If you are a medical device importer or going to enter into this import business then know about CDSCO Import License. Here we streamline the services of CDSCO Import License Consultant For Medical Devices.
Our dedicated team will help you fill out the form for the Import license and work on your behalf for the approval of the CDSCO. Through our guidance, you can ensure that your medical device fulfills the needs of the CDSCO Import.
What Is a CDSCO Import License?
The CDSCO Import License is an approval document from the side of the CDSCO (Central Drugs Standard Control Organization). It allows the regulation of medical devices, cosmetics, and pharmaceuticals to Importers into the country. The CDSCO License import is necessary to ensure that the medical products and services are safe to use. It shows that the medical devices and services meet the necessary quality, safety, and efficacy standards by the Indian government.
What Is MD-15 Registration For Medical Devices?
MD 15 is a registration issued by the CDSCO for the importer to import medical devices into the country. It is mandatory for all devices that is related to the medical industry.
What Is The Latest Update By CDSCO For Medical Device Registration?
In the recent update on 1 October 2023, CDSCO announced that the medical device registration of Import license is mandatory for importers. Without an Import license for medical devices, no one is allowed to regulate medical devices in the country. MD 15 Import License is mandatory for all importers.
Non-sterile and non-measuring Class A devices are free from the MD 15 license. But before importing into India importer must register those non-sterile and non-measuring devices on the CDSCO SUGAM portal.
For the hassle-free MD 12 import license and Class A Device registration choose a medical device registration consultant.
Are You Looking For A Medical Device Registration Expert Consultant?
If you are looking for expert guidance for medical device registration in India then here you will find the solution of it. We are CDSCO registration and medical device consultant expert in India and you can book our free consultancy anytime.
How to Get a CDSCO Import License for Medical Devices?
To obtain the CDSCO Import License For Medical Device you have to follow a straightforward and basic processor. The importer must submit an application form, and supporting documents including information about the medical device, the importer, and the manufacturer. Later CDSCO will review the document and check whether you are eligible to grant the CDSCO import license or not.
Here are the basic steps to follow for the CDSCO Import License In India:-
Register On The CDSCO SUGAM Portal
The first step is to register on the CDSCO SUGAM Portal with a valid email address, Aadhar card, PAN, or any identity proof. In this registration, you have to attach the address proof of the organization for example GST Certificate.
The hard copies of all the documents will sent to the CDSCO office in Delhi and they will check it and grant the registration approval.
Apply for MD 15 License
You must have to fill out the MD 15 form to grant the MD 15 import license in India for better regulation of medical devices. An Indian-authorized agent can apply for the MD 15 importer license of Medical Devices.
List Of Documents You Need to Submit
For instant approval you have to attach the few necessary documents with the application form:-
- Power of attorney
- Device master file
- Free sale certificate
- CE certificate, if any
- Manufacturing license
- Site master file
- ISO 13485:2016 certificate
Pay Free According To The Government
According to the Medical Device Rule 2017 pay the fee. The fee of the registration depends on the classification and the total number of medical devices.
Review Of Documents By CDSCO
After the submission of the form and the documents, the documents will be passed to the CDSCO office for verification and review. They verify that all the documents are according to the medical device rule 2017.
Audit The Overseas Manufacturer (If Needed)
If they find anything conscious they can visit the manufacturing site overseas.
If Needed CDSCO May Ask For The Additional Documents
For further and additional verification, CDSCO may ask for further information and documents related to the device. The queries were addressed by the applicant with proper jurisdiction and documentation.
Issue Of License
If the CDSCO authority finds everything in order then they will issue the MD 15 Import license for medical devices. After that, the importer can import the medical devices into India.
Once you get the MD 15 registration in India then you can simply import anything related to medical devices in India.
Why Choose Medical Device Registration For the CDSCO Import License?
For the CDSCO Import License, you can choose the Medical Device Registration Services. Because we are an expert team of consultants. We specialize in work and provide free consultancy to the users. Our experts will assist you in documentation, submission, and other processes of medical device registration. Our consultancy is cost-effective and provides a one-stop solution to each client.
Frequently Asked Questions
What Is The Validity Of CDSCO Import License Of Medical Device?
The CDSCO Import license is valid for 5 years from the date of granted or renewed.
What Is The Cost Of CDSCO Medical Device Import License?
The cost of a medical device import license depends on the class of medical devices. So, consult with the best expert before applying for medical device registration in India.