Medical Device Code

Professional integrity is at the heart of quality healthcare, and the global
healthcare industry is carefully scrutinised and highly regulated.

There is close collaboration between the medical technology industry and healthcare professionals in utilising technological innovation to improve patient care. Healthcare professionals play a vital part in research and development leading to medtech innovation, and suppliers provide training and service support to health professionals to enable them to use products correctly.

In the context of this mutually beneficial relationship, it is critical to keep sight of the fact that the patients’ interests must always come first. In particular, medtech companies must: (i) respect the obligation of healthcare professionals to make independent decisions regarding patient treatment; and (ii) guard against inappropriate and irresponsible marketing and business practices which could compromise patient outcomes and damage the reputation of healthcare professionals and the industry.

The Medical Device Code for Ethical Marketing and Business Practice governs interactions between suppliers and their customers, namely healthcare providers and professionals. It fosters trust in the medtech industry by creating a framework for ethical activity that protects the reputation of industry stakeholders.

The Code is an instrument for self-regulation of the medical technology industry and SAMED is the custodian of the Code. Its key principle is that signatories to the Code will not offer inappropriate inducements to healthcare providers and healthcare professionals in order to sell or lease their products.

Penalties may be imposed on signatories to the Code if, after a fair investigation and/or hearing, they are found to have transgressed the provisions. This process is triggered by a complaint or tip-off to the Medical Device Code Hotline (free call 0800 00 04 68; email: samed@tip-offs.com).

Download the Code
Download the revised Code Values
View Code Resources

Compliance Officer’s Toolkit

The Medical Device Code for Ethical Marketing and Business Practice (the Code) governs interactions between suppliers and their customers, namely healthcare providers and professionals. It fosters trust in the medtech industry by creating a framework for ethical activity that protects the reputation of industry stakeholders. Each SAMED member is a signatory to the Code through membership and is responsible for appointing a compliance officer who acts as the primary liaison with SAMED and who must ensure that company staff are trained on and adhere to the Code.

In order to support Compliance Officers in their role, SAMED has developed a Compliance Officers Tool Kit with information and resource links relevant to Code training, promotion and certification. We encourage company compliance officers to save the tool kit and make use of the content as needed.

Download the Toolkit

Code Certification

In order to ensure that the Code is understood and consistently practised by members and industry players, SAMED has developed training materials that describe and explain the key principles of the Code and their intended application. These materials are available for in-house training conducted by our members and support our regular training events. Training covers the proper conduct of company events, use of promotional items, gifts and competitions, charitable donations, loaned equipment, bonusing, rebates and incentive schemes, royalty arrangements, reimbursement procedures and advertising.

The Medical Device Code of Ethical Marketing and Business Practice has been updated several times and as such the Online Certification Test has also been updated. Everyone who has been previously accredited needs to be recertified against the updated online test by 31 March 2022.

To complete the Medical Device Code of Ethical Marketing and Business Practice Online Certification, click below. The certification is CPD-accredited and open to medtech suppliers as well as healthcare practitioners. All queries regarding certification should be directed to secretariat@samed.org.za / 011 704 2440

Get certified

Anonymous whistleblowing hotline

Whistleblowing is recognised as the most effective measure to guard against fraudulent or unethical activity within organisations. The Medical Device Code whistleblowing hotline is an anonymous tip-off mechanism- available to any member of the public or SAMED wishing to report contraventions of the Code. The hotline is independently managed and available 24/7.

Contact the medical device code hotline:

  • Free call: 0800 00 04 68
  • E-mail: samed@tip-offs.com accompanied by the completed complaint form.
Download complaint form

List of related reporting mechanisms: