You have compiled all of the necessary documentation for your regulatory submission, submitted it to the appropriate regulatory body, and received the much-anticipated news that it was accepted.
It’s finally time to start selling your device, right?
Before legally selling your product, you will first need to register your device in the market(s) in which you intend for it to be used.
Early consideration and planning for your medical device registration is a key component of your regulatory strategy. You don’t want to find yourself in the final stages of development when you learn that your product doesn’t meet your target market’s registration requirements.
In this article we'll cover the top global market regulatory frameworks for medical device registrations to lay the foundation for five key pillars that will enable go-to-market success and ensure market sustainability.
medical device registration requirements
Nearly every region around the world has a formalized registration process that medical device facilities must follow to legally sell a product into market, each of which vary slightly from the next.
Not only do you need to register your device initially, but you may need to renew your registration on a recurring, annual basis.
Let’s look at the registration requirements of the top global markets to see how the medical device registration process varies from one region of the world to the next.
Medical device registration | FDA (United States)
All facilities that intend to sell a medical device in the United States marketplace are required by law to register annually with FDA. These requirements are outlined by FDA in 21 CFR Part 807 and must be met by following a two-step process, known as establishment registration.
Here are the two steps medical device establishments must follow, in the order listed, for product registrations and listings:
- Submit payment for an annual registration user fee, and
- Complete the registration and listing process.
The annual establishment registration fees fluctuate year over year, with the following fees to be collected by FDA listed below:
Registration User Fee
Medical device facilities must electronically submit this information to FDA and also receive email notification confirming compliance with all necessary requirements before the full registration process is considered complete.
Most medical device establishments are also required to list any devices that are manufactured at their own facility and provide detailed descriptions of the activities performed on said devices.
If a Class II or Class III device requires premarket approval or notification, respectively, to be sold in the U.S., the premarket submission number (510(k), PMA, PDP, HDE, De Novo) must also be included with the listing.
Medical device registration | MDR / IVDR (Europe)
To lawfully register a medical device in the European Union (EU) marketplace, manufacturers of both medical devices and in vitro diagnostic (IVD) devices must comply with the applicable requirements found in Regulation (EU) 2017/745 and Regulation (EU) 2017/746, respectively.
The MDR will go into effect on 26 May 2021, after a three-year transition and 12-month extension resulting from the impact of COVID-19 on the device industry, with the IVDR planned for 26 May 2022.
Registration under these new regulations will be carried out through the European database on medical devices (EUDAMED). This registration database will collect medical device and IVD registration details and improve the transfer of information for products sold in the EU marketplace.
The EU Commission delayed full implementation and use of EUDAMED until 2022. Until that time, registration will be managed by and according to specific European member states' guidelines in which the device intends to be sold.
Medical device registration | Health Canada
The regulating authority for licensing medical devices in Canada is the Medical Devices Bureau of the Therapeutic Products Directorate, Health Canada.
Manufacturers of Class I medical devices are not required to hold a licence; instead, compliance and enforcement activities of these devices are monitored by Health Canada.
Licensing is required for Class II, III, and IV medical devices in Canada. Manufacturers of these devices must obtain one of two different types of licenses issued by Health Canada.
The two types of medical device licences issued in Canada are:
Health Canada Medical Device Establishment License (MDEL)
Health Canada Medical Device License (MDL)
A Medical Device Establishment License is required for manufacturers of either Class I medical devices or in-vitro diagnostic (IVD) devices. Distributors and importers of all classification types must also obtain a MDEL permitting the importation and distribution of a medical device in Canada. MDEL serves as a permit, whereas a MDL is considered a product approval.
All Class II, III, and IV medical device and IVD device manufacturers must hold a Medical Device License in order to sell into Canada. Obtaining a MDL follows a similar product authorization process to that of FDA’s 510(k) submission process in the U.S. market.
In order to obtain a Medical Device License, manufacturers must first receive ISO 13485 certification through the Medical Device Single Audit Program (MDSAP). Similar to that of FDA in the U.S., Health Canada collects an annual license fee from manufacturers, distributors, and importers of medical devices in Canada.
Medical device registration | TGA (Australia)
In Australia, medical devices and IVDs are regulated by the Therapeutic Goods Administration (TGA). In order for a medical device to be legally exported from, imported into, or supplied for use in the Australian marketplace, inclusion in the Australian Register of Therapeutic Goods (ARTG) is required.
The ARTG serves as the official Register of therapeutic goods that can be lawfully supplied in Australia. Upon consent of the Australian Secretary, a medical device or IVD will be included in the ARTG.
The following information about medical devices can be found in the ARTG online database:
Product name and formulation details
Sponsor/company and manufacturer details
Annual charges and application fees are also collected by TGA, with amounts ranging by device type, class, and other miscellaneous items.
#1. Build business case for registering medical device in target marketS
Companies often neglect spending the necessary time building the business case for the targeted market(s) of their device. Entering a new market should be a strategic business decision made by the company and its trusted industry-based advisors.
A considerable amount of planning should be put into “upstream” activities, such as identifying certain product features that are relevant to a specific region of the world, market size and potential users, and costs associated with bringing the device to market.
For example, some countries may require the Instructions for Use (IFU) to be translated into a specific language, or expect a certain type of barcode to be used for the product label. Early consideration and planning of these specifics will prevent rework and help to avoid unrecoverable costs.
When it comes to assessing market size and other key factors, these two knowledge resources can provide valuable information for building your business case:
CIA.gov - a worldwide “fact book” breaking down demographics and other facts by country. You can even find medical-based information, such as hospital bed density.
Export.gov - an export fact sheet for each country around the world. You can find both export and import requirements for any of your target markets.
By knowing which markets you'd like to sell into early in the process, your team will be able to account and budget for these items when creating its initial project plan.
#2. Organize medical device registration documents
Staying organized is vital for regulatory compliance. All documentation relating to your medical device registration should be organized within a formal quality management system (QMS). This centralized location allows you to easily identify the specific registration requirements for your product to successfully enter the market(s) of your choice.
Investing in quality is important, so it’s just as important to compare the different quality management solutions available. Choosing the best QMS software can streamline document management, reducing administrative tasks and costly rework that can cause significant delays with the registration and licensing process.
Your QMS should contain all essential documentation for your medical device registration, including:
Regulatory certificates, and in some cases
Specific test information.
Along with the initial registration, you need to be vigilant regarding renewal timeframes for all of your in-market devices. With various regulations across the globe, you might even have to juggle your device being classified one way in one market, and a completely different way in another.
Needless to say, if you’re the QA/RA role in charge of your medical device’s registration, it’s your responsibility to ensure all of the necessary steps are taken to enter and remain in market. Organization is key for doing this effectively.
#3. Leverage QMS to meet registration requirements
Compliance with specific registration requirements is a crucial regulatory activity for compliance. The documents you submit during the registration process must be up-to-date and include proof of any market prerequisites that have already been met, such as ISO 13485 certification and other relevant licensing.
You must be able to show objective proof that your documentation has been generated, reviewed, and approved using the quality system you have in place. Consider establishing an executive summary document that lives within your QMS to guide internal and external stakeholders in the right direction for accessing the necessary information at a moment's notice.
Leverage your QMS for quick and timely access to all relevant market authorizations and registration documents, not just for the initial application, but for renewal periods that require it, as well.
You’ll be glad when you have an automated tracking system to remind you of important due dates and reminders so that critical deadlines are met, not missed—a sure fast way to jeopardize the market sustainability of your device.
If you’re using legacy QMS solutions that rely on spreadsheets or task management reminders for your medical device registrations and renewals, you’re assuming significant and unnecessary risk of key deliverables being missed. It’s all too easy for things to get “lost” in those sorts of ad hoc or "digital paper" systems.
#4. Develop long-term registration strategy for target markets
A long-term regulatory strategy for future target markets is the fourth pillar you can implement to ensure a successful outcome for your medical device registrations.
With regard to your documentation, you should have a record of proof for all internal and external decisions for your medical device and justifications for how those decisions were made. Documenting who did what and all parties involved in those communications can also be helpful.
Consider creating work instructions that walk through the steps that were taken during the registration process for the markets you enter. These instructions can include regulatory documents and standards that apply to a specific market.
Greenlight Guru’s MDQMS software makes this an effortless task with this linking functionality built into connected workflows. This is hugely beneficial for teams to avoid recreating the wheel each time you register a new medical device or renew an existing product.
This type of modernized tool builds a critical archive of information within a single source of truth that is secure and easily accessible. You can think of it as insurance for your long-term regulatory strategy with future markets you plan to register your device.
Establishing your long-term market strategy in an accessible manner will help streamline the registration process and reduce risk from both a compliance and business standpoint.
#5. Keep registered medical devices and systems compliant
Global regulatory compliance may feel difficult to ever fully gain a firm grip on, given the ever-changing nature of the regulatory landscape.
Regardless of which market you register your medical device in, one thing is for certain: expectations of regulatory authorities remain the same. You must have the correct documentation in place and show that you’ve successfully completed the registration process before your medical device can gain access into a particular market.
Organizing and maintaining that proof of information in a streamlined, accessible manner is key. Absence of proof may result in regulators drawing conclusions that other noncompliances exist, especially if you're selling into multiple markets.
It’s also important to understand the varying regulations for medical device importation and exportation across countries.
If you don’t meet the necessary importation or exportation requirements of a particular region,
Your product can get stuck in Customs. This can result in long delays with your products being returned if they are rejected. Being able to show proof that you meet the import/export requirements will save you a lot of time and money.
Your company could face penalties and fines for improperly importing or exporting goods. Disciplinary actions can be extremely expensive to remediate, as fines may be assessed based on bulk shipments or individual products.
Early planning and organizing of your key documents, records, and files pertaining to your device registration through a formal document management system is strongly recommended for optimal execution of your regulatory strategy to achieve market access and sustainability.
At the end of the day, a successful medical device registration comes down to strict adherence to regulatory requirements, organization of all relevant documentation, and effective communication between internal and external stakeholders. Leveraging an industry-specific quality system, which is built to enable those processes, is key.
Greenlight Guru is the medical device industry’s only MDQMS software that’s purpose-built to streamline the go-to-market process for easy market entry and sustainability, resulting in faster timelines for better returns on investment, and promotes True Quality every step of the way.
Looking for an all-in-one QMS solution to advance the success of your medical device by integrate total product lifecycle activities? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →