Designated device registration guidance document for new and existing registrants

Definition of designated device

Designated device means a device included in Schedule IX of the Controlled Drugs and Substances Act.

• Pill press: Manual, semi-automatic or fully automatic device — unassembled or fully or partially assembled or disassembled — that may be used to compact or mould powdered, granular or semi-solid material to produce coherent solid tablets.
  • In addition to the pill press, the following parts that are suitable for use in a pill press, but not already part of the device, are also considered designated devices:
    • Dies: hollow cavities located inside the turret where the powder is compressed into tablet shape.
    • Moulds: cavities that creates the shape of the pill often installed at the end of the punch.
    • Punches: components that move downward to compress powder in the die and/or to eject the finished tablet.
• Encapsulator: Manual, semi-automatic or fully automatic device — unassembled or fully or partially assembled or disassembled — that may be used to fill capsules with any powdered, granular, semi-solid or liquid material.

Registration requirements

• Designated devices must be registered with Health Canada in advance of importation.
• As of December 17, 2025, all component parts must be registered with Health Canada prior to importation.
• Customs officials may notify Health Canada and/or law enforcement if an unregistered device or component part arrives at the border.

Declaration of legitimate uses

• Designated devices may be used for legitimate purposes in the pharmaceutical, food and consumer products industries.
• You are required to provide the registration number and proof/confirmation of the registration at the border upon importation of the designated device.
• Further to Canadian Federal legislated requirements, 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.

Process to register a designated device and/or component parts

1. To register a designated device, industries or individuals must complete and submit a registration form. The registration form can be acquired by emailing Health Canada at authorizations-autorisations@hc-sc.gc.ca.
2. Upon receipt of the registration form, Health Canada will review for completeness. The application will be returned to the applicant if it is not complete.
3. Once the registration is complete, Health Canada will issue a registration number and provide a copy of the validated registration form to the applicant. This copy is your proof of registration.

Required information for registering a designated device and component part

• The name, address, and contact details (phone number, e-mail) of the corporation or individual who wishes to register the designated device or component part.
• 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 or component part.
• The address where the designated device or component part will be used.
• The name and address of the customs office where the importation of the designated device or component part is expected.
• The anticipated date of importation of the designated device or component part.

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

• The individual or industry importing the designated device or component part must provide the registration number and validated registration form or proof of registration (for example, a copy of the completed, stamped application form) to border officials along with the import declaration.
• Border officials, at their discretion, may verify the validity of the registration with Health Canada.

Registration process and timelines

• Health Canada aims to process application forms within 15 business days. Incomplete forms will be returned to the applicant and require revisions delaying the approval process. Each designated device or component part must be registered using a separate application form.
• Once the registration has been processed by Health Canada, applicants will be provided with:
  • The registration number for the designated device or component part specified on the form, and
  • A copy of the validated registration form (from Health Canada).

The registration is valid for 2 years. It is only valid for the importation of the device specified or component part on the validated registration form. It can only be used once.

Submission of the registration form

• Application forms can be submitted to Health Canada by e-mail at authorizations-autorisations@hc-sc.gc.ca

Consequences of not registering a designated device before importation

• Failure to register a designated device or component part before importing it into Canada is in violation of the Controlled Drugs and Substances Act.
• Customs officers may seize or detain any designated device under the Customs Act under authority of the Controlled Drugs and Substances Act, if not presented with validated registration.

Questions or comments regarding the registration process

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

Authorizations Division

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