Step by Step CDSCO Guide to Predicate Table Creation for Medical Device Registration in India
CDSCO Predicate Table Guide for Medical Device Registration
Steps in Preparing a Predicate Table
One of the key factors that can make or break the application of a manufacturer in India and grant approval of the import license is the presence of a predicate product available in the Indian market, according to the Medical Device Rules 2017. CDSCO has clearly provided guidelines as to how a predicate product should be. Registration Strategy for Medical Devices Application with the CDSCO in India is essential in ensuring that your import license is successfully approved. Comparison should be based on critical points including intended use, material of construction, and design features. Below is a comprehensive step by step guide in preparing a predicate table. Tips from Morulaa HealthTech - an Indian Medical Device Regulatory Consultant are included.
Step 1: Open the Clinical Evaluation Report (CER)
Start off by analyzing the Clinical Evaluation Report (CER).
The CER usually has a global comparison to the predicate devices.
dentify the names of the equivalent devices of predicate devices listed in the CER that are available in the Indian market.
Expert Tip by Morulaa HealthTech:
A predicate device is a device which is exactly the same as your device in regard to material used for making the device, purpose and design of the device. While submitting, it needs to be confirmed that there is conformity in these regards while choosing your predicate device to avoid any delay in your application. For easy handling of regulatory affairs internationally, such as in India, predicate devices play an important role.
Step 2: Research Predicate Devices on the CDSCO Database
The CDSCO database portal is available online at the Sugam website
Make use of the search tool on the website and extract predicate devices from the same. You get the name of the license holder through this website, however not the name of the legal manufacturer. The information can be downloaded into an Excel format.
Expert Tip by Morulaa HealthTech:
In case the predicate device is not approved by the CDSCO, then the application will have to go through an extra review through MD-26. In this regard, a Special Expert Committee (SEC) will be formed that will require:
Clinical data from published studies.
Evidence of safety and efficacy among Indians.
All available clinical and safety data.
The SEC may either approve or demand extra clinical studies in India after being satisfied. Hiring an Indian regulatory consultant for medical devices like Morulaa HealthTech can save you the hassle.
Step 3: Validate Substantial Equivalent Predicate Devices
Compare the predicate devices present in your CER with the available predicate devices in the Indian market.
Make note of the license number of the substantial equivalent of the predicate device which is similar to your product.
Expert Tip by Morulaa HealthTech:
In case there has been any past sales or registration in India, the grandfather clause applies and in such scenarios: A declaration is required that the product is the same as the previously registered device. Reason for re-application along with the number of units sold in India annually.
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:
Import license number, web address of the predicate device or electronic IFU may be used to acquire necessary information.
Since the shift towards European MDR 2017/745, most electronic IFUs can be found on the Internet.
Another way to make this comparison is using websites such as Yoda.
Step 5: Insert the Predicate Table into the Technical Dossier
After completion, include the predicate table in your Technical Dossier or Device Master File relating to the product.
Expert Tip by Morulaa HealthTech:
Make sure that your comparison table is detailed enough to adhere to the CDSCO standards.
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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