SAMED YEAR END NEWSLETTER

December 2017

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Index Message from our Chairperson Page 03 SAMED 2017 Events Page 04 Special Thanks Page 08 Welcome to new members Page 08 Industry Movers and Shakers Page 09 SAMED Committee Round-up Page 09 SAMED’s Global Partnerships Page 15 Association News Page 18 CRICE Page 19 SAMED Salary Survey 2017 Trends Page 20 Industry News Page 21

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Message from our Chairperson

The Code Committee, took up an incredible challenge upon our exit from the Marketing Code Authority and handled the crossover extremely effectively and professionally. My grateful thanks to every single person who serves on the Board and all committees as well as the SAMED staff who have dedicated their time and resources to assist wherever required.

A special welcome to our new staff members, Taz Gabriel and Vuyisani Bill.

May I wish all our members a safe and festive holiday season. Rest well because if you think 2017 was tough, 2018 is sure to be tougher!

Vuyisani has a degree in media studies and is currently doing her Hons focusing on gender representation in the South African Media. She was previously at the South African Medical Association running the Limpopo Branch.

Taz has a marketing based background, starting her career in Commercial marketing with Standard Bank. She transitioned into Pharmaceuticals in 2011 doing marketing for Pfizer and Sandoz Novartis.

Taz Gabriel:

Project officer

As I have been restricted in the number of words I may use, I only have the ability to recognise a few achievements. 2017 has been an interesting and challenging year. Whilst I don’t want to take away from any of the volunteers that work to further the goals of SAMED, it would be remiss of me not to acknowledge two committees in particular. The Regulatory Committee, has worked tirelessly to ensure that the regulatory environment is one that will be palatable for both industry and the regulator. To this end we have raised our profile dramatically with key stakeholders in the National Department of Health.

Vuyisani Bill: MDMSA Secretariat

& SAMED Office Administrator

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SAMED 2017 Events

Dr. Joey Gouws - Registrar of Medicines, MCC

This year, SAMED held 24 member events, with over 1000 attendees. These included regulatory forums, general member meetings and our flagship Annual Conference. We encourage you, our Member’s to attend these events. We try our best to tailor the topics and speakers to the business needs of our members and we do hope you find them of value. Herewith are some pictures from our events that have occurred during the year.

SAMED Global Medical Device Nomenclature Workshop – February 2017

Dr. Barry Daniels – Technical Lead, GMDN Agency

SAMED/Gauteng Health Medical Device Procurement Seminar – May 2017

Some of our speakers in the audience including

• Andrea Julsing Keyter – Medicines Officer, MCC

• Malakia Mashiloane - Chief Director: Supply Chain and Asset Management, NDOH

• Dikeledi Tshabalala - Chief Director: Supply Chain Management, NDOH

• Manthepeng Tshinavha - Director: Transversal Contracting, National Treasury

Panelists on stage including:

• Marlon Burgess – SAMED

• Prof. C Househam – SAHPRA Board member

• Malakia Mashiloane - Chief Director: Supply Chain and Asset Management, NDOH

• Dr. S. Maseko – CEO Chris Hani Baragwanath Hospital

• Dr. N. Mtshali – CEO Bertha Gxowa Hospital

• Tabisa Majaja – DDG: PSCM, Gauteng Treasury

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SAMED’s flagship event, our Annual Conference was held at the end of August. With the theme ‘Advancing Quality in Healthcare’’ and attended by more than 200 delegates over both days, the event was highly regarded.

Herewith some speaker highlights:

Gavin Steel of the National Department of Health who did the opening address at the Conference. He is pictured here with Rob Millar of SAMED

In remembrance of Kurt Worrall-Clare pictured here with Tanya Vogt of SAMED

Dr. S. Maseko of Chris Hani Baragwanath Hospital and Dr. T. Moodley of SAMED

SAMED Annual Conference – August 2017

SAMED Code Launch – June 2017

Dr Joey Gouws – Registrar, Medicines Control Council urged industry to engage in dialogue and feedback so that together, best practices and solutions within the regulatory environment can be created. “For this to happen there needs to be good faith between the Regulator and industry” said Dr Gouws.

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Andrea Julsing Keyter – Deputy Director Medical Devices, Medicines Control Council listed processes hospital procurement officers need to be aware that:

• Registers of all implants need to be kept – which patient was implanted with what device, from which supplier and manufacturer

• Facilities require a certified technician who can maintain and service devices and show records of maintenance

• Channels for adverse event reporting to the Registrar need to be used so as to promote patient safety

Roeland van Aelst – Regional Vice President, HCCO MD&D EMEA, Johnson & Johnson Medical stressed the purpose of the MedTech Europe Code.

Such a code aims at ensuring that all interactions between companies and Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs), such as hospitals and clinics, are ethical and professional at all times, so as to maintain the trust of regulators, and – most important of all – the patients.

Conference delegates during the networking break

The Conference organizing team From left to right

• Tanya Vogt

• Vuyisani Bill

• Nicky Tamboer

• Sharon Dore

• Taz Gabriel

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And feedback from the Annual Conference attendees:

“This year the SAMED conference was just amazing, it provided all that a conference should deliver and more. From the thought provoking dialogues between different stakeholders to the highly specialized debates with industry experts on the future of healthcare in South Africa. It definitely is established as a world class think tank forum for the healthcare sector. “The theme “ADVANCING QUALITY IN HEALTHCARE” was exactly what I felt was achieved by allowing a platform to share best practices between private and public sector whilst contrasting on valuable lessons learnt through their experiences. The panel discussions where very intimate and allowed everyone to have their opinion heard and to have constructive debates about the role of the private sector as a stakeholder in NHI. The cloud of uncertainty was addressed by involving decision makers in policy with industry stakeholders to engage in depth on the changing landscape of the Healthcare sector, new regulatory environment for Medical Devices and the transforming Public Procurement systems.”

“This year’s conference was very valuable with all of the new developments happening in the Industry. It served me greatly in planning my way forward”

“My favourite highlight was on the debates on

the role of developing good governance and

leadership needed from all stakeholders to

ensure that we work better together. I was

captivated by the sheer commitment that all

participants had to make our healthcare system

great, to deliver the best quality healthcare to

South Africans as that forms the foundation of a

great nation. The willingness to open up and

invest resources, time and intellect towards

resolving societal ills so that their contribution to

the sector is meaningful and has a greater

impact. As a government employee I am very

encouraged by SAMED and all its members for

the amazing conference and initiative towards

developing managerial and leadership capacity

in the healthcare sector for it is the missing

catalytic ingredient to transform and deliver

quality to our people.”

“Good governance will not result from a mindless quantitative compliance with a governance code or rules. Good governance involves fairness, accountability, responsibility and transparency on a foundation of intellectual honesty.” Quote from the Mervyn King book ‘The Corporate Citizen’. I want to congratulate SAMED for giving meaning to this quote by actively working at promoting ethical principles and practices in the healthcare sector. Keep up the good work. We eagerly can’t wait for the next conference to learn more and develop better’.

SAMED HTA Workshop – November 2017

Dr. N. Nematswerani presenting on Discovery’s HTA process

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Special thanks One of our major operational costs is hosting events. We wish to thank the following member companies for their support in offering their facilities in this regard:

2017 saw the following companies join SAMED. Welcome.

At last count, SAMED membership included: 171 Ordinary members 16 Associate members 3 Association members Please visit www.samed.org.za for a full list of SAMED members

❖ Abex Pharmaceuticals ❖ Allenco Medical ❖ Barc Development ❖ Batho Pele Healthcare ❖ Betta Dental Supplies ❖ Biofourmis SA ❖ Cerdak ❖ CircumQ IP ❖ Concare Health and Medical ❖ Coopers Africa ❖ DBMed Suppliers ❖ Dr Temp ❖ EthiTech ❖ Guerbet SA ❖ HASS Southern Africa ❖ Hi Care Surgical ❖ ImpactRx ❖ Infection Protection Products ❖ Kiara Healthcare ❖ Klinikka

❖ LDK Intertrade

❖ Lifescan ❖ Ligamed SA ❖ Med-El Implant Systems ❖ Mezotrix ❖ New Age Medident ❖ NGL Africa ❖ PSG Medical ❖ Rudolph-Shortt Consultancy ❖ Sea 4 Medical ❖ Sure Medical ❖ Surgical Navigation

Technology ❖ Tshelang Medical ❖ The PharmaWorld ❖ Thusanang Enabling Support ❖ Unitron SA ❖ Vortex Medical ❖ Zebra Medical

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Avanthi Govender Bester SALDA / SAMED Africa Forum Chairperson

SAMED Committee Round-up

One of the SAFMED founding Directors, Pat Ayling, has taken the decision to retire at the end of the year. Pat has been a past director of SAMED and played an invaluable role in support of local manufacturers. SAMED wishes Pat the very best for his retirement.

SAFMED’s General Manager, Rehana Ellahi, has been promoted to Managing Director and is now a Shareholder in the Company.

Stacy Meyer has been appointed General Manager for the

Johnson & Johnson Medical Devices business in South Africa,

effective 11 September 2017.

In her new role, Stacy will be responsible for leading the South

African team in ensuring that the Patient is at the centre of all

decisions and executing the commercial strategy for the

Medical Devices portfolio in South Africa to deliver growth. She

brings strong leadership to this role, coupled with sound

understanding of the global healthcare landscape and driving

value for patients.

Industry Movers and Shakers

Instead of having a committee structure with meetings, we created the Africa Forum. The Africa Forum meeting is held every two months, typically with an RA Forum meeting. This has allowed for wider member participation without the need to attend a separate event.

This year we changed the way we communicate on the developments of our Industry on the African continent.

Pat Ayling Rehana Ellahi

Stacy Meyer

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Rob Millar Code Committee Chairperson

Some of the highlights for this year: Kenya – reintroduction of the compulsory PVOC program. Tanzania – roll-out of general medical device and IVD registration with the TFDA. We focused on different regions for the Forum discussions and also included a guest speaker with expertise in doing business in the SADC region. As we look to 2018, we will continue with the Forum structure, and regional focus. We are aware that with South Africa implementing regulations, other African countries will not be far behind in this process. We continue to maintain the African data base that provides members with updated information on the various contact people for the different countries in Africa.

On the 27th and 28th November 2017, we participated in the 3rd Biennial Scientific Conference on Medicine Products Regulation in Africa to be held in Accra, Ghana. On the 3-8 December 2017, we will be participating in the AHWP Conference in New Delhi, India. Both events will provide a lot of useful information on the developments and implementation planning for the regulation of our products in the various countries in Africa. We look forward to sharing this information with you at the next Africa Forum meeting to be held early in 2018.

The Code Committee has established three working groups dealing with:

• Training and Certification Process

• Indirect Sponsorships

• Payment of product support fees to Private Nurse Practitioners

The Training and Certification Group has made good progress in developing the contents for an online certification test which will enable Members to certify on the Medical Device Code of Business and Marketing Practice. It is intended that the online test will go live in mid January 2018 and the certification will be valid for a period of three years before renewal is required. Members will not have to pay for the test, however if you fail the test three times then the fourth try will cost you R500. So make sure you read the Code and any other supporting documentation before you take the test.

The Indirect Sponsorship Group has been given the task of convening the various role-players to identify what processes are to be implemented regarding the selection process under the Indirect Sponsorship implementation which becomes effective January 2019. Workshops will be held for Member companies, Professional Conference Organisers and Medical Societies. SAMED has taken the decision to outlaw the payment of product support fees to Private Nurse Practitioners – but before implementing the decision, it is necessary that a study into the practicalities of, for example, would care management and reimbursement levels be undertaken. Modalities such as stoma therapy and diabetes care will also be investigated. It is imperative that patients continue to receive adequate treatment.

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Marlon Burgess Government Procurement Committee Chairperson

Key Objectives 1. Ensure SAMED members are paid

timeously by the public sector 2. Address SAMED member issues relative to

National and Provincial department of Health tenders

3. Engage stakeholders at all levels to improve public sector payment and procurement processes

Vision for 2017-2018 SAMED members are paid on time and SAMED member complaints about tenders are minimized. Recent achievements In 2017 the Government Procurement Committee made tremendous strides in terms of stakeholder engagement. In May 2017, the committee hosted a seminar with the Gauteng Department of Health on Best Practices in Medical Device Procurement. Over 100 delegates, including supply chain management and clinical heads, from various Gauteng health institutions attended the workshop, which was a great success. Meetings were held with key stakeholders like the Department of Performance Monitoring and Planning (DPME), National Treasury, KZN and Western Cape DoH, Gauteng MEC Barbara Creecy, and the committee chairman, Marlon Burgess, presented at the Africa Health Congress on the MEAT (Most Economically Advantageous Tender) initiative adopted by the European Union.

The SAMED POET (Procurement Officers Education Trust) initiative was presented to the DG for Health, Precious Matsotso. SAMED members can support the committee’s activities by volunteering staff with the pre-requisite skills and knowledge of government processes to join the committee, as our workload has increased tremendously. Members should allocate a dedicated staff member to navigate the complex relationships between government hospitals, provincial and National Departments of Health and provincial and National Treasury. Most importantly, companies should attend SAMED workshops and read the extensive information communicated by the SAMED office! Outstanding payments As a result of our monthly outstanding payments submissions to the DG of Health, the Northwest Provincial Department of Health, the Limpopo Department of Health, the KZN Department of Health and the Western Cape Department of Health have made a request for our member companies to make submissions for outstanding payments directly to them. These Provinces have started paying the member companies who have provided them with all relevant documentation.

Tanya Watson Health Economics and Reimbursement Committee Chairperson

The Health Economics and Reimbursement (HE & R) Committee had a number of strategic objectives for 2017. Some notable achievements and work in progress include:

• SAMED has requested that the Council

for Medical Schemes(CMS) annual

review data include medical devices

separately so that the spend on medical

devices and equipment can be identified

• An industry market survey is proposed

for 2018 and members are encouraged

to heed the call for participation

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• An HTA Workshop for members with Private Funders and Private Hospital Groups was held on 15 November

2017, and included the purpose of the Nappi coding system

• Two of the committee’s members were nominated to sit on the CMS PMB Review task team. Well done to Pria

Naidoo and Mark Brand

• Another committee member, Bulelwa Maponya, sits on the PMB code of conduct task team

The committee is grateful to these individuals for flying the SAMED flag high!

Clive Potter Orthopaedic Suppliers Committee Chairperson

Pria Naidoo Mark Brand Bulelwa Maponya

The Orthopaedic Suppliers Committee was reconvened this year to continue the work initiated by the Orthopaedic Special Interest Section (OSIS) committee last year. The prime objective of the group is to arrange a quarterly forum for all orthopaedic supplier companies in the elective orthopaedics, trauma and spine business to raise common key issues and concerns within the South African industry. Where appropriate, this committee will also interact with key stakeholders including private hospital groups, funders and the SAOA on behalf of SAMED. The past few years have seen significant changes in the medical device industry as a whole.

This has required companies to rapidly upskill their staff on a variety of new topics and regulations. The key focus of the Orthopaedic committee this past year has been as follows:

• To make our members aware of the

impending introduction of Global Fees for

Orthopaedics and the input from

stakeholders in this regard

• To discuss the proposed changes in

Healthcare Compliance particularly around

sponsorship of HCP’s

• To understand the requirements of the

Loan Set standard (SANS 1541) and to

ensure that our members are updated

Regarding NHI, the committee is busy reviewing the White Paper and will be asking for a workshop with the National

Department of Health to discuss areas requiring clarity. It is noted that as we approach the full implementation of

the NHI, HTA will become a key aspect of its achievement. We therefore encourage SAMED members to ready

themselves and consider taking the Post Basic Course in Health Technology Assessment run by the University of

Stellenbosch. Contact Nazreen Abrahams on 021 938 9201 if you are interested in attending this course.

The committee is also keeping a watching brief on the health market inquiry.

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• To interact with the SAOA to investigate the possibility of one single consolidated orthopaedic congress

meeting in 2018 or 2019.

Clearly, this is just the beginning of several initiatives and interactions which this committee plans to implement and address over the coming months. We look forward to a productive and challenging year ahead!

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Madeleine Pearce Regulatory Committee Chairperson

The SAMED Regulatory Committee core working group of 20 meet monthly to progress the following strategic objectives:

• To proactively influence and drive for appropriate regulations by engaging with stakeholders and consumers of our products

• To provide SAMED members/stakeholders with direct knowledge of industry and international trends and developments

Medical Device Establishment Licenses When the South African National Department of Health mandated the Medicines Control Council (MCC) to regulate medical devices, every company that manufactures, imports or distributes medical devices was required to apply for an establishment licence to the Regulator by the 24th August 2017. The SAMED Regulatory Committee has worked intensively to help member companies via its monthly regulatory forums to understand the licensing process and meet the requirements. South African Health Products Regulatory Authority (SAHPRA) now in law Medical device regulations in terms of Act 101 (as amended) were published on 9th December 2016, and on the 1 June 2017, Act 72 (the amendment Act) was enacted, which introduces a new authority, SAHPRA, as the official regulator of health products - after the first meeting of the SAHPRA Board. The timeframe for this is not yet clear, and governance remains with the MCC until further notice.

SAMED is very pleased to announce that Professor Craig Househam, a SAMED nominee has been appointed to the SAHPRA Board. Regulatory Issues As the regulatory framework for medical devices is new to our previously unregulated industry, there were several issues raised with the Registrar (in industry workshops and correspondence and via various meetings with the industry task group, ITG), the Head of Council, the Deputy DG in the National Department of Health, and the Medical Device Expert Committee of the MCC. Committee members met with representatives of the Regulator in the ITG Medical Device Working Group to find alignment with discrepancies and unintended consequences of some of the requirements in terms of the regulations. When hospital groups questioned the supply of some of products in this emerging regulatory environment, SAMED Board Members also participated in raising issues to government. A summary of the issues raised were:

• Disparity between Act, Regulations,

Guidance documents, Position statements

• Section 21 regulatory pathway for

unregistered medical devices

• Communication of medical device

regulatory requirements to industry

• Registration of sub-sites and appointment of

Authorised Representatives

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• Requirements for labelling and definition of

manufacturer

• Rebranding of medical devices that are

imported by more than one entity

• Conflict of interest with consultants to

government and industry

• Requirements for wholesaling license

Keeping SAMED members informed

The SAMED Regulatory Committee has held

regular Regulatory Forums to help members

understand the new requirements. We offer

support and raise issues with the intention of

facilitating a practical and effective regulatory

environment for both the industry and the patients

and clinicians we serve.

Newly published Guidance documents

The MCC has published several guidance

documents on various topics, which will impact

businesses. Where we have the opportunity to

make submissions, the Committee is working to

collate comments for the best possible outcome for

all stakeholders in the South African healthcare

system.

Guidance documents currently in focus are:

1. Recall & Vigilance

2. Classification of Medical Devices

3. Access to and control of medical devices

& IVDs

4. Medical Device Quality Manual

5. License to act as a wholesaler of medical

devices and IVDs

The Chair would like to thank the committee

members for the considerable amount of time

invested in voluntary work done to advance the

objectives of the SAMED Regulatory Committee.

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SAMED’s Global Partnerships

SAMED is supportive of harmonization of ethical and regulatory requirements within the area of Medical Devices manufacture and supply; and to this end engaged with a number of international agencies this year.

Global MedTech Compliance Conference (GMTCC) held every year brings together device and IVD industry regulators, compliance professionals, legal counsels, senior executives and industry observers to analyse and discuss emerging trends in healthcare compliance and recent challenges and to formulate approaches to effectively manage compliance on a global scale.

Delegates in session at the GMTCC

Tanya Vogt (SAMED Executive Officer) with Canadian, Brazilian and Italian delegates

Tanya Vogt, SAMED Executive Officer attended the GMTCC in Amsterdam in May 2017 and brought back key information for use by the SAMED Code Committee in terms of alignment with the Medtech and other international Codes of Practice. SAMED, through its close working relationship with both Medtech Europe and Advamed accessed support documentation, which it is adapting for the phasing in of the prohibition of direct sponsorship of HCPs to third party arranged educational events.

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The Global Medical Technology Alliance (GMTA). Tanya Vogt, SAMED Executive Officer sits on the Board of the GMTA, a forum of trade Associations, who also give input to the International Medical Device Regulators' Forum (IMDRF), where standards of practice for regulation are decided. SAMED has adapted for its own use a number of GMTA position papers to support its position on key medical device matters. The GMTA has WHO official recognition status and has identified key objectives which it shares with WHO, in the following areas: 1. Promoting ethical codes of conduct for the

providers and manufacturers of medical devices for promotion and procurement, in order to reduce corruption and improve procurement practices for the betterment of patient access to affordable medical technology;

2. Promoting good tendering practices and increase the quality and affordability of health technologies in tendering processes by reviewing draft technical specifications of medical devices prepared by WHO, helping to ensure that the specifications do not favour any one provider, increasing transparency, and making use of best practices (for example, as developed by the World Bank);

3. Encouraging the transfer of technologies for development of medical technologies for low-resource settings;

4. Supporting the strengthening of data related to the use of medical devices by encouraging GMTA members to participate in WHO surveys on technical information on available medical devices in the market to target specific priority diseases;

5. Promote the safe use of medical devices through compiling and distributing material and training for health care professionals through the GMTA member associations on the safe use and proper disposal of medical device, participating in, and contributing expertise to, WHO meetings and conferences on specific areas organized by WHO.

SAMED is also a member of the Asian Harmonisation Working Party (AHWP), a non-profit organization whose goals are to study and recommend ways to harmonize medical device regulations in the Asian and other regions and to work in coordination with the IMDRF, APEC and other related international organizations aiming at establishing harmonized requirements, procedures and standards.

This year Madeleine Pearce (SAMED representative) and Avanthi Govender Bester (SALDA representative) attended the 22nd Annual AHWP meeting in New Delhi in December.

Other AHWP member countries include: Abu Dhabi, Brunei Darussalam, Cambodia, Chile, Chinese Taipei, Hong Kong SAR, China, India, Indonesia, Jordan, Kazakhstan, Kingdom of Saudi Arabia, Republic of Korea, Laos, Malaysia, Mongolia, Myanmar, Pakistan, People's Republic of China, Philippines, Singapore, South Africa, State of Kuwait, Tanzania, Thailand, Vietnam, Yemen

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Association News

Anton Coetzee MDMSA Chairperson

William Hodson MISA Chairperson

MDMSA, an associate member of SAMED, is the industry representative for the South African Medical Device Manufacturing sector. Our mission is to grow the industry and develop the capacity of the local device manufacturers. To accomplish this objective set by MDMSA in 2016 the Association found it essential to encouraging more involvement from local manufacturing companies through an increased membership, to ensure better marketing of the capabilities of local manufacturers and their products, to ensure effective representation and advocacy of the interests of local manufacturers in negotiations with stakeholders such as government, and facilitating attendance at health and medical device congresses. MDMSA had two-member meetings in 2017. One in March and another in May. These meetings are an essential part to ensure that the membership is informed about the developments in the industry and within the association. These meeting serve as a platform for members to engage with the elected office bearers of MDMSA, table the challenges and concerns they face with in the industry and interact with other members.

In 2017 MDMSA participated in the Africa Health and Arab Health Conference, we were able to take along 13 local manufacturers to Africa Health and 19 to Arab Health. This participation has opened up new markets for our members and has given them access to international contacts. We are proud to announce our partnership with Informa for the one day procurement conference which is planned as part of the Africa Health 2018 Congress. MDMSA has signed a funding and collaboration agreement with SAMRC – the objective of this Project is to grow the local Medical Device Innovation and Manufacturing ecosystem through information strengthening, collaboration and alignment of stakeholder networks. SAMRC has awarded MDMSA funding to a maximum of R204 000.00 for the project. An application has been submitted to the DTI for further funding. We look forward to an exciting and vibrant 2018!

MISA Medical Imaging Systems Association

SORSA (Society of Radiographers of South Africa) is a non-profit professional voluntary association for Radiographers, the primary operators of the MISA members diagnostic imaging systems. It represents Radiographers in all four radiographic disciplines: Diagnostic, Nuclear medicine, Radiotherapy and Ultrasound. The society which was established in 1951 actively encourages continued professional advancement of radiographers, and to facilitate this, they hold a congress every two years in conjunction with the RSSA (Radiological society of South Africa).

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Robyn Howes SALDA Chairperson

In the diverse medical and healthcare industry of South Africa, the CRICE programme continues to be a sterling example of cross-sectoral collaboration in the interest of the wellness and safety of patients we all ultimately serve. CRICE continues to expand with 427 companies participating to date and 8090 enrolments nationally. The CRICE web platform, www.crice.co.za is an excellent resource for companies to find out more about the programme and to make use of the nifty tools to determine the level of access required as well as check the CRICE status of staff. In January 2017, CRICE transitioned to a fully electronic system using a smart digital signature facility. A new credit card payment system has just been added to the CRICE platform allowing for a smoother online process from enrolment until issuance of the CRICE Card. To register for the CRICE Programme, please visit www.crice.co.za

The CRICE Programme is a centralised national verification programme for Company Representatives who enter the Clinical Environment in South Africa

It is a SAMED initiative administered by Masoom Training Solutions.

This year the congress was held at the ICC in Durban, on 3-5th November, with some of the highlights of the program including a musculoskeletal, Ethics and adult fractures courses. Tanya Vogt, SAMED Executive Officer presented an update on the Medical Device Code of Ethical Business and Marketing Practice. MISA (Medical Imaging Systems of South Africa) has supported SORSA since 1990, by sponsoring deserving Radiographers to attend the congress. The sponsorship takes the form of an indirect sponsorship whereby SORSA selects deserving radiographers whom would receive support to attend.

The Southern African Laboratory Diagnostic Association (SALDA) is a body that represents laboratory medicine in South Africa. It is a single voice around IVD’s. It is a collaboration of 42 members representing multinational and local companies which distribute In Vitro Diagnostic tests. We are constantly identifying the value of the IVD Industry to keep our industry relevant to our market and to promote cost savings for all patients through new and innovative technology. This year we have seen the Medical Device and IVD regulatory process come to fruition. The MCC has called for Medical Device and IVD licensing. SALDA/SAMED have been hosting monthly regulatory forums to inform our members on how to engage with the licensing process. SALDA continues to engage with the invited members of the Laboratory Medicines Group which hosts members of the pathology industry which tackles issues such as training capacity and academic congresses.

Regular meetings with the NHLS Health Technology Assessment Unit and SALDA has resulted in greater co-operation and understanding of the challenges in our common goal to ensure safe, effective and quality testing for patients. The SALDA/SAMED Africa Committee remains one of our flagship information sharing platforms which helps our member to understand the regulatory environment of doing business in Africa. Our goal in 2017 has been to set up and complete a working database of all government and regulatory authorities in East, West, South and North Africa. Our goal for 2018 is to attract more members from the other Sub-Saharan countries, in hopes that we can promote harmonization in the whole African Region. We still face challenges in terms of harmonization policies around Point of Care Tests, and are looking forward to the pending National Policy for guidance. 2018 will continue to be a busy year for us all and we look forward to our engagement with all stakeholders to identify SALDA’s key focus relating to NHI, over the next 5 years.

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SAMED Salary Survey 2017 Trends

PERCENTAGE OF ORGANISATIONS THAT AWARDED INCREASES IN SALARY WITHIN CERTAIN RANGES FOR PERIOD UNDER REVIEW

AVERAGE SALARY

INCREASE RANGE

Employee Category

Executive / Top

Management Management

Professionals / Junior

Management

Client Services /

Sales

General Admin / Technical / Support Staff

Lower Level Staff

All Staff

4.1% to 6% 22 27 27 22 27 20 22

6.1% to 7% 36 40 39 43 40 47 43

7.1% to 8% 21 7 - 7 - - 6

8.1% to 9% 7 7 7 7 7 - 5

9.1% to 10% 14 13 13 14 13 20 15

10.1% to 11% - - 7 - 13 13 6

11.1% to 12% - - 7 - - - 1

12.1% to 14% - 6 - 7 - - 1

Over 14% - - - - - - 1

AVERAGE INCREASES GRANTED DURING THE PERIOD 2016/2017 ARE:

Annual Percentage

Increase in Basic Salary

Annual Percentage Increase in Guaranteed

Pay

Weighted Average Increase per Category

ALL STAFF 2017 6.8 6.7 6.7

ALL STAFF 2016 7.0 7.1 7.1

The table above illustrates the downward tendency in salary increases from 2016 to 2017.

Key trends from the 2013 SAMED Salary

Survey which is subsidized by SAMED This is the 16th year that SAMED has conducted its annual Salary Survey for Members benefit. 31 SAMED Members participated this year. We urge members to consider participating as the benefits are significant. The more participants the greater the value to all. Results become more representative of the industry as a whole. The survey covers approximately 76 positions (across all regions of South Africa) from Junior to Executive positions. Market benchmark salary tables are reported in market quartiles incorporating Basic salary, guaranteed package (inclusive of Benefits paid) and Total Cost of Employment.

Current and projected salary trends (inclusive of projected increases, together with commentaries pertaining to the South African Medical Device market, are included.

This year’s results confirm that 94 per cent of the SAMED Member participants review salaries at set times each year with the most popular review months being March, April and December.

Some key findings include: Average salary increases were about 1% above the average inflation rate of 5.62% for 2017. Average actual increases granted to each employee category during the period under review (October 2016 to September 2017) are summarised below.

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Industry News

The SMART Group is delighted to announce that it is now part of Intellectus Campus, an affiliate of Avacare Global. The acquisition of The SMART Group by Intellectus Campus provides exciting expansion opportunities for the united company and our dedicated team of trainers with Smart bringing expertise in healthcare training and Intellectus expertise in virtual training, a growth medium Smart has long wished to enter.

Effective 1 August 2017 Condor Medical Africa (Pty) Ltd will trade as Meril Cardiology. Meril SA (Pty) Ltd acquired the full shareholding of Condor in February 2017 and as a 100% subsidiary we have decided that we need to align with the parent brand and become Meril Cardiology. Meril SA (Pty) Ltd currently has two other verticals trading in South Africa, namely Meril Orthopaedics and Meril Endo-Surgery. We thank you for your continued support in the field of Interventional Cardiology.

From all of us here at SAMED

The plant formerly known as Roynhardt, in existence for 25 years was relocated to Cape Town and underwent a major upgrade between March and August 2017. This included a water processing plant to produce water for humidification and also consisted of installing 3 new clean rooms from class 9 to class 7, which were commissioned in July. The 4 PVC and 1 silicon extruders were refurbished, resulting in a 40% increase in output and a 75% reduction on materials waste. Our ETO sterilizer was delivered in November 2017 and will be commissioned in February 2018. We are currently in the process of applying for ISO9000 and 13485 accreditation. In line with the recommissioning of the manufacturing plant, the staff complement has increased to 30 and as we are committed to the meaningful transformation of our workforce and firmly believe in our abilities to find solutions to empower our people, we are proud to have included previously disadvantaged and disabled individuals to form the majority of our wonderful workforce.