regulatory affairs Canada

02 Jun 2026

Health Canada Melatonin Update: Pediatric Use to Become Prescription-Only

DrugsFood and Drug Regulations, health canada, Melatonin, natural health products, NHP compliance, Pediatric Melatonin, Pediatric Sleep Products, Prescription Drug List, regulatory affairs Canada

Health Canada has announced an amendment to the human use section of the Prescription Drug List for “melatonin or its salts.” Effective June 2, 2026, melatonin products sold for sleep-related use in children and adolescents under 18 years of age will be classified as prescription drugs under the Food and Drug…

Health Canada NHP Site Licence Renewal Process and Requirements

NHP Site Licensingforeign site GMP evidence, GMP requirements, Health Canada compliance, Natural Health Products regulations, NHP site licence renewal, NNHPD guidance, QAP responsibilities, regulatory affairs Canada, renewal timelines, site licence amendment

All Natural Health Product (NHP) site licence holders in Canada must renew their licence in accordance with the Natural Health Products Regulations. Although the renewal term varies by licence and is assigned directly by Health Canada, the obligation remains consistent across all sites: confirm continued compliance with Part 3 Good Manufacturing Practices (GMP) and keep Health…

Contraceptive Device Licensing in Canada: A Quick Overview

Medical Devicescontraceptive device classification, contraceptive labelling Canada, contraceptive medical devices, contraceptive product compliance, Health Canada medical device licensing, ISO 13485 compliance, IUD licensing Canada, MDEL Canada, MDL Canada, medical device application Canada, medical device regulations Canada, post-market surveillance Canada, regulatory affairs Canada, SNI regulatory support

The process of bringing contraceptive medical devices to the Canadian market involves navigating a clearly defined but often complex regulatory framework. Products such as intrauterine devices (IUDs), diaphragms, condoms, and contraceptive sponges are considered medical devices and are regulated by Health Canada under the Medical Devices Regulations. This overview outlines…