Predicate Table Creation for Medical Device Registration in India Description
One of the critical documents that determine the success of a manufacturer’s application in India and the approval of the import license is the availability of a substantial equivalent device available in the Indian market, as per the Medical Device Rules 2017. CDSCO has clearly defined what constitutes a predicate product. Registration Strategy for Medical Devices Application with the CDSCO in India plays an important role in ensuring the successful approval of your import license. The comparison must focus on key aspects such as intended use, material of construction, and design characteristics. Below is a detailed step-by-step guide to creating a predicate table, along with tips from Morulaa HealthTech who is an Indian Medical Device Regulatory Consultant.
Step 1: Open the Clinical Evaluation Report (CER)
Begin by reviewing your Clinical Evaluation Report (CER).
Typically, the CER includes a comparison with predicates globally.
Extract the names of the substantial equivalent devices of predicate devices mentioned in the CER that are available in the Indian market.
Expert Tip by Morulaa HealthTech
A predicate device is one that is identical to your device in terms of material of construction, intended use, and design characteristics. During submission, we need to ensure that these aspects align during your predicate selection to avoid delays in application.For smooth navigation of regulatory affairs for international markets like India, a well-chosen predicate device is very important to streamline the process in India.
Step 2: Research Predicate Devices on the CDSCO Database
Visit the CDSCO database portal available online on Sugam
Use the search option to look up the extracted predicate devices. The website provides the name of the license holder, but not the legal manufacturer. Export the search results as an Excel file, which contains a column for the legal manufacturer's name. This makes identifying predicates easier.
Expert Tip by Morulaa HealthTech
If the predicate device is not accepted by CDSCO, your application will be referred for an additional review via MD-26. This process involves a Special Expert Committee (SEC), which will require:
Randomized published clinical data.
Proof of safety and efficacy in the Indian population.
All relevant clinical and safety data.
If satisfied, the SEC may grant permission or request additional clinical trials in India. Working with an Indian medical device regulatory consultant like Morulaa HealthTech can help your predicate selection, reducing the likelihood of this lengthy review process.
Step 3: Validate Substantial Equivalent Predicate Devices
Cross-check the predicate devices found in your CER with those available in the Indian market.
Note down the import license number of the substantial equivalent device of the predicate device that matches your product.
Expert Tip by Morulaa HealthTech
If you have previous sales or registration in India, you may qualify under the grandfather clause. In such cases:
Provide a declaration that the product is identical to the previously registered device.
Include the reason for re-application and state the number of units sold annually in India.
Step 4: Populate the Predicate Table
Using the details found in the CER and the CDSCO database, fill in the predicate table with the following structure:
Section | Your Product | Predicate 1 |
Product Details | ||
Intended Use | ||
Indications | ||
Materials | ||
Design Characteristics | ||
Mode of Action | ||
Contraindications | ||
Biocompatibility | ||
Product Specification | ||
Storage | ||
Packaging and Labeling | ||
Advantages | ||
Disadvantages |
How to Fill the Table:
Use the import license number, predicate device's website, or electronic IFU to gather relevant details.
With the transition to European MDR 2017/745, most electronic IFUs are now available online.
Alternatively, use resources like the Yoda database to complete the comparison.
Step 5: Insert the Predicate Table into the Technical Dossier
Once completed, add the predicate table to your Technical Dossier or Device Master File for the specific product.
Expert Tip by Morulaa HealthTech
Ensure the comparison table is detailed and aligns with the format and requirements of the CDSCO to minimize rejection risk.
Step 6: Upload Predicate Information on the Sugam Portal
Your authorised Indian agent will upload the predicate details to the Sugam online portal.
Ensure the legal form is filled, and the checklist is completed before submission
Why Choose Morulaa HealthTech?
As a leading consultant for predicate analysis in India for medical devices, Morulaa HealthTech ensures that your predicate table complies with the Medical Device Rules 2017. From Suitable Predicate Device identification to submission on Sugam, Morulaa simplifies the process for seamless application approval. Our approach includes comprehensive support for the Demonstration of Substantial equivalence device for the MD-14 import licence, ensuring compliance and avoiding delays.
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