how to obtain Medical Device Licsence
You’ve assembled all the paperwork required for your regulatory application, sent it to the proper regulatory authority, and gotten the anxiously awaited response of clearance.
It’s finally time to start selling your medical devices, right?
Unfortunately wrong!
To sell your product lawfully, you must first register the medical
device in the market or markets where you plan to sell it
When you know your product won’t be able to register in your target market, you don’t want to be in the last stages of development (s).
The finest regulatory frameworks for the worldwide market for medical device registrations will be discussed in this article, laying the groundwork for five crucial pillars that will help you gain market access and guarantee sustainability.
Medical device registration requirements
Almost every region around the world has a formal registration process that medical device companies must follow to legally sell a product on the market, each one being slightly different.
Not only do you need to register your device initially, but you may need to renew your registration on a recurring yearly basis.
Let’s take a look at the registration requirements for the most important global markets to see how the medical device registration process differs from one region to another around the world.
Medical Device Registration | FDA – USA
All facilities intending to sell a medical device in the US market are required by law to register annually with the Food and Drug Administration.
These requirements are set out by the FDA at 21 CFR Part 807, and must be met by following a two-step process known as enterprise registration, namely:
Send annual registration fee payments to the user.
Complete the registration and listing process.
Medical device companies must submit this information electronically to the FDA and also receive an email notification confirming compliance with all necessary requirements before the registration process is considered complete.
Most medical device companies are also required to list any devices that were manufactured in private facilities, with a detailed description of the activities performed on said devices.
If the device is in Class II or Class III, it requires pre-marketing approval or notification, respectively, to be sold in the United States.
The pre-market filing number (510(k), PMA, PDP, HDE, De Novo) must also be included in the list.
Medical Device Registration | MDR/IVDR (Europe)
To legally register a medical device on the EU market, manufacturers of both medical devices and in vitro diagnostic (IVD) devices must comply with the applicable requirements of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 respectively.
Registration under these regulations will be done through the European Medical Device Database (EUDAMED).
This registration database will collect details of medical devices and IVD registration and improve information transfer for products sold on the EU market.
Medical Device Registration | Health Canada
The regulatory authority for licensing medical devices in Canada is the Office of Medical Devices of the Therapeutic Products Directorate, Health Canada.
Class I medical device manufacturers are not required to obtain a license; Instead, the 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, namely:
Health Canada Medical Device Incorporation License (MDEL)-
Health Canada Medical Device License (MDL)-
A medical device construction license is also required for manufacturers of Class I medical devices or in vitro diagnostic devices (IVD).
Distributors and importers of all classification types are also required to obtain an MDEL that allows the import and distribution of a medical device in Canada.
MDEL is considered an authorization, while MDL is considered an endorsement of a product.
All manufacturers of medical devices and Class II, III, and IV IVD devices must also hold a medical device license to sell in Canada.
Obtaining an MDL follows a product authorization process similar to that for FDA 510(k) filing in the US market.
In order to obtain a medical device license, manufacturers must first obtain ISO 13485 certification through the Medical Device Individual Audit Program (MDSAP).
Similar to the Food and Drug Administration in the United States, Health Canada collects annual licensing fees from manufacturers, distributors, and importers of medical devices in Canada.
Medical Device Registration | TGA (Australia)
In Australia, medical devices and IVD devices are regulated by the Therapeutic Goods Administration (TGA).
In order for a medical device to be legally exported from, imported or made available for use on the Australian market, it must be included in the Australian Register of Therapeutic Goods (ARTG).
ARTG is the official registry of therapeutic goods that can be legally supplied in Australia.
Upon approval by the Australian Minister, 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 formula details-
Sponsor/company and manufacturer details-
Annual fees and application fees are also collected by the TGA, in amounts that vary by device type, class, and other miscellaneous items.