Easily Secure CDSCO Registration for Class A Devices

Stringent regulations are in place for all medical devices entering the Indian market. Recently, CDSCO has updated its regulatory requirements for Class A non-sterile and non-measuring medical devices. This move is aimed at helping medical device companies establish businesses without undergoing the painstaking process of license application. As per the latest CDSCO guidelines, you can sell/manufacture certain Class A medical devices with a simple registration. This will help do away with the hassle of securing a CDSCO license. Although a CDSCO license will not be required, CDSCO registration is mandatory for Class A non-sterile and non-measuring medical devices. We at Pharmadocx Consultants have extensive knowledge of the CDSCO regulatory guidelines. Our team of experts will help you identify whether your device will require a license or simply a CDSCO registration. Moreover, we will help you easily secure the CDSCO registration for Class A devices (non-sterile and non-measuring). 

Mandatory CDSCO registration for Class A devices

For easily securing the CDSCO registration for Class A medical devices, fill out the form below.

This aforementioned list provides an overview of the medical devices you can manufacture and sell without procuring a CDSCO license. To get a full list of medical devices that no longer require a license but only a registration contact us. We will be more than happy to provide the full list of potential medical device business exempt from license requirements. Notably, starting a medical device business for all the aforementioned devices will mandatorily require a CDSCO registration. The Pharmadocx Consultants team will streamline the CDCO registration for Class A devices so that you can start your business without regulatory hiccups.

Documents required for securing the CDSCO registration for class A devices

For Class A medical device manufacturers

• Manufacturing company and facility’s name and address
• Details of the medical device whether it is sterile or non-sterile. Additionally, generic name, model number, class, intended use, material of construction, and dimensions have to be mentioned.
• Shelf life or expiry date of the device.
• Undertaking duly signed by the manufacturer stating that the proposed device is a non-sterile and non-measuring Class A medical device.
• Undertaking duly signed by the manufacturer stating that the information furnished is accurate.
• The manufacturer is required to certify the device conforms with the Essential Principles Checklist (EPC).
• The manufacturer is required to certify the medical device complies with the standards specified in Medical Device Rules, 2017.
• Certificate of compliance with the ISO 13485 and BIS standards

For Class A medical device importers

• Medical device importer’s name and address.
• Details of the medical device whether it is sterile or non-sterile. Additionally, generic name, model number, intended use, class, material of construction, and dimensions have to be mentioned.
• Shelf life or expiry date of the device.
• Undertaking duly signed by the manufacturer stating that the proposed device is a non-sterile and non-measuring Class A medical device.
• Certificate of compliance with the ISO 13485 and BIS standards
• The manufacturer is required to certify the device conforms with the Essential Principles Checklist (EPC).
• The manufacturer is required to certify the medical device complies with the standards specified in Medical Device Rules, 2017.
• Undertaking duly signed by the importer stating that the information provided is true.
• Free Sale Certificate issued by the regulatory authority of the country of origin.
• Self-attested copy of the overseas manufacturing facility in the country of origin issued by competent authorities

Steps for securing the CDSCO registration for Class A devices

1. Login/Signup on the official CDSCO online portal SUGAM. Register on the portal with a valid email address and mobile number.
2. Upload a government id proof. Company documents, such as GST number and CIN, will have to be uploaded.
3. Upload the aforementioned necessary documents.
4. Then, proceed with the CDSCO registration process.

Securing the CDSCO registration for Class A devices is a cumbersome task. First, you have to prepare and compile all the necessary supporting documents. Then, you have to navigate through the complex CDSCO registration process. As a medical device company, it is not possible to stay abreast of the latest CDSCO regulations. This is where our team of experts comes into the picture. We at Pharmadocx Consultants are committed to make the CDSCO registration process a seamless for you.

CDSCO registration number has to be mentioned on the medical device label

Non-sterile and non-measuring Class A medical devices mandatorily require CDSCO registration. Although they have been exempted from CDSCO medical device license, manufacturers and importers will still have to secure a CDSCO registration. After completing the registration process, the applicant will receive a CDSCO registration number. This CDSCO registration number has to be mandatorily mentioned on the label of the medical device.

Pharmadocx Consultants: Your trusted ally for securing CDSCO medical device Class A registration

We at Pharmadocx Consultants simplify the medical devices registration process for our customers.  From determining the applicable regulatory requirements, identifying medical device class to assistance in obtaining CDSCO registration, Pharmadocx Consultants is your go-to-partner. Notably, manufacturing or importing Class A (non-sterile and non-measuring) medical devices without the CDSCO registration will attract regulatory sanctions. We will help you obtain the CDSCO registration for Class A devices within a short span of time in a hassle-free manner. With our support, you will have a smooth sailing Class A medical device regulatory journey.