CDSCO Registration Process Guide: Steps To Prepare Your Medical Device Dossier
CDSCO Registration Process: Medical Device Dossier Guide
Medical Device Registration at CDSCO in India can prove difficult. However, when you know what documents are needed for registering medical devices according to medical device rules 2017 with CDSCO on the SUGAM portal, it would not be a very daunting task if you are backed by good CDSCO registration consultants.
In the case of registration of medical devices in India, if your medical devices have already been registered in any of the GHTF countries (Europe, US, Canada, Japan, Australia, and UK), your approval process in India will be facilitated. Further, the presence of a predicate device or substantially equivalent device in the Indian market is of crucial importance when it comes to deciding the approval timeline for the medical device in India.
Save time and obtain faster approval through these tips on how to prepare the dossier for India CDSCO submission and registration.
Step 1: Gather Documentation from Your QMS and Technical Files for the CDSCO Registration Process
Collecting and preparing all the necessary documents for the registration of medical devices according to the Medical Device Rules 2017 in the CDSCO through the SUGAM portal is the first step. It is based on your Quality Management System (QMS) and Technical Files, which is the base of your application in India. Even though the Article of the Medical Device Rules has a list of all the required documents, the following are some practical ways of preparing a Technical File for an MD14 Import License application in India.
Step 2: Critical Documents for Medical Device Registration in India
1. Legal Form (MD Form 15)
The Legal Form is the primary document of the Medical Device license India application which becomes the Import License Certificate after filing. The information provided in the Legal Form will become part of the import License and hence becomes an important document in the application process. The following information is required:
Name of Product and Model Number
Description of Device
Intended use
Accessories (if any)
2. Predicate Device Analysis
If there is a predicate device available in the Indian market, it could make your entire process of gaining approval easy for you. If a predicate device is available, then our team of consultants at Morulaa will help you determine this via the CDSCO database. After that, you will have to prepare the comparison study of this with a Predicate Table.
3. Free Sale Certificate and Quality Certifications
For medical device registration in India, the documents mentioned below, you can streamline the registration of your medical devices as per the Medical Device Rules 2017 with the CDSCO via the Sugam Portal
Free Sale Certificate from a GHTF country.
ISO 13485 Certification and Declaration of Conformity.
A Plant Master File (PMF) in an India specific format, including:
Manufacturing Flow Chart.
Organizational and Personnel Details.
Specific information required under the Medical Device Rules.
Step 3: Preparing the Technical Dossier
The Technical Dossier is an important aspect of your application for the approval of your medical device in India. The technical dossier shall contain:
Device Classification Criteria
Biocompatibility Tests
Toxicity Tests
Clinical Tests
Animal Testing (if any)
If your technical dossier is prepared according to the IMDRF guidelines, then the process will be easy for you. But gap analysis needs to be done.
Step 4: Uploading Documents on the Sugam Portal for a Medical Device License India Application
Upload the prepared documents to the Sugam Portal for your medical device license application in India. The main aspects are as follows:
Classification of Medical Devices: Classification ensures no unnecessary delay.
Government Fees: Government fees differ based on the type of medical device.
Step 5: Managing Queries in the CDSCO Registration Process for Medical Device Approval in India
After submission, CDSCO can raise doubts or ask for more information. Manufacturers have to be ready to
Answer queries from reviewers.
Undergo Special Expert Committee reviews if necessary.
Why Choose CDSCO Registration Consultants at Morulaa HealthTech?
CDSCO Registration Consultants in India:
The CDSCO registration consultants in Morulaa HealthTech, which is considered among the best medical device regulatory consultants in India, excel in the following aspects:
Predicate device evaluation and technical file creation.
Auditing and solution development.
Support in getting all types of devices (classes A to D) registered under CDSCO registration.
We assist device manufacturers in launching their products in India effectively, and make sure that these products meet India’s regulations.
Additional Resources
By following this guide and appointing Morulaa as Medical device Importer for India, you can simplify the CDSCO registration process, complete medical device registration in India, get timely medical device approval in India, and sell your products.
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