Designated device registration guidance document for new and existing registrants

On this page

• Summary
• Definition of designated device
• Registration requirements
• Declaration of legitimate uses
• Process to register a designated device and/or component parts
• Required information for registering a designated device and component part
• Importers must provide proof of registration of the designated device or component part to border officials
• Registration process and timelines
• Submission of the registration form
• Consequences of not registering a designated device before importation
• Questions or comments regarding the registration process
• Note about guidance documents in general

Summary

Overview

This guidance document provides information on how to register designated devices and component parts prior to importation into Canada using the Designated Device Importation Application on GC Forms.

All designated devices must be registered in accordance with section 46.3 of the Controlled Drugs and Substances Act.

Important notice

All commercial importers must have a business number for any import/export account with the Canada Border Services Agency.

Who this guide is for

• Pharmaceutical, Food and consumer product industry
• Individuals thinking about becoming importers of designated devices
• Individuals planning to import a designated device

Details and history

Published: June 18, 2026
Part of topic(s): Canadian Drugs and Substances Strategy

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.
• Encapsulation device: 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.
• 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

To register a designated device or component part:

1. Complete and submit the Designated Device Importation Application using GC Forms, providing all required information.
2. Upon receipt of the registration form, Health Canada will review for completeness. The applicant will be contacted and be asked to resubmit the Registration Form if the application is not complete.
3. Once the registration is complete, Health Canada will issue a registration number and provide the Designated Device Registration 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.
• Details of the designated device(s), including the total number of devices to be imported, as well as the model number, serial number, and brand name.
• Required information for component parts includes:
  1. Identification of the device for which the parts are intended to be used for.
  2. A breakdown of the contents of the shipment, specifying the quantity of each type of device or component part being imported.
• The address of delivery of the designated device or component part.
• The address where the designated device and/or component part will be used.
• The name and address of the customs office where the importation of the designated device and/or component part is expected.
• The anticipated date of importation of the designated device and/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 a copy of the validated registration form issued by Health Canada 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.
• 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 through the Designated Device Importation Application using GC Forms.

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

Health Canada aims to respond to all inquiries related to designated devices within two (2) business days.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the Regulations and other applicable guidance documents.