The Medical Device Code of Ethical Marketing and Business Practice (the Code) governs interactions between signatories and their customers, namely healthcare organisations and healthcare professionals. The Code fosters trust in the medtech industry by creating an ethical framework that protects the industry reputation. All SAMED, MDMSA and SALDA members are bound by the Code and members are also obligated to workshop and communicate the principles of the Code to their employees, agents, dealers, and distributors as it is a requirement that they adhere to the Code.
All Company code compliance officers, ALL customer-facing personnel and any other relevant personnel are furthermore required to be certified on the Code. This is a mandatory requirement for all SAMED, MDMSA and SALDA members. Certification ensures that employees understand the Code and reduces the risk that an employee may transgress the Code which could have reputational or other consequences for the member company.
As the Code has been updated several times since the institution of the online certification, SAMED has updated the associated test to reflect these changes. We, therefore, require all company code compliance officers, customer-facing personnel and any other relevant personnel to be recertified against the updated online test. For some certification has not yet expired, however, it will still be necessary to retake the updated online certification test to ensure compliance with the most recent version of the Code. Once successfully completed, the certification is valid for a period of three years. You will be able to claim 2 ethics CPD points when passing the test.
Vouchers issued by Medical Practice Consulting (MPC), who are the administrators of the online certification, are still valid for the first three attempts. If you are unsure of your voucher number, please contact firstname.lastname@example.org who will assist you. If the user fails to pass with at least 70% within the three free attempts, additional attempts can be purchased at R500 excluding VAT.
The company code compliance officer is required to ensure that all customer-facing personnel and any other relevant personnel at their company have undergone company arranged or other training on the Code and have taken and completed the online certification test.
Annually, company code compliance officers are required to sign a declaration that they have met the above requirements. This is to ensure that the requisite member employees (including new employees) are trained and certified against the Code. Training and certification ensure that employees understand the Code and reduces the risk that an employee may transgress the Code which could have reputational or other consequences for the member company. We require all company code compliance officers to sign the declaration (as communicated via our implementation partners Medical Practice Consulting (MPC)) by the 31 March 2022 deadline.
To ensure that the Code is understood and consistently practised by members and industry stakeholders, SAMED has developed guidance and training materials that describe and explain the key principles of the Code and their intended application. These materials are available for in-house member company training and covers inter alia, compliant company events, provision of promotional items, gifts and competitions, sampling and demonstration products, charitable donations, loaned equipment, rebates, royalty arrangements, reimbursement procedures and advertising etc. We urge all members to adopt policies and procedures to ensure compliance with the Code, which includes, inter alia, mechanisms to ensure that all events, sponsorships, marketing, and advertising campaigns are signed off by the company code compliance officer