Sylvi Shalatski

About DSA

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So far DSA has created 11 blog entries.

How is Health Canada responding to COVID-19?

By |March 23rd, 2020|

Health Canada has been working closely with the Public Health Agency of Canada, as well as with provincial, territorial and international partners to monitor and respond to the COVID-19 Pandemic.

Health Canada will be focusing its efforts on expediting requests related to drugs, medical devices and NHPS that mitigate […]

Our response to current COVID-19 pandemic

By |March 22nd, 2020|

Due to the current COVID-19 pandemic, things are changing around us at incredible speed, and at DSA we are adapting our operations and business to keep our employees, clients and community safe.

Given that our clients include manufacturers and importers of critical medicines and infection control products, we are doing […]

Intent to Reclassify Disinfectants and Sterilants for Use on Medical Devices

By |October 18th, 2016|

Currently, disinfectants and sterilants that are intended for use on medical devices are regulated as drugs under the Food and Drug Regulations. However, Health Canada has communicated that they intend to reclassify these products as medical devices which means that disinfectants and sterilants used on medical devices would be subject to the requirements of the […]

Transition to ISO 13485:2016

By |October 4th, 2016|

ISO will withdraw ISO 13485:2003 on March 1, 2019, three years after the publication of ISO 13485:2016.

All Canadian and Foreign manufacturers of class II, III, and IV medical devices holding licences or applying for new or amended licences must complete the transition to ISO 13485:2016 by March 1, 2019.

Manufacturers which have not transitioned to ISO […]

Decorative Contact Lenses Classification

By |June 30th, 2016|

As of July 16, 2016, decorative contact lenses will be regulated as Class II medical devices in Canada.

Manufacturers will be required to obtain a medical device licence before advertising or selling decorative contact lenses.

Health Canada will be implementing a 12-month transition period to allow manufacturers of decorative contact lenses to obtain their Class II medical device licence.

After […]

Access to Information Requests

By |May 23rd, 2016|

The Access to Information (ATI) Act allows Canadians to request copies of files which are within the government’s domain. ATI requests are often used within our industry to request copies of Product Registration Dossiers and even Health Canada Inspection Reports.   The government is obligated to compile the data requests and then provide these records to the subject of […]

Thank you for your referrals!

By |May 17th, 2016|

DSA is frequently approached by companies who want to seek us out as potential advertisers. Most are surprised to learn that DSA does not engage in traditional advertising models. We don’t go looking for clients; they find us. While clients find us in a number of ways; mostly they find us through referrals from our existing clients. We […]

Commercial Reprocessing of Medical Devices Originally Labelled for Single Use

By |May 11th, 2016|

Single-use medical devices are those labelled by their manufacturers to be used only once. For many years hospitals have been reprocessing some medical devices originally labelled for single use for cost savings. Reprocessing includes cleaning, sterilising and disinfecting.

However more and more hospitals are outsourcing reprocessing to outside companies. Although hospitals will continue to be permitted […]

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 […]