Essential Principles Checklist for Medical Devices Company

All medical device manufacturers are expected to prove compliance with essential principles. These principles provide safety and performance standards for designing and manufacturing medical devices. Furthermore, these principles, guidelines, and standards have been formulated keeping in mind patient safety and outcome. The central drugs standard control organisation (CDSCO) is the apex regulatory body for all medical devices marketed in India. The CDSCO has laid down the essential principles providing guidelines for safety and performance for devices entering the Indian market. Additionally, a checklist has been provided for easy reference to ensure compliance. The essential principles checklist for medical devices is basically a guidance document for manufacturers to prove compliance with essential principles. Manufacturers can refer to this checklist to demonstrate the safety, efficacy, and high quality of the medical devices they manufacture.

We at Pharmadocx Consultants offer essential principles compliance service for medical device companies. Our team of experts provides essential principles checklist documentation support. We have extensive knowledge and expertise in the CDSCO regulations for medical devices. Thus, we will leverage our expertise and leave no stone unturned to help you achieve regulatory compliance. Our team will ensure you can smoothly run your medical device business with no regulatory hiccup.

Parameters that form the basis of essential principles for medical device safety and performance

• The health and safety of patients should not be compromised by using the medical device.
• The medical device should be safe for use throughout its lifetime.
• Benefits of the medical device should outweigh any undesirable or negative effects or potential risks
• Medical devices should not be adversely affected while being transported or stored.
• The manufacturers should furnish sufficient clinical evidence that the device meets the relevant essential principles.
• For medical devices that generate radiation as part of their intended purpose, sufficient protection against radiation should be in place.
• Chemical, physical, and biological properties of physical medical devices should not adversely affect their users. Materials used to construct these physical medical devices should be compatible with the biological tissues of the patients. However, this parameter does not apply to medical devices that are software or virtual anatomical models.
• For medical devices to be used in combination with other equipment or devices, each of them should be compatible with each other. When used in combination, they should be able to operate smoothly and not interfere with each other.
• Medical devices equipped with a measuring function must provide precise, accurate, and stable measurements.
• For medical devices with an internal power supply, they must be fitted with a means of determining the state of the power supply. For medical devices with an external power supply, they must be equipped with an alarm system for indicating power failure.
• A medical device should be designed in a manner that minimises risk of contamination of the device by the patients. Additionally, the device should not pose risk of infection to patients or medical practitioners.
• Construction and design of medical devices must conform with industry safety principles and regulatory guidelines.
• The medical devices must be suitable for their intended purpose and must perform as intended.
• The medical device should be designed in a manner it is easy to handle.

Contact us for hassle-free essential principles checklist compliance and documentation

Essential principles for medical device: General principles

The CDSCO has laid down certain general principles for medical device safety and performance. The essential principles checklist is formulated based on these general principles and certain device-specific principles. We have presented an outline of the general principles. The general essential principles applicable to all medical devices are as follows:

• Medical devices should be designed, constructed, and manufactured in a manner that when used by a knowledgeable person, they will perform as intended. Additionally, they should not compromise the clinical condition or safety of patients or their users.
• Throughout the lifetime of the medical device, as intended by the manufacturer, the device should not adversely affect the safety and health of the patient.
• The manufacturers should plan the design and manufacturing procedure for the devices taking into consideration safety principles. The manufacturers should aim to maximise the reduction of risks associated with the device. Furthermore, if there are any residual risks or hazards associated with the device, they should be justifiable and acceptable. Additionally, users should be made aware of these residual risks.
• All risks associated with the medical device should be acceptable when weighed against benefits to be imparted by the device. Medical device manufacturers should strive to minimise any undesirable effects associated with the device.
• Medical device manufacturers should be able to present sufficient clinical evidence proving the device complies with the essential principles checklist. The clinical evidence prepared should be apt for its intended use and medical device classification.
• The manufacturers should design and package the devices in a manner that the devices can serve their purpose. They should be able to perform as intended by the manufacturer.
• Manufacturers should design, manufacture, and package the devices in a manner that their characteristics and performances are not adversely affected during transportation and storage.

Medical device manufacturers have to demonstrate essential principles compliance using the essential principles checklist. This requires extensive knowledge of the regulatory guidelines and safety and performance standards laid down by the regulatory body. For a medical device manufacturer, it is not possible to stay abreast of the latest regulatory updates. Hence, a regulatory support service can be very helpful to achieve compliance. This is where our regulatory service comes into picture. We provide a comprehensive CDSCO regulatory support.