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How is Digital Health Regulated in Canada

WEBHealth Canada, as the federal regulator, is supporting the application of digital health technologies to ensure the growing demands are met and only safe and …

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URL: https://dicentra.com/blog/regulatory-compliance-consultants/how-is-digital-health-regulated-in-canada

Regulatory Submissions for Medical Devices dicentra.com

WEBBelow are the following types of submissions dicentra can help prepare in the United States: Establishment Registration – An establishment registration, or facility registration, is …

Category: Health Go Health

Differences Between Food and Supplement Labelling

WEBFirst, the name of the nutrition table is called “ Nutrition Facts ” for foods and “ Supplement Facts ” for dietary supplements. The major differences between them are …

Category: Supplements, Nutrition, Food Go Health

Update on Health Canada's Monograph Revision Plan: Batch 2

WEBThe NNHPD released Batch 2 of the revised draft monographs for consultation on January 31, 2024. This batch comprises 27 updated monographs, …

Category: Health Go Health

What to consider when creating a Brand Name for your NHP

WEBA “Brand Name” is defined as the name under which your NHP (Natural Health Product) is registered or sold. Selecting a “Brand Name” for your NHP is an …

Category: Health Go Health

NHP Regulatory Consulting & Product Site Licensing

WEBdicentra is an expert in NHP (natural health products) licensing. We are familiar with all submission types (e.g. non-traditional) and categories (e.g. enzymes).We have …

Category: Health Go Health

How to get an NPN for your Natural Health Product in Canada

WEBObtaining an NPN. To obtain an NPN, you must file a Product Licence Application (PLA) with the NNHPD. The PLA is the pre-market approval pathway for …

Category: Health Go Health

What Does a Clinical Trial Cost in Canada

WEBA site qualification visit (SQV), a site initiation visit (SIV), an interim monitoring visit (IMV), and a close-out visit (COV). The overall cost here is assuming each of these visits takes …

Category: Health Go Health

Proposed Changes to the Quality (Chemistry and Manufacturing) …

WEBOn December 22, 2022, Health Canada opened consultation on a proposal to amend the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions …

Category: Health Go Health

Health Canada Modernizing the Regulatory Framework for

WEBJune 11, 2021 By dicentra. In May of 2021, Health Canada announced a proposal to modernize the regulatory framework for Clinical Trials. This proposal hopes to help …

Category: Health Go Health

Novel Food Notifications • dicentra

WEBNovel Food Notifications and Food Additive Submissions. Novel Food Notifications must be completed and submitted to Health Canada prior to selling a novel food in the Canadian …

Category: Food Go Health

Regulatory Requirements for Advertising of Health Products

WEBHealth Canada is the national regulatory authority for health product advertisements, overseeing regulated advertising activities, and providing policies to …

Category: Health Go Health

MDEL Annual Licence Renewal (ALR) Due April 1, 2023

WEBMarch 14, 2023 By dicentra. The ALR application due date for MDELs is April 1, 2023. If you hold a Medical Device Establishment Licence (MDEL), you must submit your …

Category: Medical Go Health

The NHP GMP Inspection Pilot Program is Here – Are You Ready

WEBMarch 9, 2021 By dicentra. Health Canada’s new NHP GMP Inspection Pilot Program is here and depending on the outcome, it could be here to stay. If made permanent, this …

Category: Health Go Health

Bill C-47 Enacted in Canada Granting Health Canada Increased

WEBOn June 22, 2023, Bill C-47 received Royal Assent, introducing amendments to the Food and Drugs Act (FDA) concerning Natural Health Products (NHPs). These amendments …

Category: Food Go Health

NNHPD Announces NHP Monograph Revision Consultation Plan

WEBMonograph Revisions: The NNHPD plans to revise 97 NHP monographs in 4 batches (20-25 monographs per batch) between October 2023 and December 2024. …

Category: Health Go Health

Health Canada Draft Guidance: Disaggregated Data in Clinical …

WEBOn December 17, 2022, Health Canada pre-published in Canada Gazette Part I, amendments to the Food and Drug Regulations (FDR).. Health Canada is …

Category: Food Go Health

Supplemented Foods Update: TMAL Extension & Proposed Final

WEBNovember 23, 2021 By dicentra. Health Canada has recently notified the industry that TMAL (Temporary Marketing Authorization Letter) holders for supplemented foods (and …

Category: Food Go Health