Certifying your medical device is an essential step for ensuring market success. By obtaining certification, you can demonstrate that your device meets safety and performance standards, instilling confidence in potential customers and regulatory bodies.
The certification process can be complex and time-consuming, but it’s critical to ensure that your device is safe and effective.
Shamkris Group is a trusted provider of Medical Device Certifications and Licenses. We understand the importance of ensuring that your medical device meets regulatory requirements and is safe and effective for use in the market.
Shamkris Group is a globally recognized and highly respected Independent Assessment and Certification Body that provides a range of value-added services to businesses worldwide. They are known as one of the best certification bodies in the world due to its reputation for providing high-quality certification services.
Over the years, Shamkris Group has earned the trust of more than 8,000 clients who have relied on them as their Certifying Body for a range of different certifications. This trust is a testament to the group’s commitment to delivering reliable and accurate assessment and certification services to their clients.
Medical Device Certifications ensure that medical devices are safe and effective for use in the market. The certification process involves a review of the device’s design, manufacturing process, labeling, and intended use, and may also require testing. Once certified, the device can be marketed and sold to healthcare providers and patients.
Benefits of Medical Device Certification:
There are different types of Medical Device Certifications based on the region where the device will be sold.
CDSCO Import License is a type of certification required for importing medical devices to India. The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority in India responsible for ensuring the safety, efficacy, and quality of medical devices.
CDSCO Manufacturing License is a type of certification required for manufacturing medical devices in India. The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for ensuring the safety, efficacy, and quality of medical devices in India.
USFDA 510(k) is a type of certification required for medical devices in the United States. The Food and Drug Administration (FDA) regulates medical devices in the US and requires manufacturers to obtain clearance or approval before marketing their devices.
CE marking is a certification mark required for medical devices in the European Union (EU). The CE mark indicates that a medical device complies with the requirements of the European Union Medical Device Regulation (EU MDR) or the In-Vitro Diagnostic Regulation (IVDR), depending on the type of device.
UKCA marking is a new certification mark required for medical devices sold in Great Britain. The UKCA mark indicates that a medical device meets the regulatory requirements set out by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
ISO 13485 is a standard that outlines the requirements for a quality management system for medical device manufacturers. It specifies the processes and procedures that companies need to follow to ensure that their medical devices meet regulatory requirements and are safe and effective for use.
Label study is a type of medical device certification that focuses on ensuring the accuracy and completeness of labeling for a medical device. It involves conducting a review of the device labeling to ensure that it complies with all applicable regulatory requirements and accurately reflects the device's intended use, indications for use, and potential risks.
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The application process for medical device certifications varies depending on the type of certification and the regulatory body responsible for the certification. However, there are some general steps that typically apply to most certifications:
Determine the appropriate certification: Identify the regulatory body responsible for the certification and determine the appropriate certification for your medical device based on its intended use and classification.
Prepare documentation: Compile all necessary documentation, including design specifications, manufacturing processes, labeling, and testing data. The documentation should demonstrate that the device meets all relevant standards and regulations.
Submit application: Submit the application and all necessary documentation to the regulatory body. Some certifications may require a pre-submission meeting to discuss the application and ensure that all requirements are met.
Review process: The regulatory body will review the application and documentation to ensure that the device meets all relevant standards and regulations. The review process may include testing or inspections.
Certification decision: Once the review process is complete, the regulatory body will make a certification decision. If the device is certified, it can be marketed and sold in the applicable market. If the device is not certified, the regulatory body may provide feedback and suggest changes that need to be made before reapplying.
A medical device certification is a process in which a regulatory body evaluates a medical device to ensure that it is safe and effective for its intended use.
Medical devices need to be certified to ensure the safety and effectiveness of the device for its intended use. Certification also helps to protect patients and healthcare providers from potential risks associated with using medical devices.
Some of the different types of medical device certifications include the CDSCO import and manufacturing license, USFDA 510(k), CE marking, UKCA marking, label study, and ISO 13485.
The time it takes to obtain a medical device certification can vary depending on the type of certification and the regulatory body involved. It can take several months to a few years to complete the certification process.
The costs associated with obtaining a medical device certification can vary depending on the type of certification and the regulatory body involved. It can be a significant investment for medical device manufacturers, including fees for application, testing, and evaluation.
No, a medical device cannot be marketed without a certification. It is illegal to sell medical devices that do not meet regulatory requirements.
No, a medical device certification cannot be transferred between countries. Medical device manufacturers must obtain certification from the regulatory body in each country where they plan to sell the device.