Introduction

 A brief look at Medical Devices Department’s chart

Name of Department

Supervising and Assessing of Medical Devices Department of Food & Drug Organization

A brief Introduction of department (history, and legal bases of department’s formation & its purposes):

Based on system’s law and duties of Ministry of Health, treatment and training, aimed at monitoring medical devices and medical affairs. There was an office formed “medical devices office” in medical treatment deputy in 1984 and then its structure was altered to Department in 1992. Due to the fact that the job was really important, the office was promoted to medical treatment deputy of Ministry 7 health care and It Was in 1998 that started Working under supervision of minister of health deputy, active in the field of commercial affairs and at the same time working with the same person heading management center and coordinating commercial affairs.

In September 2011, food and drug association appeared and the department was separated from, that organization and became medical device supervision & assessing department under Iran FDA.

Based on 11,12,13,17 classes of article of ministry’s duties and note 5 Article 13 and note 2 article 14, and note 2 article 3 concerning medical, drug, edible, and drinkable affairs and clauses 24, 25, 27 of law aimed at combating against smuggling goods enacted in 2013 and based on a by-law for medical devices department enacted in 2006 and revised in 2013; therefore, this department assumes it responsibility to monitor, assess safety quality of medical devices as well as dental , laboratory and granting certificate to applicants concerning activities done in the fields of production, import, export , distribution, and after sale’s services.

 

Purposes and missions in brief:

This department is in a direct contact to address issues such as prevention, diagnoses, treatment, and monitoring and treating diseases with help of medical, dental, and laboratory devices and their role in safeguarding patients’ lives. Elsewhere, this department undertakes to monitor the usage and distribution of high quality, safe, genuine, effective, accessible, reasonable price, for all walks of life.

1. Supervising & assessing medical devices, dental, and laboratory devices at the same time

   granting certificate to applicants in the field of production, import, export, distribution, and  

   providing bill, by-laws, regulations in the mentioned fields and revising them.

2. Planning for assessing and correcting performance of those active in the field of medical

devices.

3. Granting permit and I.D activity to companies active in the field of medical devices

    (Producers, exporters, importers, distributors, and unions)

4. Surveillance on entry & clearance of laboratory, dental, and medical devices, contain:

   .Granting production permits to producers

   . Granting permit to exporters

   . Presenting annual plan for facilitating export by coordination of beneficiary organizations

   . Planning aimed at protecting local manufacturing in line with quality promotion and macro –  

     policies of the country.

6. Surveillance and assessing (inspection) price& distribution, supply, usage, and maintenance of

     medical devices

   . Planning to set and control price in the market

    . Setting market services & products by compiling short- term, long- term, mid- term programs

     in order to price control or prevent.

. Creating competitive atmosphere among suppliers aiming at increasing variety, quality and

   Quantity control and price deduction

  . Surveillance and inspection of distribution net-work in the field of medical, dental, laboratory  

   devices & supplies

7. Surveillance on laboratory, dental, medical devices maintenance

    . Assessing companies after-sales services

    . Organizing data bank of active companies (importers, producers, distributor, unions)

8. Monitoring performance of medical devices offices of medical sciences universities

9. Net-working and informing to exchange information between private & state parts for taking

    business opportunities

10. Studying commercial exchange of IRI and foreign countries in field of goods and health

      products and coming up with executive mechanism in line with maintaining countries

      economy interest

  • The Office of the Supreme Leader, Grand Ayatollah
  • Medical Equipment Administration Telegram Channel
  • Channel Food and Drug Administration
  • Channel Ministry of Health and Medical Education
  • Iran National Trading System Telegram Channel