1/25/2021
The minister’s Advisor and General Director of medical Devices at the meeting of the manufacture of laboratory kits and medical diagnostics kits said

The presence of the first Notified Body Institution in IVD area in Iran / 33 thousand IVD registered in Iran

Date:2/2/2019 6:31:00 PM   |   Code : 3787   |   View: 5221

Dr. Reza Masaeli announced issues at the meeting of producing laboratory products and IVD medical diagnostic kits from the presence of the PCBC Institute as the first active body in the IVD area and certification of compliance with EU requirements in Iran

The presence of the first Notified Body Institution in IVD area in Iran / 33 thousand IVD registered in Iran

Dr. Reza Masaeli announced issues at the meeting of producing laboratory products and IVD medical diagnostic kits from the presence of the PCBC Institute as the first active body in the IVD area and certification of compliance with EU requirements in Iran

According to the Health Ministry Public Relations, Dr. Reza Masaeli, The Minister's Advisor and General Director of the Ministry of Health and Medical Devices said at a meeting of the manufacture of lab products and diagnostic kits in pasteur Institute, said: " The degree of diversity of medical Devices in the world is more than 500 thousand and 280 thousand in Iran, while the diversity of medicine in the world is 20,000 in the world and 3 thousand in Iran.”

He added that the size of the medical Devices market in the world is estimated at $ 430 billion in the world in 2020 and $ 7.2 billion in Iran

Dr. Masaeli pointed out that the increase in exports is one way to increase the market of medical Devices in Iran, as the General Authority for Medical Devices has developed its main purpose in year 2018 of the tenfold increase in medical Devices exports compare to last year

Director General of Medical Devices stated that according to Article 4 of the general policies of the system in the field of health, the establishment of international standards infrastructure is one of the tasks of the Ministry of Health which is therefore receiving CE is required for medical Devices manufacturers

He also said while the Iranian Regulatory Authority had undergone significant changes this year:
"A qualitative assessment of medical equipment includes four basic pillars, including the qualified institution for auditing and establishment of the quality management system, production consultants and companies equal to the Health Ministry" s criteria for evaluating compliance with the European Union " s criteria, associate laboratory and qualified laboratory ISO17025 that tests the performance and safety of the product.”

“With the regulatory relevant institutions such as PMDA and ANVISA posed by the European Union, we have a wide association of cooperation, " Dr. Masaeli added

Director General of Medical Devices on the Growth of the Medical Devices Market in Iran, said: “The growth of the medical Devices market in Iran is about 2 times more than the global average. The average rise in medical Devices in the world is 6 % and 9.1 % in Iran.”

He pointed out that there were 33 thousand items of goods from 280 thousand of medical Devices goods in the field of IVD
89 % of the 33 thousand equipment and laboratory products registered in Iran are imported and 11 % of them are produced
Also 96 % of producing IVD are products and 4 % of them are equipment

“PCBC institution is present as the first active NOTIFIED body member of IVD in issuing certification of compliance with EU requirements in Iran, " Dr. Masaeli said

The General Director of Medical Devices stated that "consulting firms in the field of producing IVD are very empty, which I invite faculty members to act as consultant companies for producing medical Devices in the field of IVD

According to the report, At the conclusion of the meeting, Engineer Roza Mokhtari, head of the department for monitoring the production and quality control of medical Devices, explained the challenges of the IVD area: one of the most important challenges in this field is to change the pattern of diagnostic methods toward more accuracy and interference of human resources , lack of comprehensive laboratory for evaluation of safety and performance of laboratory products, number of IVD technologies, the lack of familiarity of engineering fields with laboratory sciences and the absence of a birth certificate bank

It is to be mentioned that a day of fears and hopes in the production of laboratory products and IVD medical diagnostic kits were held on January 27th-2019 with the participation of the Pasteur Institute, the Center for Biotechnology and the General Authority of Health Medical Devices at the Institute of Health in the Pasteur Institute

Attachment:
Related News:
Your Email Address:  
Recivers Email Address  
 


Poll

http://imed.ir/ENNews/2/3787
Share
Links
  About us
  FAQ
  Site Map
  Contact us

 
Site statistics
 Today Visits 12,455
 ThisWeek Visits 94,950
 This Month Visits 296,292
 Total Visits 11,557,836
user icon
Page Visites:                  1,570,401
Adress

  No.29, Khark St, Enghelab St, Tehran, Islamic Republic of Iran Postal Code: 1415845371

 +98(21)63420            +98(21)66724329

Special link