The CDSCO is the National Regulatory Authority (NRA) of India, which works under the Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare, Government of India. CDSCO, a body that works under the Drugs and Cosmetics Act, is accountable for the approving of drugs and laying down the standard for drugs, to conduct clinical trials, to take control over the quality of Imported Drugs, etc. From April 1, 2021, CDSCO, a government agency under the Ministry of Health and Family Welfare, has issued an order to regulate CT scanners, all implantable devices and MRI machines. Medical devices such as implantable devices, CT scans, MRIs, defibrillators, PET scanners, X-ray machines and cell separators used in dialysis will all require an import/manufacturing licence from either the Central Licensing Authority or a State Licensing Authority in order to enter the country. In this blog, we are going to discuss CDSCO Registration Certificate for CT Scan Machine.
Regulatory Bodies Responsible for the Registration of Medical Devices in India
- Central Drugs Standards Control Organization (CDSCO): It is the main regulatory body in India, under the Directorate General of Health Services (DGHS), Ministry of Health & Family welfare, which regulates pharmaceuticals and medical devices.
- DCGI: It is the head of CDSCO, and is responsible for approval of quality drugs and cosmetics to be sold in the country and to regulate clinical trials.
- The Drugs and Cosmetic Act and Rules: These are the set of rules that regulates the Manufacture, Import & Distribution of Drugs in India.
Medical Devices classification under CDSCO
In general, medical equipment are categorised based on the risks they pose; however, a medical device’s absolute risk classification is determined by how it is intended to be used and what its intended purpose is. Medical Devices IVD are classified into four categories based on their evidence for use and risk. Under the new regulations, devices are regulated using a risk-based approach. A device’s intended use, as well as its technological properties, influence how much regulation it receives. The new system divides devices into four classes – A, B, C, and D, where Class A and B presenting the least risk to patients and Class C and D presenting the greatest risk.
Who are eligible for CDSCO Registration Certificate?
There are a few applicants who are allowed to apply for an online CDSCO Registration certificate:
- Indian Agents, and
- Foreign Enterprises holding Indian Subsidiary.
Important Documents required for CDSCO Registration Certificate for CT Scan Machine
Following are some vital documents required for CDSCO Registration Certificate for CT Scan Machine:
- Form 40
- ISO 13485 Certificate
- Full quality assurance certificate
- CE Design certificate
- Device master file
- Plant master report
- Undertaking that only authentic details are provided
- Free sale certificate/ certificate from the foreign government
- Certificate of Marketability from GHTF (The European Union, Canada, Australia, Japan & The United States)
Procedure for Obtaining Online CDSCO Registration Certificate for CT Scan Machine
The Registration process for CDSCO is completely online. Here are the steps to get registered with CDSCO through the online CDSCO Portal:
- Go to the CDSCO Registration portal.
- After that, you need to apply for registration by filling the application form (Form 40).
- Upon accessing the Application Registration page, enter all the requested information, including:
- Type of Applicant,
- Mobile Number,
- Email ID.
Complete the Registered Indian Address Form, which includes the following information:
- Name and Type of Organization,
- Phone Number,
- Upload the proof of the business address.
- After submitting a complete application for the registration, you will receive a confirmation link to your registered email address to confirm your registration. Then you must click the provided link to activate your CDSCO account.
- Upon clicking the confirmation link, the application for CDSCO Registration for CT Scan Machine will be forwarded to the relevant Department for approval.
- Once your CDSCO Registration for CT Scan Machine application has been approved, an approval email will be sent to your registered email address.
Time taken for CDSCO Registration process of Medical Devices:
Commonly, it takes around 6 to 8 months to register Medical devices in India, unless there’s a review required by Technical Presentation or Subject Expert Committee (SEC). In case, if the Technical Presentation or Subject Expert Committee review is required, the registration process is extended by 3 to 6 months. Once registration is completed, the registration certificate remains valid for up to 3 years from the registration date, unless it is cancelled or suspended by the DGCI authority.
Import/Manufacturing License under Medical Devices Rules, 2017
According to the provisions of the Medical Devices Rules, 2017, the existing Importer/manufacturer of medical devices who has applied for a licence for Import/ Manufacturing, in the Central Licencing Authority or State Licensing Authority will be accepted as valid. Devices imported or manufactured, can be imported for up to six months after the order has been placed. Additionally, the permit can remain valid until a decision is made by the Central Licencing Authority or the State Licensing Authority.
Over the next few years, India’s medical device workspace is likely to expand due to more people caring about their health, an emerging middle class, and government health programmes. In the year 2017, the Medical Device Rules were put out by the Indian government to change the way medical devices are regulated. The rules went into effect in January 2018, and the Central Drugs Standard Control Organization (CDSCO), which is part of the Ministry of Health and Family Welfare, is in charge of making sure devices follow the rules. Before 2005, there were no rules about medical devices in India. But today, the Medical Device Rule states that certain types of medical devices have to go through a registration process. Even though the list of regulatory standards is long, the CDSCO sometimes adds new items to it.
Read our Article:CDSCO Medical Devices Manufacturing Registration Requirement