MedCare Medical Devices Canada

MedCare Medical Devices Canada MedCare Medical Devices Canada is the US FDA and Health Canada regulatory consulting firm. MedCare Medical Devices Canada is a regulatory consulting firm.

We assist manufacturers from around the world in navigating the Health Canada and FDA regulatory approvals processes, for their innovative medical devices. Our experience ranges from Point Of Care testing and diagnostics, through to mobility devices and Telehealth products. Service Offering Overview:

Regulatory Consulting for Health Canada and U.S. FDA
- FDA and Health Canada Regulatory Services

- Regulatory and Classification Research and pre-submission
- Medical Device Classification and Licensing
- MDL, MDEL, MDSAP Program Compliance Services
- Protocol Building and Submission (Clinical Trials)
- Ethics Board Applications
- MDEL Utilization For Importation of Medical Devices
- Document Preparation and Submission
- Regulatory Correspondent on behalf of Manufacturer
- Product Development Services
- Product Quality Control Services
- FDA Product Registration Management
- FDA ISO-13485 Certified Manufacturing Services
- FDA 510(k) Generation, Review, and Submissions

Importation and Logistics
- Importation and Logistics Coordination
- Customs Regulatory Consulting
- Customs Clearance and Declarations
- Ground/Air/Sea Transport
- Local Courier

10/06/2021

MedCare Medical Devices Canada is listed with Innovation, Science and Economic Development Canada - Life Science Industries Directorate. English: Canada.ca/pharma-services
Français : Canada.ca/services-pharma

Les organismes de recherche clinique (ORC) et les organismes de fabrication sous contrat (OFC) comptent parmi les secteurs de croissance les plus dynamiques de l'industrie des sciences de la vie.

Visit MedCare Medical Devices Canada at Canada’s Medtech Conference.DATE:  Tuesday, October 5 and Wednesday, October 6TI...
10/05/2021

Visit MedCare Medical Devices Canada at Canada’s Medtech Conference.

DATE: Tuesday, October 5 and Wednesday, October 6
TIME: 10:00 am to 1:00 pm Eastern

Rosh Hashana, the Jewish New Year, is upon us once again. We at MedCare Medical Devices Canada would like to take a mome...
09/04/2021

Rosh Hashana, the Jewish New Year, is upon us once again. We at MedCare Medical Devices Canada would like to take a moment to reflect on the challenges of the last year and to extend our most heartfelt hopes for safety, health, peace and prosperity for all, this coming year.

To our many friends, family members and colleagues who are celebrating the Rosh Hashana holiday, we'd like to wish you and your loved ones a "Shana Tova" and a sweet New Year.

The future is now! Osentia is getting geared up to shine a laser light on Osteoporosis in Canada. Stay tuned for more up...
04/16/2021

The future is now! Osentia is getting geared up to shine a laser light on Osteoporosis in Canada. Stay tuned for more updates on this exciting new approach to the screening and prevention of one of the developed world's most devastating diseases.

Metrohm - feel free to use this photo.
Rene Beattie and Alan Ransome - thank you for your help and support!

Face masks that contain graphene may pose health risks.April 2, 2021 - Health Canada is advising Canadians not to use fa...
04/05/2021

Face masks that contain graphene may pose health risks.
April 2, 2021 - Health Canada is advising Canadians not to use face masks that contain graphene because there is a potential that they could inhale graphene particles, which may pose health risks.
Graphene is a novel nanomaterial (materials made of tiny particles) reported to have antiviral and antibacterial properties. Health Canada conducted a preliminary scientific assessment after being made aware that masks containing graphene have been sold with COVID-19 claims and used by adults and children in schools and daycares. Health Canada believes they may also have been distributed for use in health care settings.

Health Canada is advising Canadians not to use face masks that contain graphene because there is a potential that they could inhale graphene particles, which may pose health risks.

Newest Weapon in the Fight Against COVID 19 - Bi-Polar Ionization System Tests Positive for Killing CoronavirusThe scien...
03/29/2021

Newest Weapon in the Fight Against COVID 19 - Bi-Polar Ionization System Tests Positive for Killing Coronavirus

The scientific study was conducted by Hylabs and followed the stringent guidelines developed by the Israeli Ministry of Health. The tests concluded that the Sterionizer D6 and D5 units were capable of inactivating hCoV-OC43; an acceptable model for SARS-CoV-2 which causes COVID-19. Medcare Medical Devices Canada is a Canadian importer and authorized distributor of the Sterionizer family of ionizer systems. They have the products registered under their MDEL license with Health Canada.

Medcare Medical Devices Canada has received the official word that their bi-polar ionization systems have recently been certified as capable of reducing Coronavirus particles in the air by greater than 99%.

While no cytotoxic effect to MRC5 cells was observed, the viral log reduction of the Coronavirus particles was an average of 2.13 or greater than 99%. As per ISO 18184:2019 standards, this reduction in viral load is classified as “significant” and as such these ionization units are deemed a highly effective means of controlling the spread of this highly infectious disease.

The scientific study was conducted by Hylabs and followed the stringent guidelines developed by the Israeli Ministry of Health. The tests concluded that the Sterionizer D6 and D5 units were capable of inactivating hCoV-OC43; an acceptable model for SARS-CoV-2 which causes COVID-19. Medcare Medical D...

International Medical Device Regulators ForumLive Stream - IMDRF Stakeholder Virtual Forum (Sessions 1-3) - March 23 202...
03/23/2021

International Medical Device Regulators Forum

Live Stream - IMDRF Stakeholder Virtual Forum (Sessions 1-3) - March 23 2021

News from Ontario: The province is making it easier to administer rapid COVID-19 testing in the workplace.The province h...
03/17/2021

News from Ontario: The province is making it easier to administer rapid COVID-19 testing in the workplace.

The province has also removed regulatory barriers governing the use of COVID-19 tests that are approved by Health Canada for point-of-care use to make it easier for organizations to offer onsite testing and support a safe return to work. This change will especially benefit rural and remote communities including Northern Indigenous communities where health professionals required to administer testing are limited.
https://news.ontario.ca/en/release/60745/ontario-making-it-easier-to-administer-rapid-covid-19-testing-in-the-workplace

"By expanding rapid testing in the workplace and making it easier to administer, we will be able to maintain critical infrastructure and keep people working," said Vic Fedeli, Minister of Economic Development, Job Creation and Trade. "These measures are essential to further protect Ontario's work...

Medical device manufacturers and importers, do not mark your devices "For Research Use Only" to fast-track these devices...
03/08/2021

Medical device manufacturers and importers, do not mark your devices "For Research Use Only" to fast-track these devices to Canada for clinical trial or clinical diagnostic purposes or for other use with humans.

Details on "For Research Use Only" labelling: when this label can be applied and the restrictions for these testing devices

If you're interested in the number of covid-19 related tests authorized in Canada, read this page on the Health Canada w...
02/27/2021

If you're interested in the number of covid-19 related tests authorized in Canada, read this page on the Health Canada website.

Searchable list includes all authorized medical devices for sale or import in Canada under the Interim Order.

02/19/2021
Are you importing or exporting COVID-19 related medical devices to Canada? Remember to add term ‘URGENT – COVID-19’ and ...
01/26/2021

Are you importing or exporting COVID-19 related medical devices to Canada? Remember to add term ‘URGENT – COVID-19’ and choose proper Tariff Classification, as per Customs Notice 20-12:

Tariff Classification and Other Information to Import Medical Supplies

https://www.cbsa-asfc.gc.ca/publications/cn-ad/cn20-12-eng.html

New Weapon In The Fight Against Osteoporosis. Osentia Osteoporosis Test Kit only requires a pen and a nail clipping.Toro...
12/28/2020

New Weapon In The Fight Against Osteoporosis.
Osentia Osteoporosis Test Kit only requires a pen and a nail clipping.

Toronto, ON (Canada) - December 27, 2020 – Medcare Medical Devices Canada has signed an agreement with Crescent Ops Ltd. (UK) for the exclusive distribution of the Osentia Osteoporosis Test Kit, in Canada.

Osentia is a patented, Health Canada approved, professional laboratory test that uses Raman Spectroscopy screening technology to assess a patient’s risk of fragility fractures due to Osteoporosis. The new test requires only a single clipping of a fingernail or toenail. This is put in a small plastic bag, supplied in the kit, and sent to a lab along with a health assessment form. This includes questions on personal health, such as diet, lifestyle, age and exercise.

Tests are then carried out on the nail sample to assess the structure of the protein keratin in the nail. This is a key indicator of whether a person is at risk of fragility fractures, weak bones and potential osteoporosis. A risk profile report is returned via email or post within seven working days.

Everyone has some risk of developing osteoporosis, which is often undiagnosed until the time they fracture a bone. The major public health and clinical impact of osteoporosis lies in the fractures caused by the disease. About 28% of women and 37% of men die within 1 year of suffering a hip fracture. It has been estimated that 50% of women who sustain a hip fracture become functionally dependent in their daily activities, and 19% require long-term nursing home care. It is therefore important to identify the risk of osteoporosis early enough to take steps to help prevent and minimize the development of the condition and to reduce the risk of fracture.

The national launch of the Osentia Osteoporosis Test Kit is scheduled for Q1, 2021.

About Medcare Medical Devices Canada:
Medcare Medical Devices Canada is a Canadian importer, distributor and regulatory consulting firm specializing in rapid diagnostics, point of care, telehealth, patient comfort and digital health products.

Contact:
Eugene P*k
CEO
Medcare Medical Devices Canada
1-888-821-3888
Eugene.pik@MedicalDevicesCanada.com

http://osentia.ca
https://MedicalDevicesCanada.com

SEASONS GREETINGS!!In this truly unique holiday season, the Medcare team would like to sincerely wish all of our friends...
12/24/2020

SEASONS GREETINGS!!

In this truly unique holiday season, the Medcare team would like to sincerely wish all of our friends, family, colleagues, partners and customers a very, VERY Happy Holidays, Merry Christmas and Happy New Year.

We pray that the coming year delivers an over-abundance of light, joy, happiness, good health and prosperity for all!

Following extensive consultations with the Ministry of Education, teachers, support staff, child development specialists...
08/26/2020

Following extensive consultations with the Ministry of Education, teachers, support staff, child development specialists and parents, it is clear that in order to facilitate a safe return to school this fall, significant steps will still need to be taken. Based on the guidance we obtained, Medical Devices Canada created the “Get-Back Pack” to help public and private schools achieve the important goal of a safe, successful re-opening.

The “Get-Back Pack” represents the gold standard in back-to-school solutions for organizations that are committed to ensuring the highest levels of safety and the cleanest learning environments for their returning staff, students, parents and other visitors.

Our unique one-stop-shop approach ensures our clients can support all of their needs, with just a single point of contact. The solutions in the package range from systems to purify the air in your facility, equipment to automatically check temperatures and make sure that everyone who enters your premises is wearing a mask, hand sanitizer, anti-viral reusable and disposable masks and more. A full range of PPE and other essentials are also available to ensure you have all of the necessities required, at all times.

Following extensive consultations with the Ministry of Education, teachers, support staff, child development specialists and parents, it is clear that in order to facilitate a safe return to school this fall, significant steps will still need to be taken. Based on the guidance we obtained, Medic...

07/09/2020

Address

Concord, ON

Alerts

Be the first to know and let us send you an email when MedCare Medical Devices Canada posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Contact The Practice

Send a message to MedCare Medical Devices Canada:

Share