You know what is common in all countries? No matter the geographical position, the culture, the people or religion? No one wants medical devices that are unsafe. Seriously, there is literally not one sane person on earth who would say, “You know what? I don’t really care whether the medical device I am using is safe or not.”
And hence, people, we have regulatory authorities. Almost all countries have them, and they ensure that medical devices people are using are safe for use, among other things. In this article, we will learn about the most prominent global medical device regulations and how they differ from each other.
Why is Regulating Medical Devices important?
So, let’s point out the obvious first. Medical device regulation is there to ensure that all medical devices are safe and effective for their intended purpose and not a threat to public health. So, before any new device is allowed to enter the market, regulatory agencies assess it to ensure that it meets the safety criteria that are put in place by that government.
Another benefit of this is that consumer trust grows when manufacturers demonstrate that their goods are dependable, with very low adverse events, and meet quality standards. The stricter the regulatory requirements are, the more safe the consumer would feel that what they are buying actually works.
Since we are talking about medical devices, there is another factor here. The users of the devices are often healthcare professionals who utilize the device. And they need accuracy. They need to know all the i”s are dotted and the t’s have been struck through. Since a lot of the work they do is also research and innovation, it’s imperative that all devices are vetted beforehand. Regulations also foster innovation in medical device development, improving patient outcomes and safety.
Of course, there is a preventing crime part. Medical Device regulation also prevents counterfeiting or fraud inside the sector. Regulatory bodies can limit the danger of counterfeit items entering global markets by ensuring that quality criteria are met. Most regulatory organizations follow a classification system that allows them to control the regulatory requirements more strictly. There are laws in place to ensure that consumers receive safe and effective medical equipment while manufacturers are held accountable for the items they generate.
Why do YOU need to know about different Global Medical Device Regulatory Authorities?
When you are a manufacturer of medical devices, there are some things you really have to be aware of: the regulatory authorities overseeing your product approval and regulation being one of them.
In most countries, governments regulate medical devices. Each device must receive approval from the local medical device regulator before being marketed. But we already knew that.
Here is something you might not have known. Apart from government regulators, some international organizations also oversee medical device regulations. The International Medical Device Regulators Forum (IMDRF) consists of representatives from Australia, Brazil, Canada, China, the European Union, Japan, and the USA regulatory bodies. Formed in 2011, it plays a significant role in harmonizing international regulations for faster product approvals and market access. The IMDRF also provides guidance on regulatory pathways and clinical evidence requirements.
The IMDRF is actually a continuation of the Global Harmonization Task Force on Medical Devices (GHTF), which used to work on standardizing medical devices’ regulations. It disbanded around 2012 when the IMDRF became operational.
There is also the ISO standards. ISO stands for The International Organization for Standardization (ISO). As the name suggests, this organization sets standards for all kinds of operations, including medical devices. The important ones for you include ISO 13485, ISO 14971, and ISO 9001, among others.
These two are not the only regulatory organizations that count. There is also the WHO, which has quite a bit of influence on what gets approved, although it doesn’t usually interfere.
However, the fact remains that understanding the global regulatory landscape empowers you to navigate the necessary steps for market approval. With proper guidance, you can navigate this complex environment and ensure your medical device undergoes thorough evaluation and receives appropriate approval.
Major Regulatory Authorities of Medical Devices
The FDA and the European Commission’s MDR are the two most well-known regulatory bodies for medical devices. There are, however, countless more regulatory agencies that are equally important. Let us look into these.
On 25 May 2017, the European Union Medical Devices Regulation (MDR) took effect, replacing the previous Medical Device Directive (MDD). Clinical data, adverse event reporting, post-market surveillance, device categorization, and risk management were all subjected to tougher restrictions under the MDR. Its goal is to assure the safety and performance of medical devices while also encouraging innovation and competition in the European healthcare technology industry. Plus, the uniform regulatory process for all also encouraged foreign manufacturers to invest and develop in the EU.
MDR places higher restrictions on high risk devices. The Class II devices and Class III devices require more extensive clinical data to get approved than the lower-risk Class I medical devices. In order to keep things transparent, the EU has also introduced The European Database on Medical Devices (EUDAMED), which has a list of all devices, parts of the clinical data, and other info.
Australia’s medical devices agency is called the Therapeutic Goods Administration. To achieve worldwide standards and harmonization, the TGA has adopted principles outlined by the International Medical Device Regulators Forum. However, it does have several regulations of its own. To get approval for your medical devices to be sold in Australia, you will need a sponsor who will submit all info to the TGA, who will then do a conformity assessment against their essential principles. They also have the class I, II, III, and AIMD classifications.
It’s important to note that many of the Australian medical devices are imported. So is India’s. So, there is a huge market over there for device manufacturers.
In India, the regulatory body is the Central Drugs Standard Control Organization (CDSCO). The CDSCO has adopted a categorization system similar to that used in the United States, classifying items based on their potential harm to patients. Similarly to the EU, the Indian regulatory authorities also enacted stricter import and registration requirements for medical devices and in vitro diagnostics devices.
Another huge market for medical devices is in China. There, the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA), controls medical device regulation. They categorize things depending on their danger and function. Similar to EUDAMED, they also have an Electronic Regulated Product Submission (eRPS) system for medical device registration.