Satori One Click Solutions LLP

22/10/2026

𝗖𝗗𝗦𝗖𝗢 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝗟𝗶𝗰𝗲𝗻𝗰𝗲 𝗳𝗼𝗿 𝗖𝗹𝗮𝘀𝘀 𝗖 & 𝗗 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 – 𝗙𝗼𝗿𝗺 𝗠𝗗-𝟳 𝗖𝗵𝗲𝗰𝗸𝗹𝗶𝘀𝘁
A ready reference for manufacturers applying for a new licence under MDR, 2017.

𝗠𝗮𝗻𝗱𝗮𝘁𝗼𝗿𝘆 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀:
🔹 Covering Letter
🔹 Application (Form MD-7)
🔹 Fee Challan
🔹 Constitution of Firm (with supporting documents)
🔹 Establishment/Site Ownership/Tenancy Agreement

𝗣𝗹𝗮𝗻𝘁 𝗠𝗮𝘀𝘁𝗲𝗿 𝗙𝗶𝗹𝗲 (𝗔𝗽𝗽𝗲𝗻𝗱𝗶𝘅 𝗜, 𝗙𝗼𝘂𝗿𝘁𝗵 𝗦𝗰𝗵𝗲𝗱𝘂𝗹𝗲) – 𝗔𝗹𝗹 𝗠𝗮𝗻𝗱𝗮𝘁𝗼𝗿𝘆:
🔹 General Information of Facility
🔹 Personnel – Organisation Chart
🔹 Personnel – Qualification, Experience & Responsibilities
🔹 Premises & Facilities
🔹 Plant Layout with Scale
🔹 List of Equipment & Instruments (manufacturing & testing)
🔹 Sanitation
🔹 Production
🔹 Quality Assurance
🔹 Storage
🔹 Documentation

𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗦𝘆𝘀𝘁𝗲𝗺 – 𝗔𝗹𝗹 𝗠𝗮𝗻𝗱𝗮𝘁𝗼𝗿𝘆:
🔹 Undertaking – Fifth Schedule compliance
🔹 Quality Manual
🔹 Control of Documents
🔹 Control of Records
🔹 Management Responsibility
🔹 Resource Management
🔹 Control of Production & Service Provision
🔹 Internal Audit System
🔹 Control of Non-Conforming Product
🔹 Corrective & Preventive Action (CAPA)
🔹 Environmental Requirements Table

𝗗𝗲𝘃𝗶𝗰𝗲 𝗠𝗮𝘀𝘁𝗲𝗿 𝗙𝗶𝗹𝗲
🔹 Executive Summary
🔹 Descriptive Information
🔹 Grouping Justification
🔹 Product Specification (variants, accessories)
🔹 Substantial Equivalence (predicate comparison)
🔹 Labelling Information
🔹 Design & Manufacturing Information
🔹 Essential Principles Checklist (EPC)
🔹 Risk Analysis & Control Summary
🔹 Verification & Validation
🔹 Biocompatibility Data
🔹 Medicinal Substances Data (if drug)
🔹 Biological Safety (TSE/BSE)
🔹 Sterilization Validation
🔹 Software V&V
🔹 Animal Studies (Preclinical)
🔹 Stability Data (real-time & accelerated)
🔹 Clinical Evidence
🔹 PMS Data (vigilance reporting)
🔹 Batch Release Certificates (min. 3 batches)

At Satori One Click Solutions LLP, we help with:
🔹 CDSCO Class C & D manufacturing licence applications (Form MD-7)
🔹 Plant Master File & Device Master File preparation
🔹 Essential Principles Checklist (EPC)
🔹 Risk management (ISO 14971)
🔹 Verification & validation documentation
🔹 Stability studies & clinical evidence
🔹 Batch release documentation
🔹 Test Licence & MD-27 applications
🔹 Indian Agent services

𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝘂𝘀:
📧 𝘀𝗮𝘁𝗼𝗿𝗶𝗼𝗰𝘀@𝗴𝗺𝗮𝗶𝗹.𝗰𝗼𝗺
📞 +𝟵𝟭 𝟵𝟴𝟮𝟵𝟬𝟵𝟴𝟬𝟳𝟳 / +𝟵𝟭 𝟵𝟮𝟭𝟲𝟱𝟵𝟴𝟬𝟳𝟳
🌐 𝘀𝗮𝘁𝗼𝗿𝗶𝗼𝗰𝘀.𝗰𝗼𝗺

20/10/2026

𝗖𝗗𝗦𝗖𝗢 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝗟𝗶𝗰𝗲𝗻𝗰𝗲 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 – 𝗙𝗼𝗿𝗺 𝗠𝗗-𝟯 𝗖𝗵𝗲𝗰𝗸𝗹𝗶𝘀𝘁
A ready reference for manufacturers applying for a new licence, endorsement, or retention under MDR, 2017.

𝗙𝗥𝗘𝗦𝗛 𝗔𝗣𝗣𝗟𝗜𝗖𝗔𝗧𝗜𝗢𝗡 – 𝗠𝗮𝗻𝗱𝗮𝘁𝗼𝗿𝘆:
✔️ Covering Letter
✔️ Constitution of the Firm
✔️ Establishment/Site Ownership/Tenancy Agreement
✔️ ISO 13485 QMS Certificate
✔️ Plant Master File – Part 1
✔️ Device Master File – Part 1
✔️ Performance Evaluation Report (IVDs only)
✔️ Test Licence (for QC data generation)
✔️ Undertaking – Fifth Schedule compliance
✔️ Fee Challan
✔️ Legal Form (MD-3)
𝗡𝗼𝘁𝗲: Class A devices – Appendix II not required; upload information as per Part II of Fourth Schedule

At Satori One Click Solutions LLP, we help with:
🔹 CDSCO Manufacturing Licence applications (Form MD-3)
🔹 Plant Master File & Device Master File preparation
🔹 ISO 13485 QMS implementation
🔹 Test Licence applications
🔹 Performance Evaluation Reports
🔹 Retention & endorsement applications
🔹 PMS & vigilance documentation
🔹 Indian Agent services

𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝘂𝘀:
📧 𝘀𝗮𝘁𝗼𝗿𝗶𝗼𝗰𝘀@𝗴𝗺𝗮𝗶𝗹.𝗰𝗼𝗺
📞 +𝟵𝟭 𝟵𝟴𝟮𝟵𝟬𝟵𝟴𝟬𝟳𝟳 / +𝟵𝟭 𝟵𝟮𝟭𝟲𝟱𝟵𝟴𝟬𝟳𝟳
🌐 𝘀𝗮𝘁𝗼𝗿𝗶𝗼𝗰𝘀.𝗰𝗼𝗺

18/10/2026

𝗖𝗗𝗦𝗖𝗢 𝗙𝗿𝗲𝘀𝗵 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝗟𝗶𝗰𝗲𝗻𝗰𝗲 𝗳𝗼𝗿 𝗜𝗩𝗗 – 𝗙𝗼𝗿𝗺 𝗠𝗗-𝟯 𝗖𝗵𝗲𝗰𝗸𝗹𝗶𝘀𝘁
A ready reference for IVD manufacturers applying for a new manufacturing licence under MDR, 2017 (Class A & B).
𝗠𝗮𝗻𝗱𝗮𝘁𝗼𝗿𝘆 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀:
🔹 Covering Letter
🔹 Constitution Details of Manufacturer (MoA, AoA, COI, LLP/Partnership registration)
🔹 Plant Master File – Part 1 (Plant Layout with scale)
🔹 Device Master File – Part 1 (Executive Summary, Description, Specification, Design & Manufacturing Info)
🔹 Essential Principles Checklist (EPC)
🔹 Undertaking – Fifth Schedule compliance
🔹 Labelling & Pack Size
🔹 Fee Challan
🔹 Legal Form (MD-3)
𝗢𝗽𝘁𝗶𝗼𝗻𝗮𝗹 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀:
🔹 Latest inspection/audit report (within 3 years)
🔹 ISO 13485 QMS certificate
🔹 NOC – Animal Husbandry (Veterinary IVD)
🔹 NOC – BARC (RIA Kits)
🔹 Test Licence copy
🔹 Wholesale/Manufacturing Licence copy
𝗖𝗹𝗮𝘀𝘀 𝗕 – 𝗥𝗲𝗰𝗼𝗺𝗺𝗲𝗻𝗱𝗲𝗱 (𝗢𝗽𝘁𝗶𝗼𝗻𝗮𝗹):
🔹 Specific evaluation report (sensitivity & specificity)
🔹 Batch test report – 3 consecutive batches
🔹 Performance Evaluation Report (CMDTL/MDTL)
🔹 Stability studies – shelf life (3 lots), in-use (1 lot), shipping (1 lot)
🔹 Product Insert
𝗖𝗹𝗮𝘀𝘀 𝗔 – 𝗥𝗲𝗰𝗼𝗺𝗺𝗲𝗻𝗱𝗲𝗱 (𝗢𝗽𝘁𝗶𝗼𝗻𝗮𝗹):
🔹 Analytical technology summary
🔹 Working principle for novel technology
At Satori One Click Solutions LLP, we help with:
🔹 IVD Fresh Manufacturing Licence (Form MD-3)
🔹 PMF & DMF preparation
🔹 EPC & risk management (ISO 14971)
🔹 Stability studies & PER
🔹 PMS & vigilance
🔹 Indian Agent services
𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝘂𝘀:
📧 𝘀𝗮𝘁𝗼𝗿𝗶𝗼𝗰𝘀@𝗴𝗺𝗮𝗶𝗹.𝗰𝗼𝗺
📞 +𝟵𝟭 𝟵𝟴𝟮𝟵𝟬𝟵𝟴𝟬𝟳𝟳 / +𝟵𝟭 𝟵𝟮𝟭𝟲𝟱𝟵𝟴𝟬𝟳𝟳
🌐 𝘀𝗮𝘁𝗼𝗿𝗶𝗼𝗰𝘀.𝗰𝗼𝗺

17/10/2026

𝗖𝗗𝗦𝗖𝗢 𝗙𝗿𝗲𝘀𝗵 𝗜𝗺𝗽𝗼𝗿𝘁 𝗟𝗶𝗰𝗲𝗻𝗰𝗲 𝗳𝗼𝗿 𝗜𝗩𝗗 – 𝗙𝗼𝗿𝗺 𝗠𝗗-𝟭𝟰 𝗖𝗵𝗲𝗰𝗸𝗹𝗶𝘀𝘁
A ready reference for IVD importers applying for a new import licence under MDR, 2017.

𝗟𝗲𝗴𝗮𝗹 & 𝗔𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝘃𝗲 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀:
🔹 Covering Letter
🔹 Power of Attorney (Original) + undertaking from Authorized Agent – authenticated in India (Magistrate First Class / Indian Embassy / apostille)
🔹 Self-attested copy of valid Wholesale Licence or Manufacturing Licence (if any)

𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗲𝘀:
🔹 Overseas manufacturing site/plant registration (notarized)
🔹 Free Sale Certificate – country of origin (notarized)
🔹 Free Sale Certificate – USA, Australia, Canada, Japan, or EU (notarized)
🔹 Latest inspection/audit report by Notified Body/NRA/Competent Authority (within last 3 years)
🔹 NOC from Department of Animal Husbandry – for Veterinary IVD Kits
🔹 NOC from BARC, Mumbai – for Radio Immuno Assay Kits

𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗲𝘀:
🔹 ISO 13485 QMS certificate (notarized)
🔹 Production Quality Assurance / Full Quality Assurance certificate
🔹 CE Design certificate

𝗣𝗹𝗮𝗻𝘁 𝗠𝗮𝘀𝘁𝗲𝗿 𝗙𝗶𝗹𝗲:
🔹 Part 1, Part 2, Part 3, Part 4

𝗗𝗲𝘃𝗶𝗰𝗲 𝗠𝗮𝘀𝘁𝗲𝗿 𝗙𝗶𝗹𝗲:
🔹 Part 1 – Executive Summary, Description & Specification (variants, accessories), Design & Manufacturing Information
🔹 Part 2 – Regulatory status of similar device in India (approved or new IVD)
🔹 Part 3 – Essential Principles Checklist
🔹 Part 4 – Risk Analysis & Control Summary, Product Validation & Verification, Clinical Evidence
🔹 Part 5 – Analytical Studies, Specimen Type, Analytical Performance (sensitivity, specificity), Metrological Traceability, Measuring Range, Assay Definition
🔹 Part 6 – Stability Studies:
✔️Shelf life – 3 lots
✔️In-use stability – 1 lot
✔️Shipping stability – 1 lot
🔹 Part 7 – Product Insert, Pack Size, Label
🔹 Part 8 – Specimen Batch Test Report
🔹 Part 9 – Performance Evaluation Report OR Specific Evaluation Report (from Indian lab showing sensitivity & specificity)
🔹 Part 10 – Post-Market Surveillance Data + any other product information

𝗔𝗱𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹:
🔹 Correlation chart – products listed in MD-14 vs. FSC submitted
🔹 Testing method – preferably in video (if available)
🔹 Fee Challan
🔹 Legal Form (MD-14

Satori One Click Solutions LLP, help with:
🔹 CDSCO IVD Fresh Import Licence applications (Form MD-14)
🔹 Device Master File & Plant Master File preparation
🔹 Free Sale Certificate coordination
🔹 Power of Attorney authentication
🔹 Essential Principles Checklist (EPC)
🔹 Risk management (ISO 14971)
🔹 Analytical & clinical performance documentation
🔹 Stability studies (shelf life, in-use, shipping)
🔹 Performance Evaluation Reports
🔹 Indian Agent services

𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝘂𝘀:
📧 [email protected]
📞 +91 9829098077 / +91 9216598077
🌐 satoriocs.com

16/10/2026

𝗖𝗗𝗦𝗖𝗢 𝗜𝗺𝗽𝗼𝗿𝘁 𝗟𝗶𝗰𝗲𝗻𝗰𝗲 – 𝗙𝗼𝗿𝗺 𝗠𝗗-𝟭𝟰 𝗖𝗵𝗲𝗰𝗸𝗹𝗶𝘀𝘁
A ready reference for medical device importers applying for a new import licence under MDR, 2017.

𝗟𝗲𝗴𝗮𝗹 & 𝗔𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝘃𝗲 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀:
🔹 Covering Letter
🔹 Application (Form MD-14)
🔹 Fee Challan
🔹 Power of Attorney + undertaking from Authorized Agent (authenticated in India – Magistrate First Class / Indian Embassy / apostille)
🔹 Copy of Wholesale Licence / Manufacturing Licence / Form MD-42 of Authorized Agent
🔹 Constitution details of Authorized Agent

𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗲𝘀:
🔹 Free Sale Certificate / Marketing Authorization – country of origin (notarized)
🔹 FSC / Marketing Authorization – USA, UK, EU, Canada, Japan, or Australia (notarized)
🔹 Overseas manufacturing site registration – issued by competent authority (notarized)
🔹 Latest inspection / audit report by Competent Authority (within last 3 years)

𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗲𝘀:
🔹 QMS certificate (ISO 13485) – notarized
🔹 Full Quality Assurance / CE Type Examination / CE Product Quality Assurance / CE Design Certificate
🔹 Declaration of Conformity issued by manufacturer

𝗣𝗹𝗮𝗻𝘁 𝗠𝗮𝘀𝘁𝗲𝗿 𝗙𝗶𝗹𝗲:
🔹 Appendix I of Fourth Schedule, MDR 2017

𝗗𝗲𝘃𝗶𝗰𝗲 𝗠𝗮𝘀𝘁𝗲𝗿 𝗙𝗶𝗹𝗲 (𝗔𝗽𝗽𝗲𝗻𝗱𝗶𝘅 𝗜𝗜) – 𝟮𝟬 𝗦𝘂𝗯-𝗦𝗲𝗰𝘁𝗶𝗼𝗻𝘀:
🔹 Executive Summary
🔹 Descriptive information of device
🔹 Justification for Device Grouping
🔹 Product Specification (variants, accessories)
🔹 Substantial Equivalence (predicate device comparison)
🔹 Labelling Information (labels, IFU)
🔹 Device Design & Manufacturing Information
🔹 Essential Principles Checklist (EPC)
🔹 Risk Analysis & Control Summary
🔹 Verification & Validation
🔹 Biocompatibility Validation Data (if applicable)
🔹 Medicinal Substances Data (if device contains drug)
🔹 Biological Safety – TSE/BSE (if applicable)
🔹 Sterilization Validation (if applicable)
🔹 Software Verification & Validation (if software used)
🔹 Animal Studies – Preclinical Data (if any)
🔹 Stability Study Data (real-time & accelerated)
🔹 Clinical Evidence (if any)
🔹 Post-Market Surveillance Data
🔹 Batch Release Certificates / Certificate of Analysis (3 consecutive batches)
𝗔𝗱𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹:
🔹 Any other supporting documents
🔹 Copy of Permission in Form MD-27 (if Investigational Medical Device)

Satori One Click Solutions LLP, help with:
🔹 CDSCO Fresh Import Licence applications (Form MD-14)
🔹 Device Master File & Plant Master File preparation
🔹 Free Sale Certificate coordination
🔹 Power of Attorney authentication
🔹 Essential Principles Checklist (EPC)
🔹 Risk management (ISO 14971)
🔹 Verification & validation documentation
🔹 Stability studies & clinical evidence
🔹 Indian Agent services

𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝘂𝘀:
📧 [email protected]
📞 +91 9829098077 / +91 9216598077
🌐 satoriocs.com

09/10/2026

https://satoriocs.com/blogs/1024-2/

An Import Licence is mandatory if you want to import medical devices into India under the Medical Devices Rules, 2017 (MDR 2017). The licence is granted by

09/10/2026

https://satoriocs.com/blogs/how-to-get-class-b-medical-device-licence-in-india-mdr-2017/

Learn how to obtain Class B Manufacturing Licence under Medical Devices Rules 2017. Full process, documents, fees & expert help by Satori OCS.

09/10/2026

https://satoriocs.com/blogs/class-c-d-manufacturing-licence-in-india-complete-guide-2026/

16/09/2026