by OMC Medical | Jan 19, 2023 | FDA, Canada, USA
eSTAR (electronic Submission Template and Resource) is an initiative launched by the US Food and Drug Administration in February 2020. It is a free, interactive PDF Form that provides assistance to the applicants in preparing the CDRH medical device submission for 510(k)s and De Novos.
The content of the form is automated with an automatic verification feature, and the structure is complementary to the internal review and also harmonized with the IMDRF and guided construction for each submission section.
The US FDA has announced a pilot program in collaboration with Health Canada. The practicability of using eSTAR will be determined by the outcome of 9 participants. The pilot program has eligibility criteria as below:
- Sponsorer must be in-process to submit an eSTAR application for the same medical device in Health Canada and US FDA within 6 months of acceptance into the pilot.
- The submission must be for a new or significant change amendment to Class III or IV submission of Health Canada OR
- A 510(k), De Novo or Pre-market Approval (PMA) original, 180-day, real-time or panel track supplement to FDA
- The Sponsorer must complete the eSTAR application
- The pilot program is NOT applicable to IVD devices, Combination products, CBER products or an FDA dual 510(k)/CLIA waiver application.
Limitations of eStar Pilot
- Health Canada will not accept Regulatory Enrollment Process (REP) submission
- Submissions are accepted only in English at present.
Interested device sponsors can send in their participation request at [email protected] and [email protected] with the subject line “Request for participation in eSTAR Pilot”. The participation email should cover the following points:
- A statement asking to participate in the pilot
- Applicant name
- Contact name and title
- Device trade name(s) `
- The FDA primary product code, Global Medical Device Nomenclature (GMDN) and Preferred Name Code (PNC) of your device
- A statement that the same medical device using the eSTAR will be submitted within 6 months of acceptance in the eSTAR pilot to both Health Canada and the FDA:
- For Health Canada: specify if it is a new or significant change amendment for a Class III or IV submission
- For FDA: specify if it is a 510(k), De Novo or PMA submission (specify if the PMA submission is original, 180-day, real-time or a panel track supplement)
The FDA and Health Canada intend to revert to emails within 3 business days. The file size should be Less Than 1 GB, and images and videos to be submitted in compressed format. The fee structure is as follows:
Health Canada
US FDA
Once accepted into eSTAR pilot, FDA & Health Canada will provide the Sponsor with the following items:
- eSTAR to prepare the submission
- Submission process information via the internet and mail service. Sponsorer can choose which route to adopt.
by OMC Medical | Aug 9, 2022 | Canada
Health Canada is the regulator of therapeutic products, including medical devices. Health Canada’s Medical Devices Active Licencing Listing (MDALL) contains a list of products that are already in the Canadian medical device market.
It also contains the database for products that were previously licensed. This article discusses the various information available on MDALL.
Read our article on overview of medical device registration in Canada to understand the various license requirements for different classes of medical devices.
In brief, there are two types of licenses- Medical device establishment license (MDEL) and medical device license (MDL). MDL, the latter of the two, is for medical devices that fall under the category of device class II, III and IV. Medical Device Establishment License (MDEL) is for Class I devices.
The Medical Devices Active Licensing Listing (MDALL) database has the license information of all medical device license or MDL.
The Bureau keeps track of all licenced Class II, III, and IV medical devices for sale in Canada. Class I medical devices do not require a medical device licence and are controlled through Establishment Licensing by the Health Products and Food Branch Inspectorate (Compliance and Enforcement).
There are two types of licenses searches available on MDALL:
- Search Active Licences and
- Search Archived Licences
Search Active license opens the Medical Devices Active Licence Search window. In the Search Active Licence window, only products that are currently licenced for sale in Canada will be displayed.
Health Canada Database Details
This window allows you to search the database using one of six parameters:
- Company Name,
- Licence Name,
- Device Name
- Company ID
- Licence Number and
- Device Identifier
Search Archived license opens the Medical Devices Archive Licence Search box. This section of the system contains data on all items ever licenced by the Medical Devices Bureau, with the query result color-coded.
Obsolete products are displayed in red, while currently, active products are in black. This window provides only three search parameters, which are as follows
- Licence number
- Device name and
- Device identifier
Health Canada cautions users to not import or purchase medical devices that are not permitted for sale in Canada.
FAQs
What is the use of a medical device license database?
A database of medical devices or license helps the end user understand the quality of a product. It also ensures that the device that is in use is easily traced to it manufacturer. Countries like US and Canada have a well-established device database for transparency. Countries that do not have this may have the devices documented but the information may not be accessible to public.
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.