The CDSCO (Central Drugs Standard Control Organization) published an order on April 18, 2021, defining all implanted devices, MRI equipment, & other medical devices as drugs, with an April 1 effective date. The importer or manufacturer of such devices is required to obtain an import or production licence from the Central Licensing Authority under Order No. S.O. 775(E), dated February 8, 2019. All implantable medical devices, including C.T. scans, MRI machines, Defibrillators, PET, Dialysis, X-ray, and bone marrow cell separator equipment, fall under this category. Because of this, if an existing importer or manufacturer of one of the devices listed earlier applies for a licence under the MDR of 2017, the application will be approved, and the importer or manufacturer may continue to import or produce such devices. This article will discuss CDSCO Medical Device Registration for MRI machines.
Brief Introduction to MRI Machine
The non-invasive imaging method known as MRI (Magnetic Resonance Imaging) produces detailed three-dimensional anatomical images. It is based on cutting-edge technology which excites & detects changes in the rotational axis of hydrogen nuclei (protons) in the water, which makes up biological tissues. It is widely used to detect, diagnose, and track disease progression. Powerful magnets are used in MRI to produce a strong magnetic field that forces the body’s protons to align with it. When the patient pulses a radio frequency current, the protons packets are excited and align their axis, forming an equilibrium against the magnetic field’s pull. When the radio frequency field is off, its magnetic vectors return to their resting state, causing energy to be generated in the form of a radio wave, which can be detected by MRI sensors. The molecules’ surroundings and chemical composition impact the amount of energy released, and the time it takes for the protons to realign with a magnetic field and the number of transmitted radio frequencies. Doctors can determine various tissue and abnormalities types based on this magnetic resonance and the lack thereof. To receive an MRI machine, a patient must be placed inside a massive electromagnet magnet and maintain extreme stillness throughout the imaging process to prevent the image from superimposing incorrectly. Before or during the MRI, a patient may receive intravenous contrast agents (usually containing the element gadolinium) to speed up (T1 and T2 relaxation time), which causes the pace at which protons realign with the magnetic field to undergo a change.
Regulatory Bodies for the CDSCO Medical Device Registration in India
- CDSCO is the top regulatory body in India, under the Directorate General of Health Services (DGHS) & Ministry of Health & Family Welfare that regulates drugs & medical devices.
- The Drugs and Cosmetic Act & Rules: These rules regulate the manufacture, import, and distribution of Drugs & medical devices in India.
- DCGI: It is the head of the CDSCO and is responsible for approving quality drugs, medical devices and cosmetics to be sold in India and regulating clinical trials.
Classification of Medical Devices
Medical devices under CDSCO have been classified into two categories, as given below:
- Notified Medical Devices
- As per Rule 4 of medical devices rule 2017, notified medical devices are those whose registration is mandatory.
- Notified medical devices comprise 37 products that must be CDSCO Certified.
- Non-Notified Medical Devices
- As per the new amendment issued by CDSCO, devices such as implants, instruments and apparatus, irrespective of their usage for a distinct purpose, will fall under non-notified medical devices.
- Non-notified medical devices include 313 medical products, which must be CDSCO Certified.
Risk Based Classifications for Medical Devices under CDSCO
The medical devices have been classified into different categories depending on risk type:
|A||Low||Syringes, Surgical dressings, etc.|
|B||Moderate low||Pregnancy kits, Surgical gloves, etc.|
|C||Moderate high||Anaesthesia, Lung Ventilators, etc.|
|D||High||Pacemakers, Heart & Lung Bypass Unit, implants, etc.|
Documents Required to Obtain CDSCO Medical Device Registration for MRI Machine
Following are some vital documents required to obtain CDSCO Medical Device Registration for MRI Machine:
- Form under the proforma prescribed in the Drugs and Cosmetics Rules;
- ISO 13485 Certificate;
- C.E. Design Certificate;
- Legal manufacturer’s name and address with phone no. email id;
- Full Quality Assurance Certificate;
- Actual Site details;
- Undertaking that all the details provided are authentic;
- Nature of activity (import or export)
- Certificate of Marketability through GHTF (the United States, the European Union,
Japan, Australia, Canada)
- Band Name (if registered under the Trade Marks Act, 1999);
- Device Master File;
- Free Sale Certificate (FSC) or/and Certificate from the Foreign Government;
- Plant Master Report.
Process to Obtain CDSCO Medical Device Registration for MRI Machine
- Application form will be duly submitted online in the Sugam portal of the Ministry of Health.
- Submit required essential documents.
- Declaration for compliance with quality management system will be duly submitted.
- Documents scrutinisation will be done through the LA (Licensing Authority).
- If the devices are class B, an inspection will be conducted through the notified body within three months of submitting the application form.
- An inspection report will be submitted to CLA/SLA, and a grant of registration certificate will be provided after scrutinising the reports.
- In the case of the device under classes C & D, inspection will be conducted through competent officials.
Time Taken for CDSCO Medical Device Regulation for MRI Machine
It takes around 6-9 months to register a medical device. Unless an examination is required by the Subject Expert Committee or Technical Presentation, in case these are essential, the registration procedure is extended by an additional 3-6 months.
Renewal of the CDSCO Medical Device Registration for MRI Machine
The application form for renewal of medical device registration shall be made at least nine months before the expiry of the CDSCO registration. Since there are no additional requirements for the renewal procedure, it will be vital for the registration certificate holder to provide a copy of the Device Master File (DMF) and Plant Master File (PMF), where there is no change in the DMF & PMF.
In summary, we can state that CDSCO is consistently working to improve its services’ transparency, accountability, and regularity to guarantee the promptness, safety, potency, and quality of the medical products produced, imported and distributed in India. In conclusion, it is suitable to conclude that CDSCO Registration gives the public interest priority.