#CDSCO Registration for MRI Scan

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The Indian MRI equipment market has 290 units and a volume of Rs. 1778.5 crore in 2019; it is anticipated to expand further in the coming years. The market for medical devices in India is anticipated to rise as a result of more new product launches and technical developments. A CDSCO medical device registration for MRI Scan machine is required because an MRI scanner falls into the Class II (moderate risk) category of medical equipment.

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Central Drugs Standard Control Organisation is, known as CDSCO, is a regulatory body for the Indian medical devices industry, under the vittles of the Drugs & Cosmetics Rules, 1945 and Drugs & Cosmetics Act, 1940 and it’s the national regulatory body for Indian pharmaceutical and medical devices. Team Operon Strategist will help you in CDSCO Registration or DCGI approval for your products as per the guidelines of CDSCO.

Medical Devices entering to India must be in compliance with the Indian Medical Device Regulation set forth by the CDSCO. The CDSCO is responsible for the approval and regulation of New medicines and Clinical Trials in the Country, laying down the norms for medicines, control over the quality of imported drugs, collaboration of the activity of State Drug Control Organizations.

As per the new Guidance of CDSCO, suspense and cancellation of the Class A & B medical devices may be if importer fails to meet the deadline specified by CDSCO. CDSCO has set a complete procedure for granting license for medical devices imported in the country. This procedure is applicable when we import medical devices from other countries to India. still, they need to be classified according to CDSCO notified devices list, before manufacturer were suitable to sell their medical device in India without following any specific rules and regulations but from 2006, medical devices entering to India need to follow specific guidelines set by CDSCO. 

How Operon Strategist Will Help You in CDSCO Import License?

Operon strategist is the leading medical device regulatory consulting company. We help our guests in making specialized dossier for the licensing process, we also solve the queries raised by the regulators, and we're delivering turnkey services, system implementation, training, licensing, regulatory approvals and certificates.

CDSCO issues Medical devices importing license under the Directorate General of Health Services in the Ministry of Health & Family Welfare. Speed up your import licensing process with us; Operon Strategist will assist you at every step of medical device importing license.

ALL IMPLANTABLE DEVICES, MRI AND CT SCAN EQUIPMENT NOW REQUIRE IMPORT LICENSES 

With the release ofF.No. 29/ Misc/ 03/ 2021- DC( 28) on April 18th, 2021 the Central Drugs Standard Control Organization( CDSCO) now requires the following medical devices gain an Import License previous to importation.

All Implantable Medical Devices 

CT Scan Equipment 

MRI Equipment 

Defibrillators 

PET Equipment 

Dialysis Machines 

X-Ray Machines 

Bone Marrow Cell Separators 

CLASSIFICATION OF MEDICAL DEVICES 

The medical devices are classified into the following 4 orders based on the risk involved in operation 

Class A – low risk 

Class B – low to moderate risk 

Class C – moderate to high risk 

Class D – high risk 

The devices are further classified into Surgical andNon-Surgical based on their invasiveness.

NOTIFIED BODIES 

Notified Bodies are Government accredited third- party authorities that are certified by the central licensing authority to review medical devices and check manufacturing spots to insure that they're conforming to the Quality Management System and other applicable protocols specified by the Bureau of Indian Standards. 

GUIDELINES FOR IMPORT AND MANUFACTURE OF MEDICAL DEVICES 

The Ministry of Health andF.W. under Gazette notificationS.O. 1468( E) dated6/10/2005 declared the following sterile devices to be considered as drugs under Section 3( b)( iv) of the Act. 

Cardiac Stents. 

Drug Eluting Stents. 

Catheters. 

Intra Ocular Lenses. 

Cannulae. 

Bone Cements. 

Heart Valves. 

Scalp Vein Set. 

Orthopedic Implants. 

Internal Prosthetic replacements. 

It was also notified vide GSR 627( E) dated7/10/2005 that control over manufacture of these devices would be exercised by CLAA i.e. DCG( I) under the said Rules.

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Government Classifies Medical Devices As Drugs To Improve Quality And Price Control

In a notification released on 11th February, 2020, the Central Government in consultation with the Drugs Technical Advisory Board(DTAB) classified medical devices as drugs w.e.f 1st April, 2020.

The definition of devices to be classified as drugs covers all existing medical devices being sold in the market, ranging from disposable syringes to MRI and CT Scan equipment.

Prior to this notification, only 23 medical devices were classified as drugs and were required to undergo the deliberate registration and analysis procedure.

The devices shall also be registered in CDSCO's online registration system from now. However, using the online registration system will be voluntary for a period of 18 months and mandatory thereafter.

What’s Good?

While the drug license registration process is a very detailed and comprehensive application procedure, involving months of careful analysis, trials and approvals. Medical devices(mainly low and medium risk) enjoyed a more lenient process of registration and control.

Devices such as disposable syringes, disinfectants, surgical gloves classified as Class A or B were either not required to obtain a registration or the regulation was not very strict. This often resulted in sub-standard and forfeited products on the market which lacked quality and were probable of causing harm to the safety of the user.

Bringing medical devices under the category of drugs will ensure that better and high quality manufacturing procedures are followed. Resulting in more refined and better quality products being sold in the market.

This would also prevent duplicacy of products and will offer manufacturers a healthy and competitive market.

What’s Bad?

Classifying medical devices as drugs will result in more stringent approval and inspection procedures. That may greatly affect small and medium businesses manufacturing low risk Class A or B devices like masks or gloves. Not every manufacturer can bear the expenses of the drug licensing process. Especially if he/she manufactures multiple devices.

Important Considerations

Even being a groundbreaking event, this reclassification is neither unexpected nor immediate. The authorities have been pondering over this matter for more than an year and have outlooked every possible aspect.

These new rules are not immediate in effect. Since Class A&B medical devices have been exempted from compliance for a period of 30 months from 1st April, 2020. Whereas Class C & D devices have been provided relaxation for a period of 42 months.

India is the fourth largest medical device market in Asia. While the sale of medical devices covers 30% of the total Indian pharma market.

With that said, this reclassification will ensure that the quality of medical devices sold in India is up to the mark and comparable to global standards.

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Medical Devices to boost ‘Make in India’ for the world | Apollo Telehealth

In a move considered long overdue, the government has initiated a major regulatory reform of the medical devices sector, notifying that all devices, equipment, and even software intended for medical use will now be treated as “drugs” for purposes of regulation and quality control. All devices for sale in India, whether manufactured locally or imported, will now require online registration with the Central Licensing Authority under the Central Drugs Standard Control Organization (CDSCO), the apex drug regulator in the country. Such registration is voluntary for a period of 18 months, after which it will be mandatory. With the inclusion of new published rules in 2020 under Drug and Cosmetics Act 1940, “Medical Device Amendment rules” comes into picture. With this, the manufacturer/ importer has to undergo a stringent set of steps like uploading all the details related to product, certificate of compliance with respect to ISO 13485, clinical validation/accuracy certificate, showcasing free sale certificate from the country of origin, etc. The landmark reform promises to redefine the medical devices sector in India by ushering in an era of better-quality control and boosting safety and regulation standards within the local manufacturing sector.  It will also ensure that foreign companies do not market sub-standard products in India.

The regulatory reform comes at a time when the medical devices sector is poised for major growth. The Indian medical devices market is the fourth largest in Asia and is expected to grow to USD 50 billion in size by 2025. The sector includes a wide array of devices, medical equipment, patient aids, remote care technology, diagnostic equipment, and implants. However, in the absence of a supervising regulatory authority, the sector stood largely unregulated. A study conducted by Anna University in Tamil Nadu threw up shocking facts last year. It found that just one in five ventilators in hospitals across the state had been certified safe by biomedical engineers, resulting in a large number of life-saving equipment short of credibility.

Indian importers, medical fraternity as well as consumers relied largely on foreign regulations like FDA, CE approvals for quality assurance. In the face of rapid growth and proliferation of devices, regulation standards must be strengthened and harmonized with international standards.

The need for better safety and quality assurance

This move has been a long time in the making. Last year, the Drugs Technical Advisory Board (DTAB) had recommended that all medical devices should be notified as “drugs” under the drug regulation law to ensure they maintain safety and quality standards. The government then made it mandatory for all medical devices — manufactured locally or imported – to get notified and get a CDSCO certification. 

The series of developments have come after intense debate and discussion over the need for better quality assurance for Indian consumers for a long time. India’s medical devices sector is heavily dependent on imports, with almost 70% of the demand for devices met by imports. Many of these imported equipment and devices do carry regulatory certificates in other countries, but many countries do not regulate their exports. This lack of regulation might allow certain manufacturers to take advantage of the loopholes and float low-grade devices and equipment in the market, which is a major worry for Indian healthcare. This is why regulating imports becomes extremely important to ensure quality and safety. The new amendment assures– that every medical device, either manufactured in India or imported, will have to have quality assurance before they can be sold anywhere in India.

Boost for local manufacturing

While the potential of the medical devices sector was duly acknowledged with its inclusion in the ‘Make in India’ initiative, several problems continue to hamper indigenous manufacturing and export potential. The absence of a concrete regulatory framework specific to medical devices was a leading factor that constrained investments in the market. Investors are discouraged by the lack of a concrete regulatory and legal framework to govern the sector. As mentioned above, almost 70% of the demand for medical devices in India is still met by imports. Hopefully, the introduction of the regulatory reform will change this. Apart from bringing radical improvements in standards of quality, safety and effectiveness in medical devices, the move will also act as a boost for the local manufacturing sector. The need for instituting strong quality controls will push manufacturers towards better compliance while gradually ensuring harmonizing of quality control protocols with international standards. Better regulatory mechanisms will, therefore, help Indian manufacturers produce globally competitive devices and equipment that are fitter for exports. In a nutshell, the harmonization of India’s regulatory structure with global norms will enable Indian manufacturers to ‘Make in India’ for the world. On a parallel note, a concrete regulatory framework will also boost investments, including from foreign players in the sector, and thereby help in reducing the gap between technology and research in India.

Need for building appropriate expertise

While the reform is much needed, it brings with it a major requirement of bolstering competency and auditory expertise. As regulatory standards become more stringent, regulatory bodies would require more specialized auditors and technical inspectors. On the other hand, all manufacturers – big or small – will also need to institute strong quality control checks internally. This will create major demand for competent bio-medical engineers, lab technicians, doctors and pharma experts to work closely with device manufacturers. This capacity building is an area that needs to be worked upon diligently to make the regulatory reform a success.

With the CDSCO also required to take up the regulatory role for devices along with drugs, it is also essential for the body to ensure it has the necessary capacity and expertise to conduct the process seamlessly. Greater investment in capacity building, skill enhancement, and recruitment of specialized auditors will be needed on a major scale. This comprehensive reform will benefit not only the medical devices sector but also the healthcare service consumer at large. 

Need for separate regulatory bodies

Medical devices and equipment today are used for a wide variety of medical purposes. From diagnostic uses such as CT scan, MRI to Telehealth software platforms used for providing remote consultations, the use of medical equipment is widespread and versatile. The emergence of telemedicine as a major element in furthering the goals of Universal Healthcare has driven the production of devices, software, and equipment dedicated to improving telemedicine experience. Manufacturers are continually working to develop reliable devices and equipment to be able to deliver quality medical images and precision patient data, even from remote terrains. This calls for a broader rethinking of the regulatory approach. While the introduction of the regulatory process is highly welcome, it is imperative that as a country, we gradually move towards separate regulatory regimes for drugs and devices. Devices being engineering products cannot and must not be treated as drugs, and the government must take these efforts to the next level by establishing a separate body for regulating devices, equipment, and technology used for medical purposes.

The industry has so far reacted positively with the new move, though doubts remain about the ability of the Central Drugs and Standards Control Organisation (CDSCO) to effectively regulate both drugs and medical devices. The Govt needs to play a crucial role in making this new move implement successfully by helping provide certifying labs, manpower, technical & clinical assistance as way ahead for Quality Healthcare

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