MD-15 Import Licence (India): Complete document checklist

MD-15 Import Licence (India): Complete document checklist. In India, an MD-15 licence is the legal authorisation issued by CDSCO to import and place medical devices on the market. You apply through Form MD-14 on the SUGAM/NSWS portal; upon approval, CDSCO grants the licence in Form MD-15. The content and format of submissions draw heavily from the Fourth Schedule of MDR 2017 (including Appendix I – Plant/Site Master File and Appendix II – Device Master File), and CDSCO’s own checklists for MD-14/MD-15.
Covering and authority documents

Covering Letter: A formal cover note referencing the applicant, site(s), device families, classes, and the exact scope (fresh licence or endorsement). It helps CDSCO route the file correctly and cross-check the fee challan and forms. CDSCO’s MD-15 checklist begins with this.

Application in Form MD-14 and fee challan: MD-14 is the application vehicle; MD-15 is the licence output. Ensure fee proof matches the device count and site(s) you’re seeking.

Power of Attorney (PoA) with Undertaking by the Authorised Agent (AA): This must follow Part I of the Fourth Schedule and be authenticated in India by a First-Class Magistrate/Indian Embassy or apostilled. The PoA establishes the AA’s legal standing to interact with CDSCO and assume liabilities

Authorised Agent’s regulatory capacity proof: Submit a copy of Wholesale/Manufacturing Licence or Registration Certificate in Form MD-42 (as applicable) plus constitution documents (MOA/AOA/LLP agreement/partnership deed, PAN, CIN, GST). These show the AA can legally import/wholesale in India.

Market authorisations and site approvals from the country of origin

Free Sale Certificate (FSC)/Marketing Authorisation from the Country of Origin (if available) – notarised: Confirms lawful marketing in the home jurisdiction; strengthens safety/performance assurance.

FSC/Marketing Authorisation from one of USA/UK/EU/Canada/Japan/Australia – notarised: Regulatory clearances from these reference markets are routinely requested by CDSCO to benchmark safety and performance.

Manufacturing site/plant registration issued by the competent authority in the country of origin – notarised: Demonstrates the site is recognised and overseen by a regulator.

Latest inspection/audit report (within the last 3 years, if any): Supports ongoing GMP/QMS compliance at the site.

Quality Management System and product conformity

Quality Management System certificate (e.g., ISO 13485) – notarised: Evidence that the manufacturer’s QMS conforms to internationally accepted standards.

Applicable Quality Assurance/CE certificates – notarised: CE or equivalent attestations help demonstrate conformity to essential safety/performance requirements.

Manufacturer’s Declaration of Conformity: A formal attestation that the device complies with applicable standards and regulatory requirements.

Technical documentation as per Fourth Schedule (core of the file) 
Under MDR 2017 Fourth Schedule, two anchor documents structure your technical evidence: the Plant/Site Master File (Appendix I) and the Device Master File (Appendix II for medical devices; Appendix III for IVDs). These govern the format for the items below.

Plant (Site) Master File (PMF/SMF): Covers site details, organisational structure, QMS, facilities, utilities, contamination controls, validations, and release systems. Use Appendix I format.

Executive Summary: High-level overview of the device, indications, classification, GMDN/UMDNS (if used), and regulatory status. Included within the DMF.

Device Description: Intended use, principles of operation, materials of construction, variants/accessories. DMF requirement per Appendix II.

Justification for Medical Device Grouping: Explains how models/variants form a single family for licence purposes important for correct fee calculation and licence scope.

Product Specifications, including variants and accessories: Detailed technical characteristics and performance ranges as per the DMF.

Substantial Equivalence: Comparison with a predicate device or previous versions to evidence comparable safety/performance where applicable.

Labelling Information (labels, IFU, packaging): Must reflect Indian labelling requirements; CDSCO checks alignment with intended use and contraindications.

Design and Manufacturing Information: High-level design controls, manufacturing flow, critical suppliers, and in-process controls as per DMF.

Essential Principles Checklist: A mapped justification showing how the device fulfils essential safety and performance principles explicitly referenced in CDSCO FAQs.

Risk Analysis and Control Summary: ISO 14971-aligned risk file summary, residual risk acceptability, and benefit–risk rationale.

Verification and Validation (V&V) Data: Bench testing, electrical safety/EMC, shelf-life packaging validation, performance testing traceable to standards.

Biocompatibility data (if applicable): Material characterisation and biological evaluation per ISO 10993 series, including endpoints relevant to patient contact.

Medicinal substance information (if applicable): If the device contains a medicinal component, provide pharmacological/toxicological data and regulatory status.

Biological safety on TSE/BSE (if applicable): Required where animal-derived materials are used.

Sterilisation validation (if applicable): Validation reports (e.g., EO, gamma, steam), SAL justification, and packaging sterility maintenance.

Software V&V (if applicable): Lifecycle documentation, architecture, cybersecurity considerations, and validation matched to software safety class.

Pre-clinical (animal) data (if any): Only where relevant to demonstrate performance/safety beyond bench data.

Stability studies – real-time & accelerated (if applicable): Supports shelf life and storage conditions for sterile/shelf-life limited products.

Clinical evidence (if any): Clinical evaluation or investigation reports as appropriate to the device risk class and intended use.

Post-marketing surveillance (PMS) / vigilance data: Complaint trends, adverse event summaries, CAPA demonstrates ongoing oversight.

Batch Release Certificates/Certificates of Analysis for at least 3 consecutive batches or software version release certificate (for software-only devices): Evidence of consistent quality/release controls for marketed units or controlled software builds.

“As-asked” documents

Any additional documents demanded by the licensing authority: CDSCO may raise queries (deficiency letters) asking for clarifications, test reports, or updated certifications respond on the portal within the stipulated time to avoid application lapses.

Practical tips to keep your MD-15 dossier “review-ready”

Follow the Fourth Schedule formats rigidly for PMF/DMF. It reduces back-and-forth and makes your file traceable to MDR 2017.

Synchronise device lists across MD-14, fee challan, PoA annexures, DMF model matrix, and labelling CDSCO looks for one-to-one alignment.

Notarisation/legalisation: where the checklist calls it out (PoA, FSC, site registration, QMS/CE), ensure notarised or apostilled copies as stated.

Keep inspections current: submit the latest site audit report (≤ 3 years old) where available; if not, explain what oversight applies

Expect queries: CDSCO FAQs confirm submission via SUGAM/NSWS and reference essential principles and PMF/DMF content tailor your responses to these anchors.

Primary references you can cite in your application notes

Medical Devices Rules, 2017: especially Fourth Schedule (Appendix I & II/III) for PMF/DMF structure.

CDSCO MD-14/MD-15 checklists: operative list of artefacts required for fresh and endorsement applications.

CDSCO FAQs (Medical Devices): clarifies PMF/DMF, essential principles, and portal submission.

Therefore, If you assemble the file exactly against the MD-15 checklist and structure your technical evidence per the Fourth Schedule, your review turns into a straightforward verification exercise for CDSCO: authority to act (PoA/AA), legal marketability (FSC/site approvals), site competence (QMS/inspections), and product conformity (PMF/DMF with V&V, risk, and labels). That combination is what ultimately converts an MD-14 application into an MD-15 import licence.
If you want, I can also reformat this into a Word file with your branding and insert a one-page checklist at the end for internal use.

In India, an MD-15 licence is the legal authorisation issued by CDSCO to import and place medical devices on the market. You apply through Form MD-14 on the SUGAM/NSWS portal; upon approval, CDSCO grants the licence in Form MD-15. The content and format of submissions draw heavily from the Fourth Schedule of MDR 2017 (including Appendix I – Plant/Site Master File and Appendix II – Device Master File), and CDSCO’s own checklists for MD-14/MD-15.

Covering and authority documents

Covering Letter: A formal cover note referencing the applicant, site(s), device families, classes, and the exact scope (fresh licence or endorsement). It helps CDSCO route the file correctly and cross-check the fee challan and forms. CDSCO’s MD-15 checklist begins with this.
Application in Form MD-14 and fee challan: MD-14 is the application vehicle; MD-15 is the licence output. Ensure fee proof matches the device count and site(s) you’re seeking.
Power of Attorney (PoA) with Undertaking by the Authorised Agent (AA): This must follow Part I of the Fourth Schedule and be authenticated in India by a First-Class Magistrate/Indian Embassy or apostilled. The PoA establishes the AA’s legal standing to interact with CDSCO and assume liabilities
Authorised Agent’s regulatory capacity proof: Submit a copy of Wholesale/Manufacturing Licence or Registration Certificate in Form MD-42 (as applicable) plus constitution documents (MOA/AOA/LLP agreement/partnership deed, PAN, CIN, GST). These show the AA can legally import/wholesale in India.

Market authorisations and site approvals from the country of origin

Free Sale Certificate (FSC)/Marketing Authorisation from the Country of Origin (if available) – notarised: Confirms lawful marketing in the home jurisdiction; strengthens safety/performance assurance.
FSC/Marketing Authorisation from one of USA/UK/EU/Canada/Japan/Australia – notarised: Regulatory clearances from these reference markets are routinely requested by CDSCO to benchmark safety and performance.
Manufacturing site/plant registration issued by the competent authority in the country of origin – notarised: Demonstrates the site is recognised and overseen by a regulator.
Latest inspection/audit report (within the last 3 years, if any): Supports ongoing GMP/QMS compliance at the site.

Quality Management System and product conformity

Quality Management System certificate (e.g., ISO 13485) – notarised: Evidence that the manufacturer’s QMS conforms to internationally accepted standards.
Applicable Quality Assurance/CE certificates – notarised: CE or equivalent attestations help demonstrate conformity to essential safety/performance requirements.
Manufacturer’s Declaration of Conformity: A formal attestation that the device complies with applicable standards and regulatory requirements.

Technical documentation as per Fourth Schedule (core of the file)

Under MDR 2017 Fourth Schedule, two anchor documents structure your technical evidence: the Plant/Site Master File (Appendix I) and the Device Master File (Appendix II for medical devices; Appendix III for IVDs). These govern the format for the items below.

Plant (Site) Master File (PMF/SMF): Covers site details, organisational structure, QMS, facilities, utilities, contamination controls, validations, and release systems. Use Appendix I format.
Executive Summary: High-level overview of the device, indications, classification, GMDN/UMDNS (if used), and regulatory status. Included within the DMF.
Device Description: Intended use, principles of operation, materials of construction, variants/accessories. DMF requirement per Appendix II.
Justification for Medical Device Grouping: Explains how models/variants form a single family for licence purposes important for correct fee calculation and licence scope.
Product Specifications, including variants and accessories: Detailed technical characteristics and performance ranges as per the DMF.
Substantial Equivalence: Comparison with a predicate device or previous versions to evidence comparable safety/performance where applicable.
Labelling Information (labels, IFU, packaging): Must reflect Indian labelling requirements; CDSCO checks alignment with intended use and contraindications.
Design and Manufacturing Information: High-level design controls, manufacturing flow, critical suppliers, and in-process controls as per DMF.
Essential Principles Checklist: A mapped justification showing how the device fulfils essential safety and performance principles explicitly referenced in CDSCO FAQs.
Risk Analysis and Control Summary: ISO 14971-aligned risk file summary, residual risk acceptability, and benefit–risk rationale.
Verification and Validation (V&V) Data: Bench testing, electrical safety/EMC, shelf-life packaging validation, performance testing traceable to standards.
Biocompatibility data (if applicable): Material characterisation and biological evaluation per ISO 10993 series, including endpoints relevant to patient contact.
Medicinal substance information (if applicable): If the device contains a medicinal component, provide pharmacological/toxicological data and regulatory status.
Biological safety on TSE/BSE (if applicable): Required where animal-derived materials are used.
Sterilisation validation (if applicable): Validation reports (e.g., EO, gamma, steam), SAL justification, and packaging sterility maintenance.
Software V&V (if applicable): Lifecycle documentation, architecture, cybersecurity considerations, and validation matched to software safety class.
Pre-clinical (animal) data (if any): Only where relevant to demonstrate performance/safety beyond bench data.
Stability studies – real-time & accelerated (if applicable): Supports shelf life and storage conditions for sterile/shelf-life limited products.
Clinical evidence (if any): Clinical evaluation or investigation reports as appropriate to the device risk class and intended use.
Post-marketing surveillance (PMS) / vigilance data: Complaint trends, adverse event summaries, CAPA demonstrates ongoing oversight.
Batch Release Certificates/Certificates of Analysis for at least 3 consecutive batches or software version release certificate (for software-only devices): Evidence of consistent quality/release controls for marketed units or controlled software builds.

“As-asked” documents

Any additional documents demanded by the licensing authority: CDSCO may raise queries (deficiency letters) asking for clarifications, test reports, or updated certifications respond on the portal within the stipulated time to avoid application lapses.

Practical tips to keep your MD-15 dossier “review-ready”

Follow the Fourth Schedule formats rigidly for PMF/DMF. It reduces back-and-forth and makes your file traceable to MDR 2017.
Synchronise device lists across MD-14, fee challan, PoA annexures, DMF model matrix, and labelling CDSCO looks for one-to-one alignment.
Notarisation/legalisation: where the checklist calls it out (PoA, FSC, site registration, QMS/CE), ensure notarised or apostilled copies as stated.
Keep inspections current: submit the latest site audit report (≤ 3 years old) where available; if not, explain what oversight applies
Expect queries: CDSCO FAQs confirm submission via SUGAM/NSWS and reference essential principles and PMF/DMF content tailor your responses to these anchors.

Primary references you can cite in your application notes

Medical Devices Rules, 2017: especially Fourth Schedule (Appendix I & II/III) for PMF/DMF structure.
CDSCO MD-14/MD-15 checklists: operative list of artefacts required for fresh and endorsement applications.
CDSCO FAQs (Medical Devices): clarifies PMF/DMF, essential principles, and portal submission.

If you want, I can also reformat this into a Word file with your branding and insert a one-page checklist at the end for internal use.