Permission to Manufacture Investigational
Medical Devices
(Form
MD-27)
Form MD-27 is a permission granted by the Central Drugs Standard Control Organization under the Medical Devices Rules 2017 (Rule 62), allowing manufacturers to produce investigational medical devices. It is issued by the Central Licensing Authority specifically for devices that are not yet approved, but required for clinical investigation and performance evaluation. The manufacturing is strictly limited to trial-specific quantities and these devices cannot be sold or commercially distributed. Unlike licenses such as MD-5 or MD-9, which permit commercial manufacturing, MD-27 is exclusively for research and clinical study purposes. It acts as a critical regulatory pathway enabling legal production of investigational devices under CDSCO oversight.
When Do You Need MD-23 Support
and What Are the Key Challenges?
Support for investigational medical devices requiring clinical evidence generation, controlled manufacturing, and regulatory approval under the Medical Devices Rules, 2017.
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When manufacturing investigational medical devices for clinical investigation or performance evaluation
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After obtaining clinical investigation approval under Form MD-23, where applicable
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For new or innovative devices requiring clinical evidence generation
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When significant design, material, or intended-use changes require additional investigation
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For limited-quantity manufacturing intended only for investigational or non-commercial use
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To generate regulatory data before applying for commercial manufacturing Licenses such as MD-5 or MD-9
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Extensive documentation requirements
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Dependency on MD-23 approval
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Strict quality & GMP compliance
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Regulatory queries and approval delays from Central Drugs Standard Control Organization
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Controlled manufacturing restrictions
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Labelling and usage compliance under Medical Devices Rules 2017
Our Approach and What You Will Get
End-to-end support for Medical Devices Rules, 2017 compliance, clinical investigation alignment, documentation, and CDSCO approval processing.
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Regulatory pathway assessment as per Medical Devices Rules 2017
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Strategic alignment with clinical investigation (MD-23)
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End-to-end documentation preparation (DMF, QMS, labelling)
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Gap analysis and compliance review
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Coordination with Central Drugs Standard Control Organization
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Query management and response handling
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Support till approval and post-approval compliance
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Full regulatory support as per Medical Devices Rules 2017
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Accurate, compliant documents (DMF, QMS, labelling)
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Smooth coordination with CDSCO
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Faster approvals with smart execution
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Expert handling of any regulatory questions
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Risk-free, compliant MD-27 manufacturing permission
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Complete guidance from application to approval and beyond
Why Choose Tacit Medtek and Case Example
Reliable support for investigational device manufacturing approval, aligned with clinical investigation requirements under CDSCO.
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Deep understanding of CDSCO rules under Medical Devices Rules, 2017
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Smooth, compliant support for regulatory approvals
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End-to-end support—from strategy to final approval
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Assistance with document prep, submission, and coordination
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Results-driven approach for efficient regulatory execution
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Faster approvals through smart planning and consistent follow-ups
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Accurate, compliant, error-free documentation
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Fewer delays with proactive regulatory management
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Dedicated client support and timely communication
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A reliable long-term regulatory partner for continuous compliance across the product lifecycle
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Challenge: A growing medical device company was preparing for a multi-centre clinical investigation in India but did not have approval to manufacture investigational devices locally. They were unsure about regulatory expectations, documentation requirements, and how to align manufacturing with clinical study approvals under CDSCO.
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Our Approach: Assessed the clinical investigation scope and aligned it with MD-27 requirements. Confirmed the connection between MD-23 approval and manufacturing permission. Reviewed the manufacturing facility for ISO 13485 compliance and investigational device controls. Prepared a complete MD-27 application—specifications, risk management file, and study docs. Ensured compliant labelling ("For Clinical Investigation Use Only") and traceability. Managed CDSCO submission and answered technical queries smoothly.
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Outcome: The client received MD-27 approval within 40–50 days, enabling timely manufacturing of investigational devices and seamless initiation of their clinical study in India.
FAQ
Frequently Asked Questions
Generally, investigational medical devices approved exclusively for export purposes are not considered equivalent predicate devices for regulatory submissions in India.
Once an Investigational medical device is approved by the Central Licensing Authority and the product is already marketed in the country, then same can be considered as a predicate device & subsequent applicant may obtain license after complying with the requirements of MDR-2017.
The applicant shall submit an application in Form MD-26 to obtain the permission in Form MD-27 under MDR-2017.
The applicant is required to submit documents as per Part IV of Fourth Schedule of Medical Devices Rules, 2017.
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