The Advertising Code 2018 vs. ISO 15223-1

The Advertising Code 2018 vs. ISO 15223-1
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Do you need to comply with the Advertising Code 2018 if you already comply with ISO 15223-1?

The answer is yes! Selling medical devices on global markets requires that labelling must comply with local region labelling and advertising requirements. Each country will have specific requirements, so how are they addressed to satisfy Australian Market requirements?

First thing to consider for your device, does the labelling requirements meet the Essential Principle 13.1, schedule 1, Part 2. This information can be depicted with the use of symbols defined in ISO15223-1 Medical Devices – Symbols to be used with medical device labelling and information to be supplied – Part 1: General requirements. The application of this standard to device labelling allows the use of symbols to communicate requirements; product characteristics and handling and storage conditions etc. Even though your device may comply with the Essential Principle and the international standard for labelling, this is not the totality of requirements for labelling in Australia, there are local obligations for advertisement to consider and, this is the Therapeutic Goods Advertising Code (No. 2) 2018.

A new advertising code came into effect 01 Jan 2019, Therapeutic Goods Advertising Code (No. 2) 2018. This version is more explicit in its requirements for warning statements which need to be complied with for medical devices. The impact to medical devices is the addition of a health warning to the labelling.

Below are examples of the requirements of the advertising code, refer to the Advertising Code for the exact requirements.

“An advertisement for a medical device must contain the following;

  1. An accurate description of the device;
  2. Either-
    • If the trade name for the device is available-a reference to that name;
    • Otherwise-a reference to another name for the device; or
  3. the intended purpose of, or indications for, the device, as they appear on the device’s label or primary packaging, as appropriate to the device;
  4. a list of ingredients for the device, where relevant;
  5. the requirements specified in the following table in relation to the type of device specified:

Type of device

A device for which are no health warnings     

Requirements:

One of the following statements, as appropriate for the packaging of the device, prominently displayed or communicated:

(a) ALWAYS READ THE LABEL; or

(b) ALWAYS READ THE INSTRUCTIONS FOR USE

Type of device

A device for which there are health warnings

Requirements:

One of the following:

(a) the following statement, prominently displayed or communicated, followed immediately by information about where the health warnings can be found:

THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE WARNINGS BEFORE PURCHASE; or

(b) both of the following, prominently displayed or communicated:

 (i) one of the following statements, as appropriate for the packaging of the device:

(A)  ALWAYS READ THE LABEL; or

(B)  ALWAYS READ THE INSTRUCTIONS FOR USE; and

(ii)  the health warnings.

(f)   the required statement mentioned in subsection 13(6) (as applicable), prominently displayed or communicated;

(g)   the required statement or statements mentioned in subsection 13(7) (as applicable), prominently displayed or communicated;

Reference Therapeutic Goods Advertising Code (No. 2) 2018 Part 2 section 12.

An advertisement for a medical device must contain the following:

  • an accurate description of the device;
  • either—
  • if the trade name for the device is available—a reference to that name; or
  • otherwise—a reference to another name for the device;
  • a reference to the intended purpose of, or indications for, the device;
  • subject to subsection (5)—the requirements specified in the following table in relation to the type of device specified:

Type of device

A device for which there are no health warnings

Requirements

One of the following statements, as appropriate for the packaging of the device, prominently displayed or communicated:

(a) ALWAYS READ THE LABEL; or

(b) ALWAYS READ THE INSTRUCTIONS FOR USE

Type of device

A device for which there are health warnings

Requirements

Where the label of the device is visible on the primary pack, one of the following:

(a) the following statement, prominently displayed or communicated:

THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE LABEL BEFORE PURCHASE; or

  (b) both of the following, prominently displayed or communicated:

      (i)  ALWAYS READ THE LABEL; and

      (ii) the health warnings.

Where the device does not have a label visible on the primary pack, one of the following:

(a) the following statement, prominently displayed or communicated:

THIS PRODUCT MAY NOT BE RIGHT FOR YOU. READ THE INSTRUCTIONS FOR USE BEFORE PURCHASE; or

  (b) both of the following, prominently displayed or communicated:

                  (i)  ALWAYS READ THE INSTRUCTIONS FOR USE; and

                 (ii) the health warnings.

Reference Therapeutic Goods Advertising Code (No. 2) 2018 Part 2 section 13

The advertising code has specific requirements for advertising, which are additional to any requirements for label compliance to the Essential Principles and ISO 15223-1. Therefore, to ensure that your device meets the labelling requirements for the Australian Market, all the following should be considered, ISO15223-1, Essential Principle requirements and the Therapeutic Goods Advertising Code (No. 2) 2018.

 

 

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