate problems, identify their causes, implement appropriate actions, and evaluate effectiveness.
Traceability and records: Maintain the manufacturing, testing, distribution, and other records required by applicable rules and procedures.
Complaint handling: Investigate complaints, assess potential safety concerns, and document decisions and actions.
A documented QMS review helps the manufacturer identify compliance gaps before they develop into more serious regulatory or product-quality issues.
The Device Master File and Plant Master File are important elements of medical device regulatory documentation, where applicable to the product and licensing pathway.
The DMF generally contains device-specific information, while the PMF describes relevant manufacturing-site and facility information.
Manufacturers should review these documents when changes occur and ensure that the content remains aligned with actual operations and the applicable approved regulatory position.
Review changes relating to:
Review changes relating to:
A change should be assessed through the manufacturer's change-control system to determine whether documentation updates, notification, prior approval, inspection, or a fresh licence is required.
Updating an internal file alone does not replace a regulatory submission or approval where one is required.
Changes made after a licence is granted must be assessed against the applicable requirements of the Medical Devices Rules, 2017, including Rule 26, Rule 27, and the Sixth Schedule, where relevant.
Manufacturers should not assume that all changes can be implemented solely through an internal procedure.
Examples of changes that may require regulatory assessment include:
The regulatory pathway depends on the nature of the change and the applicable provisions.
A proposed change in manufacturing location requires particular attention. Manufacturers should verify the applicable licensing procedure and inspection or audit requirements before implementing the change.
The existing licence should not automatically be assumed to cover a new manufacturing site. The required application, assessment, inspection, or fresh licence should be determined from the current official requirements.
Rule 27 establishes specific obligations where the constitution of a licensee changes. These include notifying the relevant licensing authority within the prescribed period and applying for a licence in accordance with the Rule.
Manufacturers should assess such changes promptly rather than waiting until the next licence retention deadline.
Where a manufacturer intends to add devices to an existing licensed site, the applicable permission or licence process must be followed. Rule 25(3) addresses applications for permission to manufacture additional devices for the Class C and Class D licensing pathway; the applicable provisions for other classes should also be checked.
Best practice: Record each proposed change, assess its regulatory significance, document the decision, and obtain any required approval before implementation.
Regulatory compliance continues after a medical device has entered the market.
Manufacturers should maintain appropriate systems for monitoring product performance, identifying safety concerns, investigating complaints, and implementing necessary corrective actions.
Depending on the device and applicable requirements, these activities may include:
Rule 26 includes conditions relating to the reporting of certain suspected unexpected serious adverse events and actions taken, including recalls. Manufacturers should verify the applicable reporting triggers, timelines, and current reporting instructions before handling a reportable event.
Post-market information should feed into the quality management system and risk management process. Repeated complaints, unexpected failures, or safety signals should be evaluated and documented appropriately.
Before completing the retention-fee process, manufacturers can use the following internal readiness checklist.
This checklist is an internal planning aid and should be adapted to the manufacturer's licence, device portfolio, and current regulatory requirements.
Medical device manufacturers can reduce regulatory risk by avoiding these common compliance gaps:
Waiting until the last minute: Delaying fee verification or payment can create avoidable risks, particularly where an application or payment process requires additional time.
Assuming perpetual validity means no further obligations: Licence retention does not remove the manufacturer's ongoing responsibilities under the Rules.
Maintaining outdated product records: Internal device lists should be reconciled with applicable licences, permissions, and endorsements.
Implementing changes without regulatory assessment: A seemingly administrative change may have implications for the licence or approved manufacturing arrangements.
Treating the checklist as a universal submission list: Required documents can vary according to the licence and applicable official instructions.
Neglecting post-market records: Complaints, reportable safety events, and corrective actions must be handled through the applicable systems and timelines.
Relying on outdated guidance: Regulatory requirements and official procedures may change. Always check the latest applicable notification, circular, clarification, and rule.
CDSCO manufacturing licence retention is an important part of maintaining the regulatory status of a medical device manufacturing business in India. Manufacturers holding licences in Forms MD-5, MD-6, MD-9, or MD-10 should monitor the five-year retention-fee deadline while continuing to fulfil the applicable licensing conditions and quality system requirements.
A structured compliance programme should cover licence tracking, fee management, product endorsements, DMF and PMF maintenance, change control, QMS effectiveness, and post-market safety activities.
The key is to maintain ongoing compliance rather than treating retention as a one-time administrative exercise. Before making a submission or implementing a change, manufacturers should confirm the current applicable requirements through official CDSCO publications and the relevant State Licensing Authority, where applicable.
MDR Consultants supports medical device manufacturers with CDSCO licensing, licence retention planning, post-approval regulatory changes, DMF and PMF documentation, QMS support, and regulatory compliance.
Contact MDR Consultants to discuss your licence status, upcoming retention deadline, and regulatory documentation requirements.
Last Updated : 16 Oct 2026
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