Do you want to start your business, so need to know the process of medical device registration across global markets? Or are you new in the world of medical devices and want to gather more knowledge about them? Then this article is perfect for you.
Medical devices are instruments and equipment that we need in the medical field. Some basic examples of medical devices are a syringe, x-ray machines, lasers, etc. There are different classes of medical devices which differ based on risk level.
And hence to ensure safety, countries impose some restrictions and rules while buying or selling them, i.e., registration process. In this regard, this article has provided 5 tips to register medical devices.
Let’s get started!
Medical Device Registration Process in Different Countries
The process of medical device registration differs from country to country and region.
However, it’s essential to register a device in the market before we start selling. Not only do we need to register the device, but we also need to renew the papers every year.
Let’s see how medical device registration works in the US, Canada, and Europe.
United States
In the United States, you need to register the device with the FDA. According to the FDA, Establishment registration is a two-step process.
The two-step process includes:
1. Pay your registration fee
2. Complete your registration.
However, the registration fee of the US slightly changes every year. For example, the cost in 2020 was $5236, but in 2021, it was $5546.
Additionally, you need to register online with the required information. However, you get the reply as an email.
Canada
In Canada, you need to register with the device medical device bureau. There are two types of licenses in Canada, which are:
1. MDEL –
MDEL is a Medical Device Establishment License, and they provide a permit for medical devices.
2. MDL –
MDL is a Medical Device License, and they provide device approval.
All the licenses depend on different classes. However, class I doesn’t require any permission as they are necessities. In Canada, you need permission for class II, III, and IV devices.
Europe
In Europe, you need to register a medical device with IVDR. The European Union uses databases for medical devices.
The database includes:
1. Medical device collection
2. Registration details
3. Price of devices.
Nevertheless, the states follow European guidelines to implement the medical device registration process.
5 Tips for Medical Device Registration
Like every product, medical device registration comes with pros and cons as well. However, people usually search for tips for medical device registration.
The top 5 tips for medical device registration are:
1. Build your business case
2. Organize your documents
3. Maintain your QMS
4. Develop your strategy
5. Register your medical devices
Let’s look more into the tips.
1. Build your business case
Before you move on to the market, you need to have a proper idea of the market. So, it is essential to build your business case before selling the device.
Being a manufacturer, you need to save some time to figure out the features, including market price, size, customers, etc.
In most cases, the handout that customers receive with a product has different languages. It’s a way to get customers from other countries.
You can also hire a team to get help in building your case. The two main sources where you can get help with information are:
- CIA.gov
- Export.gov
2. Organize your documents
Documentation is vital while you register a medical device. Proper documents help you to identify the requirements of medical devices.
People usually value quality over quantity of a device. So, please choose a good QMS system for your business. A QMS system will keep your documents organized, reduce tasks and be profitable.
A QMS system requires different kinds of documents, like descriptions, certificates, device information, etc. Additionally, while you register, you also need to observe renewal timeframes.
So, it depends on you to choose a plan to survive in the industry.
3. Maintain your QMS
While you register for the new device, it is essential to have valid and proper licensing documents. Your documents will help you move on through the following steps quickly.
However, when you need to renew documents, make sure you also update your information in the registration process. Basically, you are making an executive summary for our new medical device.
If you have updated information, it gets easier to maintain a QMS system. A QMS system is an easy task and accessible in a short time. A QMS system will give you a way that provides proper dates and reminders to complete the task.
If you want to rely on a QMS system, it will be a perfect idea for your growing business.
4. Develop your strategy
If you want a booming business, it is necessary to develop a strategy. A long-term plan will help your business to grow in a short period.
It would be best if you made sure to document your decisions as you would require communicating with other teams. So, the documentation will help you plan a better strategy.
There are many tools that you can use for documentation, and they are easily accessible. Therefore, a long-term strategy will help you grow and reduce the risk of your business.
5. Register your medical devices
Once you have all your documents, it will be best if you register your business. A registered company will easily access throughout markets. Worldwide, customs have different requirements, so registering a business is very necessary.
If your device is stuck in customs, you need to show registration papers to get back your devices. Nevertheless, if you fail to show your documents, you won’t get your devices, resulting in a loss.
Final Verdict
To sum up, medical devices are essential throughout the world. If you want the blooming business, you can follow these tips for medical device registration.
You need to have proper documents and meet the requirements that you are applying for. Other than these, it will help you if you use good QMS systems and tools to keep track.
So, stop wondering and follow these tips if you want your medical device to succeed in the industry!