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24

Nov 2022

What is Real-World Evidence?
What is Real-World Evidence?
By
Real-world data (RWD) and real-world evidence (RWE) are becoming an integral part of health care decisions such as in the approving process, in clinical practice, in generating innovative, and new […] Read More >>

23

Nov 2022

FDA Issues Warning Letters to Seven Dietary Supplement Manufacturers for Using Drug Claims
FDA Issues Warning Letters to Seven Dietary Supplement Manufacturers for Using Drug Claims
By
On Thursday, November 17, 2022, the Center for Food Safety and Applied Nutrition issued seven warning letters to manufacturers of supplements marketed for the promotion of cardiovascular health. The dietary […] Read More >>

14

Nov 2022

FDA Concludes that Nicotinamide Mononucleotide (NMN) Cannot be Marketed or Sold in Dietary Supplements
FDA Concludes that Nicotinamide Mononucleotide (NMN) Cannot be Marketed or Sold in Dietary Supplements
By
The FDA recently published responses to several new dietary ingredient notifications (NDIN) submitted for nicotinamide mononucleotide (most notably the November 8, 2022 response to Inner Mongolia Kingdomway Pharmaceutical Ltd. “Kingdomway”). […] Read More >>

03

Nov 2022

Monkeypox Testing – U.S Pathways to Licensing
Monkeypox Testing – U.S Pathways to Licensing
By
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. Usually endemic to regions of central and […] Read More >>

25

Oct 2022

GRAS, New Dietary Ingredients (NDI’s), Old Dietary Ingredients (ODI’s), and Food Additives – Is Your Product Classified Correctly?
GRAS, New Dietary Ingredients (NDI’s), Old Dietary Ingredients (ODI’s), and Food Additives – Is Your Product Classified Correctly?
By
To be used in foods and dietary supplements, ingredients must: be determined to be Generally Recognized as Safe (GRAS), be approved as a New Dietary Ingredient (NDI), be considered an […] Read More >>

21

Oct 2022

What is the Difference Between a DIN and an NPN?
What is the Difference Between a DIN and an NPN?
By
Bringing a drug or a natural health product to market in Canada involves applying for an 8-digit numerical code, called a DIN for drugs, or an NPN for natural health […] Read More >>

22

Sep 2022

Monkeypox Testing – Canadian Pathways to Licensing
Monkeypox Testing – Canadian Pathways to Licensing
By
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. While appearing similar to smallpox, it is […] Read More >>

26

Jul 2022

Health Canada Introduces New Regulatory Framework for the Sale of Supplemented Foods
Health Canada Introduces New Regulatory Framework for the Sale of Supplemented Foods
By
On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations (FDR), introducing new regulations for supplemented foods as a category. These new regulations continue to protect […] Read More >>

26

Jul 2022

Changes to Natural Health Product Regulations (NHPR) Labelling Requirements
Changes to Natural Health Product Regulations (NHPR) Labelling Requirements
By
New labelling requirements announced by Health Canada in Canada Gazette, Part II, Volume 156, Number 14 titled “Regulations Amending the Natural Health Products Regulations” have come into effect as of […] Read More >>

12

Jul 2022

How Much Does it Cost to Get an MDEL & MDL Approval?
How Much Does it Cost to Get an MDEL & MDL Approval?
By
The cost to obtain an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada depends on the medical device’s classification. In this blog, we will break down […] Read More >>

05

Jul 2022

What is Bioanalytical Testing?
What is Bioanalytical Testing?
By
Bioanalysis is the quantitative evaluation of analytes/substances in biological matrices such as tissue, blood, serum, urine, or other body fluids. Bioanalytical testing involves using a validated bioanalytical method for the […] Read More >>

15

Jun 2022

How Much Does it Cost to Get a 510(K) Approval?
How Much Does it Cost to Get a 510(K) Approval?
By
This blog is meant to be an overview of the average costs associated with bringing a medical device to market under normal circumstances. Depending on when you are reading this […] Read More >>

31

May 2022

ALERT: New European Union In Vitro Diagnostics Regulations (EU IVDR) to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC)
ALERT: New European Union In Vitro Diagnostics Regulations (EU IVDR) to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC)
By
The new European Union In Vitro Diagnostics Regulations (EU IVDR) entered into application on May 26, 2022, to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC). Manufacturers, authorized representatives, importers, and […] Read More >>

13

May 2022

EU In Vitro Diagnostic Medical Device Regulation
EU In Vitro Diagnostic Medical Device Regulation
By
In vitro diagnostic medical devices contain a broad spectrum of devices that test biological samples to determine the status of one’s health, from self-tests for pregnancy, to blood glucose tests […] Read More >>

29

Apr 2022

What You Need to Know about EFSA Strategy 2027
What You Need to Know about EFSA Strategy 2027
By
EFSA’s Strategy 2027 delineates the European Food Safety Authority (EFSA) strategies and approaches in responding to the changing environment in the years ahead, especially in light of the SARS-CoV-2 global […] Read More >>

19

Apr 2022

Interim Order Number 3 for Medical Devices is Now in Effect.
Interim Order Number 3 for Medical Devices is Now in Effect.
By
Health Canada’s use of Interim Orders (IOs) has allowed for the exceptional importation and sale of Medical Devices (MDs) to help prevent shortages in relation to COVID-19. To date, Health […] Read More >>

14

Apr 2022

How to Get a CE for a Medical Device
How to Get a CE for a Medical Device
By
Medical devices in the European Union (EU) are approved through a different mechanism than the approval process in the United States or Canada. The approval of medical devices intended for […] Read More >>

28

Mar 2022

How is Digital Health Regulated in Canada?
How is Digital Health Regulated in Canada?
By
As innovation continues to evolve in digital health technologies, Health Canada is undertaking an adaptive initiative to support better access to those therapeutic products, especially in relation to medical devices. […] Read More >>

18

Mar 2022

How is Digital Health Regulated in the U.S?
How is Digital Health Regulated in the U.S?
By
Digital Health covers a broad scope of categories in mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Digital health tools range from mobile medical […] Read More >>

18

Mar 2022

New Compliance Date Set for Health Canada’s 5-year Food Labelling Changes Plan
New Compliance Date Set for Health Canada’s 5-year Food Labelling Changes Plan
By
Health Canada has announced December 14, 2022, as the new date for when the Canadian Food Inspection Agency’s (CFIA) updated food labelling regulations (which came into effect on December 14, […] Read More >>

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