Preparing a Device Master File (DMF) as per the Medical Device Rules, 2017: A Guide by Morulaa HealthTech
Preparing Your Device Master File under MDR 2017 in India
As the top Healthtech consultants in India, we make the process of preparing the Device Master File (DMF) easier, following the Medical Device Rules and regulation (India MDR, 2017). We work as an authorized agent in India to prepare the DMF according to the CDSCO guidelines of medical devices and make it ready for submission to the CDSCO Sugam Portal for medical devices.
Get in Touch with us to get a CDSCO device master file template for medical devices. This template follows medical device regulation in India and helps you to collect the necessary information for the regulatory process with the CDSCO.
What is a Device Master File (DMF)?
DMF stands for the "Device Master File" which is required to determine the safety, performance, and quality of your medical device. DMF is similar to the technical file of your medical device. DMF plays an important role in the medical device approval process in India. DMF contains vital details about your product in technical and regulatory terms, making it a significant component of the CDSCO medical device registration process in India.
How Morulaa Creates Your Device Master File
Morulaa HealthTech individualizes the creation of your DMF process based on the rules of CDSCO, using your own technical dossier as a base. Here's how we use your data and follow India-specific regulations:
1. Technical File Review and Consolidation
Morulaa starts with an assessment of your technical file of the medical device that ensures that your technical file includes all the necessary data for the CDSCO medical device regulation process.
Tips by Morulaa Experts:
Provide the Technical File Document for Each Device Family: This document, prepared for submission to EU or FDA, must include device description, product specifications, material, and principle of operations.
Single Combined DMF for Each Device Family: All the model numbers, accessories, and other components mentioned in the MD-14 form must be also included in the corresponding technical files.
This helps to make sure that everything is consistent and complete for every device family to be registered under medical device regulation rules in India.
2. Collection of India Specific Data
Regulatory requirements in India are stricter than international ones, and Morulaa prepares the DMF to meet them.
Expert Advice from Morulaa:
Complete the Form Entitled "v101_India Specific DMF Information": The form is located within the folder named "1_Introduction_Technical File" and has to be filled separately for every family of devices based on CDSCO classification of medical devices in India
The form contains India-specific information about safety, costs and other requirements for CDSCO medical device approval.
3. Executive Summary
The DMF contains an executive summary that includes:
Marketing History: Information regarding the countries in which the product has been marketed, date of marketing, and quantity sold.
Domestic Pricing: Estimated price on an EXW basis from the country of manufacture.
Approvals: List of approvals along with the medical device classification, approved indication, shelf-life, and any rejections/withdrawals.
4. Device Description and Specifications
This part gives comprehensive information related to the device such as:
Different types of the device and the function of each.
Characterization of materials used in the device that come into contact with the human body either directly or indirectly.
Radiation protection data (if any).
5. Risk and Safety Data
Morulaa gathers information about:
SAE (Serious Adverse Event): Timeline, number of events and batches involved.
FSCA (Field Safety Corrective Action): Description of actions, geography affected, and causes for taking such actions.
6. DMF Creation and Finalization
The Morulaa team develops DMF using the technical files and India specific data provided.
Expert Tips by Morulaa:
Review and Sign the Completed DMF: After developing the DMF, you need to review and sign it on your company letterhead.
7. Submission to the CDSCO Sugam Portal
The finalized DMF is to be uploaded on the CDSCO Sugam Portal for medical devices, ensuring compliance with format and requirements for CDSCO medical device guidelines in India.
Why Choose Morulaa HealthTech for Your Device Master File?
Morulaa HealthTech: As one of the most proficient medical device regulatory consultants in India, we present our expertise in DMF preparation. As your authorized agent in India, we guarantee:
DMF Preparation: Utilizing your technical documents to prepare a Device Master File according to Medical Device Rules, 2017, suitable for CDSCO medical device regulatory process in India.
End-to-End Services: From data collection till Sugam Portal filing, we provide complete services.
Effortless Regulatory Compliance: Handling all CDSCO queries easily, considering our proficiency as one of the most proficient medical device consultants in India.
Conclusion
Using the advice provided by Morulaa along with our experience in regulations, manufacturers can prepare and submit their Device Master File according to the Medical Device Rules 2017. This will ensure that medical devices enter the Indian market promptly. Since we specialize in regulations related to medical devices in India, all your needs are addressed appropriately.
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