Designated Devices Registry Guidance Document

Permits Section – Authorizations Division

Definition of designated devices

• Pill press: Manual, semi-automatic or fully automatic device that may be used to compact or mould powdered, granular or semi-solid material to produce coherent solid tablets
• Encapsulator: Manual, semi-automatic or fully automatic device that may be used to fill capsules with any powdered, granular, semi-solid or liquid material 

Anyone wishing to import a designated device must register the designated device with Health Canada prior to importation

• The requirement for registration would require designated devices to be registered with Health Canada.
• Customs officials may notify Health Canada and/or law enforcement if an unregistered device arrives at the border.

Legitimate purposes of designated devices and legislation

• Designated devices may be used for legitimate purposes in the pharmaceutical, food and consumer products industries.
• Any individual or industry who will be importing a designated device into Canada after May 18, 2017 should register the device with Health Canada.
• Legitimate users are required to register any designated device they wish to import with Health Canada.
• Legitimate users are required to provide the registration number and proof/confirmation of the registration at the border upon importation of the designated device.
• Registration is not onerous; the burden on legitimate manufacturers is limited.
• On January 15, 2019, the Province of British Columbia brought into force the Pill Press and Related Equipment Control Act.  This Act restricts who can lawfully own, use, possess or sell equipment such as automated tablet presses and encapsulators, pharmaceutical mixers as well as associated dies, moulds and punches.  For more detail on obligations under the Act, please visit the Pill Press and Related Equipment Control Act web page at www.gov.bc.ca/pill-press.

Process to register a designated device

• Industry or individuals who wish to register a designated device are required to complete and submit a registration form.
• The registration form is available online.
• Upon receipt of the registration form, Health Canada will screen it for completeness. The application will be returned to the applicant if it is not complete.
• If the registration is complete, Health Canada will issue a registration number and copy of the registration form to the applicant. 

Required information for registering a designated device

• The name, address, and contact details (phone number, e-mail) of the corporation or individual who wishes to register the designated device.
• A description of the designated device, including the model number, serial number, and brand name or trademark (if any).
• The address of delivery of the designated device.
• The address where the designated device will be used.
• The name and address of the customs office where the importation of the designated device is expected.
• The anticipated date of importation of the designated device.

Importers must provide proof of registration of the designated device to border officials

• The individual or industry importing the designated device must provide the registration number and proof of registration (e.g., a copy of the completed, stamped application form) to border officials along with the importation documents.
• Border officials, at their discretion, may verify registration with Health Canada.

The registration process/timelines

• Health Canada aims to process completed application forms with 15 business days. Incomplete forms will be returned to the applicant and delay the registration process. Applicants are therefore encouraged to ensure they have provided the complete form.
• Health Canada encourages applicants to ensure that the application for registration is complete and submitted in good time.
• Each designated device must be registered using a separate application form.
• As the form is one page and not onerous to complete, this is a limited burden on individuals or industries wishing to register a designated device.
• Once the registration has been processed by Health Canada, applicants will be provided with:
  • The registration number for the designated device specified on the form, and
  • A copy of the validated registration form (from Health Canada).
• The registration is valid for two years. It is only valid for importation of the device specific on the form.

Submission of registration form

• Application forms can be submitted to Health Canada by mail or electronically (e-mail).
• Mailing address:

  Authorizations Division
  Office of Controlled Substances
  Controlled Substances Directorate
  Health Canada
  161 Goldenrod Driveway, AL0300B
  Ottawa, ON K1A 0K9

• Email: hc.authorizations-autorisations.sc@canada.ca

Failure to register a designated device prior to importing it into Canada

• Failure to register a designated device before importing it across the Canadian border is in violation of the Controlled Drugs and Substances Act.
• Customs officers may notify Health Canada and/or law enforcement when the device arrives at the border.

Questions/comments regarding the application process

• If you have any questions regarding the application/registration process, please contact:

Authorizations Division

E-mail: hc.authorizations-autorisations.sc@canada.ca