Introduction: Central Drugs Standard Control Organisation
Hey Corpseed readers, today we are going to tell you about how you can import medical devices in India. Medical devices are one of the biggest market in India but manufacturing of all medical devices is not that simple so we need to import some types of medical devices. Medical devices come under some regulations in India. There are some compliances required for the import of medical devices. In India, CDSCO (Central Drugs Standard Control Organisation) regulates the import of medical devices. CDSCO is a government body that is responsible for the authentication of all manufactured and imported drugs. CDSCO maintains the standards for manufacturing and import medical devices by coordinating with the different stare drug control organizations.
Table of Contents
- Introduction: Central Drugs Standard Control Organisation
- What are the requirements to import medical devices in India?
- What is the process to Import Medical device in India?
- What is the process for the Import License Application?
- Non-Regulatory Medical Device Registration
- What Is The Validity Time Line Of A Cdsco Medical Device Import License?
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According to the new guidelines of CDSCO (Central Drugs Standard Control Organisation), Importers would not be able to import any medical device if they don’t take the CDSCO medical device import license before the specified deadline (1st October, 2022). There is a specified procedure for the CDSCO Import license for medical device. The CDSCO medical device Import license is essential for all medical device import in India. Importer can import those medical devices which are mentioned in notified medical device list of the CDSCO.
What are the requirements to import medical devices in India?
- Applicant have to mention the Generic Name/Product Name of the medical device.
- Applicant importer need to specify the Brand Name in the application.
- Intended Use of that specific medical device have to be mentioned on the application.
- Applicant have to mention the Material of construction for that medical device.
- Applicant need to specify the Class (A, B, C, D) of the medical device on the basis of the risk level with that medical device.
- Applicant need to mention the Product dimensions and packed size of the medical device which he is importing.
- Product description and classification of medical device is really important for the CDSCO medical device import license. Product description and classification should be specified on the basis of notified product list of CDSCO.
What is the process to Import Medical device in India?
Registration of the Applicant: Primarily, Applicant have to register himself on the CDSCO online registration portal. In case applicant already have an active CDSCO registration then he/she can directly proceed to the import license application. Here is a list of steps for CDSCO medical device import license:
- Primarily, Applicant need to submit an online form.
- Applicant have to upload the required documents on the CDSCO online portal. Documents such as Applicant’s Aadhar card, copy of BE or BA Site registration (if applicable), Government undertaking from a government authority, Etc. would be required.
- In case CDCO rejects your registration application, they will specify the reason behind it. Applicant can fulfil the required requirements to get CDSCO medical device portal registration.
What is the process for the Import License Application?
CDSCO medical device import license is required to import all the medical devices for commercial purposes. Here is a step-by-step procedure for the CDSCO medical device import license:
- Once the applicant is done with the registration part, they need to apply for the CDSCO medical device import license.
- Applicants need to submit an online form which is also known as MD-14. Applicants needs to fill the required details such as device classification, brand name, Description of the product and intended use of it.
- Now applicants need to upload all the required documents such as a Covering letter, Power of attorney, and so on. You can check the document checklist through this link https://corpseeds.blob.core.windows.net/corpseed/MD14.pdf.
- Once applicant is done with the document uploading part, they need to pay the application fees for the CDSCO medical device import license.
- Fees structure for the CDSCO medical device import license could differ on the basis of the Class of the medical device.
|CLASS OF MEDICAL DEVICE||APPLICABLE REGULATIONS||FEES FOR THE ONE SITE (In Dollars)||FEES FOR EACH DEVICE (In Dollars)|
|Class C or D||34(2)||3000||1500|
|Class C or D (For IVD’s)||34(2)||2000||500|
- After submitting the fees for the CDSCO medical device import license, you can expect your license within 6-9 months after the application submission.
- In case, some query raises from the CDCO department, Applicant need to give a proper justification on that and upload the revised documents as well.
- Applicant would receive the import license in the form of a document which is also known as MD-15.
Non-Regulatory Medical Device Registration
"Non- Regulatory Medical Devices" means non-notified medical devices (Except Class C and D devices) that are required to be submitted as part of the new mandatory registration process of CDSCO. The importer have to mention the file number which generated from the non-regulatory registration process on the medical device's label before selling it commercially in the market. The last date is October 1, 2022 for Class A and B devices and for Class C and D devices, 1st October 2023 is the last date for the non-regulatory registration.
What Is The Validity Time Line Of A Cdsco Medical Device Import License?
The validity time line of the CDSCO medical device import license is valid for 5 years, after 5 years license holder need to pay the retention fees for the CDSCO medical device import license. So, we could say that the license would be valid till the applicant pay the retention amount of CDSCO medical device import license. The licence retention fee must be paid each time before the period of five years otherwise the license could be cancelled or suspended.
Corpseed is one of the leading medical device regulatory consulting company in India. We always try to help our clients in making technical files for the complete licensing process, we try to give the complete regulatory compliance service and also solve the queries raised by the regulators/departments. Corpseed is providing complete Compliance services, system implementation, licensing, regulatory approvals and certifications on time. For more information, you can contact us through our website. Our consultants are there to help you.
This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.
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