Things You Should Know About Medical Device Registration

The Medical Devices Rules, 2017, has laid down the standards for medical devices being manufactured and imported in India. Devices exported from foreign countries such as France, China, USA, Japan, Canada, KSA, European Union, etc, are required to obtain valid approval and quality clearance certificates under their respective laws and regulations. The Medical Devices Rules mandate that the devices imported into India must undergo requisite clinical investigations and have to procure an intended use certificate. The CDSCO guidelines for medical devices ensure that the devices manufactured or imported in India comply with internationally accepted standards of safety and quality control.

Classification of Medical Devices

For the Purpose of Medical Device Registration in India, CDSCO has categorized medical devices in India into categories based on the type and the risk factor for the medical device. At present, there are about 22 notified medical devices under the Drugs and Cosmetics Act, 1940 and 1945 Rules that require Medical Device Registration with the CDSCO.   The various types of devices based on the type of equipment and nature of use are –

1. Diagnostic and Imaging devices – X-ray, MRI, CT Scanner etc.
2. Injectables and consumables – Syringe, Needles, Drips, etc
3. Dental Products – Braces, tooth caps, crowns, dentures
4. Prosthetics – Crutches, artificial implants, arms, knee implants, artificial joints
5.  Patient Aids – hearing aids, pacemakers, eye lenses, etc.

Furthermore, the Medical Device Rules, 2017, have devised a calculation of medical devices based on risk factors in harmony with international standards and the framework constructed by the Global Harmonization Task Force (GHTF). The four types of devices categorized on risk factors are –

Category A Devices 

These devices signify Low-risk factors. The Medical Device Rules, 2017, have put six devices on this list. Examples of category A devices are Nasopharyngeal Catheters, Disposable Perfusion sets, surgical dressings, umbilical occlusion devices, bolster sutures and alcohol swabs.

Category B Devices 

 These devices signify low to moderate risk factors as compared to Category B devices. With a total of 147 devices in this category, it has the maximum number of medical devices as per Medical Devices Rules, 2017. It contains sub-classifications of major medical apparatuses, such as catheters, disposable hypodermic syringes, IV cannulae, orthopaedic implants, scalp vein sets, and surgical dressings.

Category C Devices

These devices fall in the moderate to high-risk category. There are 125 devices in this category.

Category D Devices

These devices fall in the high-risk category since they are high-precision medical devices such as heart valves, drug-eluting stunts, contraceptives, ablation devices, etc. A total of 72 devices fall into this category.

Regulatory Authorities for Medical Device Registration in India

The Central Government has entrusted the process of Medical Device Registration and Regulation to the Central Drug Standard Control Organization. Additionally, the State Drug Standard Control Organization (SDSCO) administers and overlooks the same within states and union territories. The CDSCO authorities have created separate licensing authorities, both at central and state levels, to oversee the licensing procedure of these domains. They are –

The Central Licensing Authority (CLA) shall have control over the manufacture and import of Class C and D medical devices. Additionally, it will oversee and manage the importation of all medical equipment belonging to the A, B, C, and D classes. All new medical devices and in-vitro diagnostic device (IVD) licenses will be approved after a clinical efficacy assessment and clearance test. It will supervise clinical studies and grant approvals for any medical equipment utilized in research.   

The State Licensing Authority (SLA) will be in charge of overseeing the production and distribution of Class A and B medical devices. It will supervise the distribution and sale of all four classes’ worth of equipment.

Benefits of Medical Device Registration

Medical Device Registration holds a lot of benefits for businesses that manufacture or import medical device registration. They are –

Ensures compliance with regulatory standards

Medical Device Registration and CDSCO License ensure that the medical devices are produced and manufactured as per the statutory laws and guidelines. Compliance with the Drugs and Cosmetics Act, 1940, Rules 1945, and the Medical Devices Rules, 2017, is absolutely necessary since it concerns the safety of patients. 

Opens opportunities for Import and Export

Medical device registration as per the ISSN Standards ensures that the device complies with international quality standards, hence increasing its reliability in the international market. ISO mark and certification make the medical device eligible to be sold in the international market.

Ensures User Safety

Medical Device registration is crucial for a certain number of high–risk–category devices. Since they carry a risk of injury or contamination if used improperly, it is extremely important they are quality-checked to perfection to eliminate any possibility of medical injury to the patient.

Process of Medical Device Registration

The process of Medical Device Registration in India is governed by the Medical Device Rules, 2017, in consonance with the Drugs and Cosmetics Act, 1945 and Rules, 1940. In order to proceed with medical device registration, the manufacturer, producer, or distributor must first ensure compliance with the laws and regulations and proceed with the following process –

Determine the Type of Medical Device License

In order to proceed with the medical device registration, the entity must first ascertain the type of medical device for which the license is sought. There are a total of 22 notified medical devices under the Central Drugs and Cosmetics Act of 1945. Devices such as syringes, catheters, surgical implants and stents, endotracheal tubes, etc, are required to undergo a registration process with the CDSCO. After determining the class in which the medical device falls – A, B, C, D, the applicant shall proceed with submitting documents to the licensing authority.

Filing of Application and necessary documentation

Prior to filling out the appropriate Forms and submitting the requisite documentation to comply with the CDSCO Regulatory guidelines. Based on the nature and type of activity of the applicant, they are required to submit different forms, for example – an application for a license to procure medical devices in Classes A and B shall be made in Form MD- 3, whereas for Category C and D should be in Form MD-7. Apart from the st6atutroy forms, other ancillary documents such as Information about the manufacturing unit and applicant, specification of the medical devise manufactured, chemical composition and formulation method, details of the manufacturing unit, and relevant disclosures are required to be submitted along with the license fees and the fee for inspection of the manufacturing site.

Inspection of the Application

Post submission of the application for Medical Device Registration, the same is examined and scrutinized by the CDSCO Officials and Drug Inspectors authorized by the Department of Drug Control. The officials conduct a joint inspection of the manufacturing site and create a compliance checklist. After inspection, they submit their report to the licensing authority for further evaluation. 

Grant of CDSCO License

Upon satisfactory verification of the required documents and data by the relevant licensing body, the CDSCO registration for cosmetics, in vitro diagnostics, and medical devices is obtained.

If the CDSCO License fee is paid in accordance with the Second Schedule of the Medical Devices Rules, 2017. Once a license is issued, it remains valid for a period of five years; a license, loan license issued under Form MD-5, MD-6, Form MD-9, MD-10, or import license issued under Form MD-15 will remain valid indefinitely. However, a license can be suspended or cancelled by the State or Central Licensing Authorities under any exceptional circumstances.

The CDSCO medical devices license holder will be subject to an additional late payment fee equal to 2% of the licensing fee per month or pay a portion of the license fee if they fail to pay the requisite amount by the deadline.

Documents required for Medical Device Registration

To make a medical device registration in India, the applicant must submit the following documents to the regulatory authority, along with the application form –

• Form 40
• ISO 13485 Certification from the Bureau of Indian Standards
• Power of Attorney and Declaration of Facts
• Certificate of Quality Check
• The lease agreement of ownership proof of the manufacturing premises
• Post Market Surveillance (PMS) Report
• Master File of the Plant
• Free sale Certificate
• Statutory forms – MD -4, MD-5, MD-6, MD- 9 etc.

Medical Devices Policy, 2023

In an attempt to streamline the medical device registration process, reduce dependency on import, and boost domestic production of Medical Devices and apparatuses, The Government of India rolled out the Medical Devices Policy, 2023. The policy aims at achieving a 10-12% share in the global market for medical devices over the next 25 years. Furthermore, the policy aims to provide universal access, affordability, research, and innovation to high-end medical devices such as CT scans, NRI, catheters, orthopaedic implants, valve tubes, etc. The key highlights of the policy are –

Streamlining with Regulatory Framework

The Policy endeavours to make a single widow Clearance System for the licensing and registration of medical devices. In order to maximize the safety and quality of medical devices, the policy discusses gradually enhancing the role of Indian Standards like BIS and harmonizing them with international standards. It also calls for the creation of a cogent and uniform pricing regulation to preserve patient protection and affordability.

Creating Congenial Infrastructure

The policy aims to establish clusters of laboratories, testing centres, quality check centres, warehouses, and manufacturing units, which would enable better interaction of medical device infrastructure with ancillary industries. The goal of the policy is to improve infrastructure and connection, build more medical device parks and similar clusters, especially close to economic zones, and make it easier for the medical device ancillary industry to merge and integrate backwards.

Development of Human Resources

The Medical Devices Policy looks to guarantee a consistent supply of talented workers, including scientists, technicians, regulators, and health experts, throughout the innovation value chain. This covers professional skill development, reskilling, and upskilling in the medical device industry, as well as professional certification; skill development activities and courses are integrated with the National Skill Qualification Framework and the Skill India Portal, respectively.

Ease of Investment and Marketability

The Medical Policy aims to promote Public-Private Partnerships (PPP), venture capital funding, and private investments. In accordance with the policy, this can be accomplished by actively engaging in outreach initiatives like asking venture capitalists to evaluate and support start-ups for incubation, as well as by supporting novel financing methods like blended finance, which combines public and private funding. Further, the policy aims to complement national skill-building and entrepreneurship initiatives such as Make-In India and Aatmanirbhar Bharat, which would give impetus to small enterprises and businesses that engage in medical Device manufacturing and import.

Conclusion

The Central Drugs Standard Control Organization is the key body responsible for Medical Device Registration in India. It oversees the manufacturing and import of medical devices. Furthermore, CDSCO is also responsible for the regulation and administration of the Central Licensing Authority and State Licensing Authority in India, which award licenses for Category A & B and C & D Medical Devices, respectively. Medical device registration in India is a crucial step that allows manufacturers and importers of medical devices to ensure that their products are safe to use as well as qualitative as per medical laws and regulations in India. Non-compliance with the licensing requirements can lead to serious repercussions for the manufacturers since it involves crucial, life-saving medical devices and paraphernalia. Therefore, it goes without saying that any fallacy or mistake in the application process can lead to the cancellation of the Medical Device registration process.

If you are looking to set up a medical device manufacturing business or import the same from foreign nations, medical Device registration is a necessary Compliance. We at Coprbiz provide end-to-end solutions to Medical Device Registration at reasonable price quotes. To know more about our services, contact us today.

Frequently Asked Questions (FAQs)

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