Monthly Archives: April 2016

Update- MI/MCI in Leave-on Cosmetics

By |April 21st, 2016|

In the December 2015 update to the Cosmetic Ingredient Hotlist, a restriction was added to the Methylisothiazolinone/Methylchloroisothiazolinone (MI/MCI) entry. MI/MCI when used in combination is a prohibited substance in leave-on cosmetic products. An implementation of six months was given from the date the change was published in the Cosmetic Ingredient Hotlist for companies […]

GMP Document Review Project

By |April 14th, 2016|

DSA was recently by hired by one of our manufacturing clients in in Asia to determine if their manufacturing documents would meet Health Canada expectations.

Health Canada requires that all GMP records are made available in English or French. The first part of the project for the client, was to undertake translation of all […]

New Evidence Required for Light Emitting Medical Devices

By |April 4th, 2016|

Health Canada has announced that effective immediately evidence will be required to demonstrate that all hazards associated with thermal damage to the skin are eliminated or appropriately mitigated for light emitting medical devices. Affected devices include devices with laser, intense pulsed light (IPL), or light emitting diode (LED) energy sources.

The new evidence requirements impact class III and IV […]

Changes to the Non-prescription Drug Monograph Attestation Process

By |April 4th, 2016|

All non-prescription Category IV Monograph product (DINF) applications must include the new monograph attestation form.

Due to unfavorable results of the monograph attestation pilot, Health Canada has put in place processes to ensure that all DINF applications comply with the monograph.

During the review of DINF applications special attention will be given to the acceptability of medicinal and non-medicinal ingredient […]