7 Medical Devices Regulatory Restrictions You Need to Know for the Global Market

How Translation Services Can Help Medical Device Regulatory Approvals

Medical Devices Regulatory

It’s every business’s dream of becoming a global franchise. The medical equipment industry is no different. But all that fame comes with some drawbacks. One of the biggest downsides is having to negotiate the changing markets of the world. Every country has its own laws and ethical standards, and sometimes this can get in the way of business. Because of this, there are some restrictions you need to know. We’ll go into some of these various medical devices’ regulatory restrictions below.

1. ISO 13485 Changes

Medical devices regulatory restrictions describe a very long and complicated list of rules that can’t be completely covered in one article. A few restrictions seem especially noteworthy right now.

One of these restrictions is ISO 13485. They updated in 2016 to expand on the concept of risk management. The most noteworthy changes state that risk needs to considered at most functions of the business beyond the creation of the product.

ISO 9001 added risk based thinking to its 2015 standard. So translation service providers that adhere to ISO 9001:2015 standards are in a good place to adequately cater to the recent medical device regulations change.

2. Standards of the European Union

Like most trade and economic organizations, the European Union (EU) has its own set of regulations and standards about various trade goods. Currently, the EU is going through its own set of rule changes concerning what counts as a medical device.

Before 2017, the EU  defined a medical device as a necessary piece of equipment. They have amended these standards to include certain cosmetic and diagnostic devices. This is to enhance the quality of life of those with certain medical conditions and to aid in early detection of others.

Most of the other changes to this policy involve the greater regulation of devices. This is so that companies can more reliably manufacture, track and manage to reduce risks.

You can find a lot of this by doing research on the EU, but just in case you’re not fluent in most of the languages Europeans use, and most of us aren’t, you may want to learn about medical document translation relating to medical devices.

3. 21 CFR Part 807 On Establishments

Another organization with its own set of rules and regulations is the American Food and Drug Administration, or FDA. Regardless of what country you operate in, if you plan to make or sell your product within the United States, you need to register the business with the FDA.

You must also pay a fee and have your information reviewed every year.

Most of these same standards hold true for all medical devices within the United States, even if you’re not yet making or selling them there.

4. 510k

The FDA set 510k as another standard. It concerns the concept of a premarket review. The FDA collects a payment to review the proposed device.

In particular, this refers to Class III devices. Class III is a device whose risks are substantial. The FDA does not require those with less serious risks to go through these reviews.

Under certain circumstances, a company may conduct medical research to determine whether or not the device provides enough medical benefit for approval. We should note that this research must also meet with FDA approval.

5. 21 CFR

This FDA regulation has to do with the circumstances of the device’s manufacture to ensure that no errors occur and significantly harm customers. If some error goes unnoticed and a customer dies or suffers a serious injury as a result, the company must report it to the FDA. You can do that with a failure analysis letter.

The letter helps determine if there are any errors in the device and if the company can fix them. This helps to make the device safer and possibly prevent any further damage.

Other countries where you sell your devices may require that you report these errors to them as well. This often requires the translation of the failure analysis letters into the required languages for these countries.

6. The WHO on In Vitro Diagnostic Devices

The World Health Organization (WHO) faces many obstacles in its quest to rid the world of debilitating diseases. One such obstacle is the high infant mortality rate in various parts of the world.

There are many solutions that the WHO and other organizations are pursuing. One of them is the diagnosis and treatment of dangerous medical conditions in utero (before birth). 

Their website mentions three particular diseases by name: AIDS, tuberculosis, and malaria. These diseases, if found and treated or prevented, would reduce infant mortality, and the mortality rate of mothers.

The WHO relies significantly on professional medical translation services into third world country languages to promote its work and maximize its effectiveness. 

7. Vaccine Safety Regulations

These days, there are a bunch of alarmists out there claiming that vaccines are dangerous. They also claim that those who provide them are corrupt and greedy. One major hole in this “theory” is that two of the major vaccine suppliers are the World Health Organization and the Bill and Melinda Gates Foundation. Both are non-profit organizations.

The WHO, in particular, goes through a rigorous process to ensure vaccine safety. This effort seems to have paid off quite substantially. 

In most vaccines, the risk of severe side effects are often one per hundreds of thousands. The most common issues occur in 5% or fewer of people who received the vaccine.

On those occasions when a vaccine has been found to have a higher-than-preferable risk for medical reactions, they studied, recalled, and re-engineered it to help reduce those risks.

Vaccination benefits don’t recognize borders. Medical translation services are ensuring that the whole world is educated and benefits from their value.

Medical Device Regulatory Standards

Any global business out there is going to have to meet certain standards, and this is especially true with the medical business. There are a whole host of different medical device regulatory standards that you’ll encounter around the world. 

These regulations may range from guidelines for one specific country, such as those of the FDA to international guidelines, like those of the WHO. We’ve mentioned only a few of the many different standards out there. We encourage you to do more research if you’re interested.

But keeping up with all of them is a major undertaking that no one company should be burdened with.

If you want to learn more about the challenges that Medical Device manufacturers and Pharma companies face while getting their products approved around the world, download the below whitepaper. You can also read more posts here. Finally, you can contact us for any additional information. 


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