Distribution date: 12 June 2020

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Addendum to Regular Notification

Distribution date: 12 June 2020

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Addendum to Regular Notification

Distribution date: 11 June 2020

This resolution extraordinarily and temporarily establishes the submission procedure for clinical studies required to validate medical devices of Classes III and IV identified as essential to healthcare services, due to the international public health emergency related to the SARS-CoV-2.

Products Covered: HS Code(s): medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)

Regulation Type: Regular notification

Distribution date: 11 June 2020

This resolution extraordinarily and temporarily establishes the submission procedure for clinical studies required to validate medical devices of Classes III and IV identified as essential to healthcare services, due to the international public health emergency related to the SARS-CoV-2.

Products Covered: HS Code(s): medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)

Regulation Type: Regular notification

Distribution date: 11 June 2020

This resolution extraordinarily and temporarily establishes technical requirements for the import, marketing, and donation of lung ventilators, vital signs monitor, infusion pump sets, oximetry machine, and used capnographs, indispensable for intensive care units, due to the international public health emergency related to the Covid-19. 

Products Covered: HS Code(s): Medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)

Regulation Type: Regular notification

Distribution date: 11 June 2020

This resolution extraordinarily and temporarily establishes technical requirements for the import, marketing, and donation of lung ventilators, vital signs monitor, infusion pump sets, oximetry machine, and used capnographs, indispensable for intensive care units, due to the international public health emergency related to the Covid-19. 

Products Covered: HS Code(s): Medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)

Regulation Type: Regular notification

Distribution date: 11 June 2020 | Final date for Comment: 10 July 2020

This draft resolution changes the Resolution – RDC number 73, 7 April 2016, which establishes technical requirements for post-registration changes and cancellation procedures for registering medicines.

Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).

Regulation Type: Regular notification

Distribution date: 11 June 2020 | Final date for Comment: 10 July 2020

This draft resolution changes the Resolution – RDC number 73, 7 April 2016, which establishes technical requirements for post-registration changes and cancellation procedures for registering medicines.

Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).

Regulation Type: Regular notification

Distribution date: 04 June 2020 | Final date for Comment: 01 August 2020

On occasion, Health Canada may identify the need to make changes to the Lists of Permitted Food Additives in order to correct minor errors, to adjust wording in the interest of clarity, to ensure consistency in terminology, or to make changes that are required as a consequence of amendments to the Food and Drug Regulations (Regulations) or emerging scientific developments related to the effectiveness and/or safety of an approved food additive. Health Canada's Food Directorate received a request seeking approval for the use of sodium benzoate as a preservative used at a maximum level of 1,000 ppm in oyster-flavoured sauce. Oyster-flavoured sauce is regulated as an unstandardized fish product in Canada, and consequently, is not permitted to contain either benzoic acid or salts of benzoic acid due to the exception captured under subitem B.1(2) of Part 2 of the List of Permitted Preservatives. The Food Directorate conducted an internal review of its files to understand the rationale behind the establishment of the exception, and found no scientific evidence, from a health and safety perspective, to soundly rationalize the establishment of the exception. In addition, emerging scientific developments have demonstrated the effective anti-microbiological activities of benzoic acid and its salts when used for the preservation of meat, poultry and fish products. Therefore, Health Canada has enabled the use of benzoic acid and its potassium and sodium salts described in the information document by modifying Part 2 of the List of Permitted Preservatives, effective 5 May 2020. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or feedback on this modification.

Products Covered: Benzoic Acid and its Salt (ICS Codes: 67.200.20, 67.120.30)

Regulation Type: Regular notification

Distribution date: 04 June 2020 | Final date for Comment: 01 August 2020

On occasion, Health Canada may identify the need to make changes to the Lists of Permitted Food Additives in order to correct minor errors, to adjust wording in the interest of clarity, to ensure consistency in terminology, or to make changes that are required as a consequence of amendments to the Food and Drug Regulations (Regulations) or emerging scientific developments related to the effectiveness and/or safety of an approved food additive. Health Canada's Food Directorate received a request seeking approval for the use of sodium benzoate as a preservative used at a maximum level of 1,000 ppm in oyster-flavoured sauce. Oyster-flavoured sauce is regulated as an unstandardized fish product in Canada, and consequently, is not permitted to contain either benzoic acid or salts of benzoic acid due to the exception captured under subitem B.1(2) of Part 2 of the List of Permitted Preservatives. The Food Directorate conducted an internal review of its files to understand the rationale behind the establishment of the exception, and found no scientific evidence, from a health and safety perspective, to soundly rationalize the establishment of the exception. In addition, emerging scientific developments have demonstrated the effective anti-microbiological activities of benzoic acid and its salts when used for the preservation of meat, poultry and fish products. Therefore, Health Canada has enabled the use of benzoic acid and its potassium and sodium salts described in the information document by modifying Part 2 of the List of Permitted Preservatives, effective 5 May 2020. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or feedback on this modification.

Products Covered: Benzoic Acid and its Salt (ICS Codes: 67.200.20, 67.120.30)

Regulation Type: Regular notification