1. Why is the MD-14 Legal form a critical part of your SUGAM online application
The CDSCO (Central Drugs Standard Control Organisation) MD 14 form acts as the basis for your import license. It includes important details such as device classification, intended use, shelf life, and product families. All the information in this form must align with your medical device technical files. This will fast-track your CDSCO MD-15 import license and help you to comply with the regulatory process in India.
2. Documents Required for MD-14 Form Application
A detailed checklist for documents required for MD-14 form can be found here. The below files have to be kept in hand for referencing and filling out the MD-14 application.
Expert Tip by Morulaa HealthTech: |
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Labels of the Medical Device: Must include the model name and model number. Also the labels must contain the information of the Morulaa India Authorized Importer |
Free Sale Certificate (FSC): Should specify the model name and model number to match the CDSCO MD14 form and POA |
Instructions for Use (IFU): Must cover details such as intended use, model name, model number, and accessories as submitted in the documentation for the regulatory process in India. They can be prepared similar to the IFU requirements under EU-MDR |
Sample Invoice: Must list the model name, model number, and description. This information must match the CDSCO import license form MD-15 |
Shelf Life Data: Include results from real-time and accelerated ageing tests that support the shelf life mentioned in the MD-14 legal form. The shelf life documents must match the data uploaded in the SUGAM online checklist for the MD-14 application |
Power of Attorney: Ensure all details align between the MD-14 checklist and the Power of Attorney, particularly the product details. Additionally the POA is in the name of Morulaa or your India Authorized Importer |
Accessories: List only medical device accessories, not non-medical accessories. Include their classification and intended use. |
Grouping Devices into Product Families:
For more guidance on grouping product families for medical device registration in India, Case Study: While grouping products to minimize government fees might seem like a good strategy, improper grouping often leads to delays and rejections.
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Classification: Indicate the classification of the device (Class A, B, C, or D) as per the Medical Device Rules 2017. This is similar to the EU MDR classification |
Predicate Device: Specify if a predicate device is available in India. |
Notified Category: Select one of the 28 categories (1) Disposable Hypodermic Syringes, (2) Disposable Hypodermic Needles, (3) Disposable perfusion set, (4) Cardiac Stents, (5) Drug Eluting Stents, (6) Catheters, (7) Intra Ocular Lenses, (8) I.V Cannulae, (9) Bone Cements, (10) Heart Valves, (11) Scalp Vein set, (12) Orthopaedic Implants, (13) Internal Prosthetic Replacements, (14) Ablation devices, (15) Nebulizer, (16) Blood pressure Monitoring devices, (17) Digital Thermometer, (18) Glucometer, (19) All Implantable Medical Devices, (20) CT SCAN, (21) MRI Scan, (22) Defibrillators, (23) Dialysis Machine, (24) PET Equipment, (25) x-ray machine, (26) Bonemarrow cell, (27) Organ preservative solution |
Common Errors in MD-14 Form Applications and How to Avoid Them
Mismatch of Model Names/Numbers: Ensure consistency across all documents.
Incorrect Classification: Verify the classification aligns with Central Drugs Standard Control Organisation(CDSCO) standards as per the SUGAM online database
Shelf Life Discrepancies: Ensure the shelf life matches data from real-time and accelerated ageing tests as per the documents required for the MD-14 form
Incomplete Accessories Section: All medical device accessories must be listed with proper classification and intended use in the MD-15 import license
Frequently Asked Questions:
The MD-14 legal form is the application that the authorised Indian agent needs to fill on their Sugam online portal on behalf of the manufacturer of medical devices. This form is a critical certificate as it leads to the MD-15 import license. All data in this form, such as the model number, model name, and shelf life, must match to avoid issues in obtaining the No Objection Certificate (NOC) from the ADC at customs.
The MD-14 application process takes about 2 to 3 weeks to prepare when there are multiple model numbers. This is because the Sugam portal does not provide an option to directly upload an Excel sheet of model numbers. If a manufacturer has only 1 or 2 model numbers, the MD-14 legal form can be created immediately. However, for manufacturers like dental companies, spinal implant companies, or capital equipment companies with many SKUs or accessories, it can take a few weeks to manually input the data into the Sugam online portal by the CDSCO.
No, you cannot amend details in the MD-14 legal form after submission. Therefore, great care must be taken while preparing the application. If changes are required, a special request must be submitted to the CDSCO for consideration.
How Morulaa as your India Authorized Importer Can help prepare the MD-14 Form Application:
As a trusted partner for submission of documents online for medical devices, Morulaa as your Indian Authorized Importer offers end-to-end support for navigating the CDSCO SUGAM portal and ensuring compliance with the Medical Device Rules 2017. As India’s leading regulatory consultant, we help prepare the MD-14 form application to reduce the number of queries during the NOC stage from the ADC at Indian Customs
How We Support:
Document Verification: Ensuring uniformity across labels, FSC, IFU, invoices, and legal documents like Power of Attorney.
- Accurate Filing:Expertise in filling more than 500 CDSCO MD-14 forms, including handling shelf life and product family grouping.
Regulatory Alignment: Reviewing all documentation to meet CDSCO compliance standards.
- Comprehensive Support: Helping you manage the entire medical device import license application process in India.
Conclusion: Simplifying MD-14 Form Applications
Filling the CDSCO MD-14 form is an important step in securing an import license for medical devices in India. Attention to detail in grouping product families, aligning documents, and ensuring compliance with shelf life and technical data can streamline the process and minimize delays.
For expert guidance, trust Morulaa HealthTech, India’s leading medical device consultant for CDSCO compliance. Contact us today to begin your registration process or access a sample MD-14 form template.