MEDICAL DEVICE REGULATION: SHAPING THE INDUSTRY FOR THE BETTER
No matter what aspect in life, compliance is important. In the healthcare ecosystem, people need medical device regulations to ensure the success of every manufacturer and safety of every consumer. If you fail to achieve compliance, you will compromise the future of your medical technologies.
Today, devices must go through a complex process of regulatory approval. If you want to obtain market entry, you need to seek help from regulatory affairs professionals. They lead the pre-market strategy, handle regulatory submissions, and ensure post-market compliance. They serve as a critical function throughout a medical device’s lifecycle.
Involving regulatory affairs in every aspect of a medical device’s lifecycle is important, especially in a company that seeks to innovate. This article will explain why.
Pre-Market Regulatory Technique
As manufacturers work to bring the concept to reality, the regulatory affairs professionals play a crucial role in advising the team on appropriate regulatory strategies to make sure that they legally place the medical devices on the market.
During the earliest meetings, regulatory affairs medical devices professionals advise you on how various decisions may affect the type of regulatory submission required, including the associated timelines.
If your products will be distributed internationally, the regulatory affairs coordinate with regional teams to ensure the products have a global regulatory strategy. They know and understand the international regulatory requirements your device will be subject to. They ensure that the product development team considers these international requirements as they test and validate the device.
Compliance Ensures Medical Device’s Safety for Patients
Medical devices should be safe. Patients expect medical technologies to improve their health and even save their lives. With medical device compliance, it guarantees patients that the device they are using is safe and effective.
After all, the goal of creating medical devices is to provide effective solutions to healthcare needs. If the device is not safe, you will only risk patients getting hurt.
Compliance Gets Medical Device Approval from Regulatory Bodies
By ensuring a medical device’s safety, it will be easier for you to get approval from the regulatory bodies. Heads up: the medical device industry is deliberately regulated.
The Therapeutic Goods Administration (TGA) oversees the medical device regulation in the country. They set compliance regulations to make sure that your medical devices are safe to use. They emphasise on putting quality products on the market.
It’s true, producing premium quality medical devices is in everyone’s best interest. Registering your products with the TGA entails risk-based medical device classification, compliance with safety, performance, and quality principles, compliance with regulation for manufacturing system, listing in the Australian Register of Therapeutic Goods (ARTG), and the post-market surveillance.
The stakes are high on medical device approval because you’ll face penalties without it. If you stay non-compliant, you will only minimise your medical device’s chance to reach its market.
Compliance Makes Medical Device Audits Run Smoothly
The Therapeutic Goods Administration conducts application audits to conform that medical devices submitted for inclusion in the ARTG meet the relevant requirements.
For an easy and quick audit process, you can hire Vicki Partridge for a pre-audit assessment. She will provide you with advice about the breadth and depth of a full TGA audit. She will also evaluate the quality and quantity of the available information, identify the gap, and recommend remedial action.
The pre-audit assessment service will not only prepare you to meet the requirements of the audit process but will also give you the value of money you spend on expensive audits.
If you have met the compliance regulations and you have a documented traceability matrix, you are ready for an audit. In case you do not pass an audit, you will have to shell out some money to fix the problem. In instances that you receive a warning letter, or your device is recalled, your reputation might suffer.
Regulatory Submissions and Marketing Applications
When you are ready to market medical devices, let the regulatory affairs draft successful marketing submissions. To complete a successful submission, the medical device application must go through an audit process. You will be notified when your application is selected for audit.
The Therapeutic Goods Administration will identify what level of assessment audit is appropriate for your application and the documents you provide, including the assessment fee which depends on the level of assessment.
The time frame for conducting audits depends on several factors, such as the time you take to comply with the requirements, the quality of the information you provide, and the time you take to pay the audit assessment fees. If you fail to comply with any requirements of the TGA with the specified timeframe, the audit will not continue, and your application will lapse. You may withdraw your medical device application before to any decision on whether or not to include the medical device in the ARTG.
Regulatory Affairs will review all product labelling to ensure all claims are consistent with the approved intended use. Your company’s device sales team may use marketing claims to differentiate your products from that of competitors. But if your claims tell about a product that has not been approved, your company will be put to risk of receiving a warning for misbranding.
Therefore, medical device companies need regulatory affairs to ensure all materials associated with any device are appropriate.
Post-Market Vigilance Programs
After the approval of a medical device, companies continue to rely on regulatory affairs. In the post-market setting, regulatory affairs serve as device surveillance. They make sure that adverse events or malfunctions are appropriately reported to the TGA.
Through post-market surveillance reports, companies will be able to identify trends in complaint data and respond to any unintended effect. For instance, if you receive malfunction reports indicating an implanted device is causing unexpected pain after surgery, the pain might be a result of an issue from the device.
The Regulatory Affairs will review the reports and work with the TGA to initiate voluntary recalls to avoid unintended harm to patients.
Key Takeaways
Regulatory Affairs professionals help shape the industry for the better. They protect medical device manufacturers from getting into trouble with the regulating authorities and they serve the needs of the stakeholders by making sure that companies put safe and reliable products to market without any barriers to clearance.
For companies that do not have a regulatory professional, it is important to work with someone who has extensive expertise in the field. Vicki Partridge is here to help you!
Vicki has been with the Therapeutic Goods Administration for more than 15 years and has worked with and interpreted the legislative and regulative requirements for many supplies of therapeutic goods in Australia. With Vicki Partridge, your medical devices are in good hands. Head on over our website and see what we can do to help you.
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