The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body that supervises all medical devices and their permissions in India. All non-notified In-vitro Diagnostic (IVDs) medical devices, excluding those already under the notified category of the medical device need registration with the CDSCO.
An Indian manufacturer or foreign importer who intends to obtain a Registration Number for the non-notified invitro diagnostics can apply through this service. The applicant must file an application for Registration through an identified online portal (SUGAM) of the Ministry of Health and Family Welfare.
Any foreign importer or a local manufacturer who wishes to acquire a Registration Number of non-notified in-vitro diagnostics (IVDs) can apply for this service.
The Applicant must follow the following process:
Step 1: The applicant must visit the link:https://cdscomdonline.gov.in/NewMedDev/Homepage |
Step 2: The applicant must register on the online portal by clicking on the registration link. |
Step 3: The applicant should have a valid email-id and mobile number for registering on the portal. |
Step 4: The applicants need to upload the following documents for registration on the portal:- |
Step 5: The applicant must complete verification of the registration process through the four-digit OTP received on the registered mobile number. And after verification, the applicant can login and proceed with further procedures. |
Step 6: The applicants must upload all the relevant documents according to the Registration Number checklist. |
The essential documents required for this voluntary registration are:
The importer and the manufacturers should act in accordance with the safety and quality-related requirements.
Once the validity period of the Registration Number expires, the terms and conditions for the Import License and Manufacturing License are applicable.
The importer and the manufacturers should act in accordance with the safety and quality-related requirements.
The registration process includes several steps to obtain approvals. The process involves registration, undertaking, and uploading the documents, complying with the given rules and regulations. We at CliniExperts, make sure that our expert team creates your registration easy and quick so that you can focus on more important aspects of your product launch...
Registration for in-vitro diagnostic medical devices for manufacturing can be time-consuming and tedious; we at CliniExperts will take care of all the registration procedures while you focus energies on planning your product launch. From the application process forms to undertaking a license test, we assist in every registration aspect to help you smoothly start the manufacturing process.
Get Your Import License for In-Vitro Diagnostic Kits (IVD) and Medical Devices with CliniExperts. Hassle-free assistance in providing Import License of Form MD 15.
Yes. The ISO 13485 Certificate is a mandatory requirement for obtaining the Registration Number for the in-vitro diagnostic devices. Therefore, all the manufacturers or importers should have ISO 13485 Certificate before applying for this service.
Any foreign importer or manufacturer in India can apply for a Voluntary Registration Number.
To know more about the risk class of non-notified devices, you can refer to the CDSCO Classification List.