Medical devices and equipment sector is one of the sectors which increased its external trade and production capacity very quickly in recent years.
Considered among advanced technology sectors, medical sector makes innovations in its product portfolio in parallel with its fast improvement in the last years. Even though local production, research and technology is not at desired level, new product manufacturing capacity of the sector is increasing day by day.
Having a constantly increasing product diversity, medical sector covers following product groups: medical imaging systems and devices, operating room devices, respiratory equipment, surgical devices and equipment, dentures, catheters, cannulas, furniture and accessories used in surgery and dentistry, other artifical parts of body, electro diagnostic devices, ozonotherapy, oxygen therapy, other therapic devices and accessories, furniture used in dentistry, mecanotherapy, massage, psychotechnics and test devices, dentistry-specific devices and equipment, sterile catguts, similar sterile suture materials and hemostats, devices and equipment used in eye surgery, dentist lathes, medical/ surgical and laboratory sterilizers, x-ray devices and artificial joints, prosthesis and orthesis, sound and hearing instruments, optic medical devices, disposable consumables, radiotherapy systems, physical therapy devices, biochemistry, molecular biology, hematology, genetic and microbiology devices.
Product range manufactured in Turkey are: stone breaker devices, operation tables, operation lamps, anesthesia devices, bed-side monitors, electrocautery, gynaecologic tables, surgical aspirators, oxygenation devices, x-ray devices, steam and dry air sterilizers, bloodletting chairs, medical gas systems, centrifuge, mixers, patient beds, stretchers, dentist units, hardware and software for hospital information system, surgical equipment, tubing set used in heart and vein surgery, cardioplegia sets and cannulas, drainage tubes, intracet, stent, catheter and probes, blood pressure transducers, i.v. set, blood and blood products, bloodletting and blood transfusion sets, blood bags, operation and examination gloves, suture yarns, operation clothes, catgut, gauze bandage and cotton, orthopedic prosthesis, orthopedic repair materials, x-ray bath solutions, repair materials for dentistry, syringes, injections, medical masks, incubators, centrifuges, water distillation devices, blood keeping refrigerators, climatic test cabins, elastic bandages, bio carriers, defibrillator, hydrophilic urinary catheter, surgical sutures and serum sets.
In Turkey, number of companies operating in this sector increased in the last years. Yet, number of companies conducting production and export is still limited. Sector representatives state that there are approximately 6000 companies in medical sector and that more than 2500 companies among them are suppliers. Approximately 100 companies of 450 middle and big sized companies of the sector are producers and exporters. They conduct their production operations with a wide product range. These companies are generally in İstanbul, Ankara and İzmir. Yet, medical product groups have been started to be produced in other cities as well, including Samsun.
Medical sector of our country gained momentum with improvement of Turkish health sector, increase in the number of new and private hospitals, increase of quality health service demand, technological innovations and other factors. Companies operating in the medicalsector in Turkey plan to establish their own quality systems and to have them certified in order to meet customers’ expectations, improve their efficiency, be successful within EU harmonization process and to establish legal requirements. TS EN ISO 13485 standard is an international standard which covers quality management conditions for medical devices. Established on the process model of ISO 9001: 2000 standard, TS EN ISO 13485 iscompatible with other management systems including TS EN ISO 14001 and TS 18001 (OHSAS). TS EN ISO 13485:2003 standard was preparedto replace TS EN ISO 13485:2002 and TS EN ISO 13488:2002 standards.
It is observed that most of the companies in the sector carry CE mark together with this standard. In addition to GMP and GHP standards, it is also observed that there are certain companies in Turkey which hold FDA and TGA certificates which are required by countries including USA and Austria.
Strong and weak sides of Turkey in medical devices, materials and equipment sector& threats and opportunities
1.Our country has a young, crowded and dynamic population willing to use information technologies.
2.Communication infrastructure of our country is new and modern.
3.We have universities with high education quality.
4.There are companies which produce medical devices, equipment and materials even though they are small scaled.
5.There is a qualified and quality manpower in our country and their fees are relatively low.
1. Medical devices and equipment are usually imported.
2.Biomedical engineering services are insufficient with regard to maintenance, repair and calibration of current medical devices and equipment.
3.Production of local medical devices, equipment and consumables is insufficient (about 15%).
4.Production is conducted at certain regions and in limited amounts, high foreign-dependence in terms of semiproducts or raw materials. Prepared by: Fatih Saraç.
5.Current medical devices and equipment are not used efficiently, unnecessary or improper devices are purchased because of lack of planning and coordination.
6.Supervision is not appropriate and sufficient with regard to the production, certification, sale and import of medical devices and consumables.
7.Research& Development studies related to the sector are not sufficient because of weakness of universityindustry relations.
8.Employment and personal rights of user personnel are not sufficient.
1. In case Turkey becomes a member of the European Union, independent technological improvements might be restricted.
2. Employment and personal rights of user personnel are insufficient.
3. Users don’t believe in local producers and local products.
4. Convenient job and pricing opportunities are few. In addition, competent and qualified people seek going abroad or they become obliged to work in another area.
1. Turkey participated in 6th and 7th frame program of the European Union, therefore Turkey will be able to cooperate with companies and universities in European countries with regard to research & development, and our country will be provided with financial resources in this regard.
2. Our citizens who are working abroad and who are specialists in their fields can contribute to the sector directly or indirectly.
3. There is a market potential with a local and natural volume as a result of our young, dynamic and crowded young population.
4. Qualified manpower is available in medical devices and equipment sector to design new technologies.
5. There are few companies that produce medical devices, materials and equipment, which have knowledge in this regard.
6. Fields such as bioengineering, biocompatibility, tissue engineering are still open for improvement for foreign countries.
7. There is the opportunity to utilize from investments made in defense industry, and companies which conduct high technological production.