According to many questions arising in clinical laboratories community on quality assessment and performance of In Vitro Diagnosis (IVDs) process in Iran, we are publishing a descriptive detailed process of Ministry of Health & Medical Education (MHME) role in achieving a permit for importing or local production of IVDs, supervi-sions on distribution, consumption, post market-ing monitoring, limitations, and future prospects of Reference Health Laboratory (RHL) and its role in improving each step.
The quality assessment & performance of IVDs program, is among other important quality assur-ance issues in medical laboratories of Iran started at RHL of MHME many years ago. At that time the results of a data set produced by RHL was the base for introducing and choosing of a product in the market. However, in recent years, issues such as introducing different technologies, competition of companies (local manufactures /importers), variety in clinical assessment analysis along with significant technical performance differences among IVDs in conducted analytical and clinical studies, and also different relevant certificates and approvals in a product technical file, have caused the clinical laboratories & technology manage-ment office to breakdown the evaluation process and consider other effective parameters to im- prove the investigation steps. These processes which at present are being proceeded in Medical Equipment office (MEO) with RHL cooperation for reviewing the technical file and performance evaluation are as follows (1-3):
1- A company Registration
All legal & real people according to law may act in manufacturing, and in IVDs importing. The necessary steps are:
* Introduce themselves to MEO and present a sample of the company's stamp with neces-sary documents indicating authorization of them.
* Fill out necessary application forms.
* Pass the training courses with at least mini-mum acceptable score.
* Receive an activity I.D from MEO after pre-senting all necessary documents and permits.
2- IVD Registration
The applicant at this step presents an appropriate request for reviewing the IVD/s technical file to MEO. The technical file should be in special for-mat and contain(2,3) the following items:
* Executive Summary
* Device Description
* Design Philosophy
* Marketing History
* Standards Lists
* Performance Evaluation Documents
* Common Technical Specifications (CTS)
* Risk Management
* Quality Management System (ISO 13485)
* International Certificates: FDA, CE or CE Declaration of Conformity (whether or not).
Each of the above sections reveals important information on a product quality and performance specifications. For example, marketing history has a valuable impact indicating the product has al-ready been distributed in regulated international markets. Furthermore, if validity of international certificates is suspected, it is clarified through communication with issuing agencies.
The responsibility of RHL, as mentioned earlier, is reviewing the technical file of products in details by its expert technologist, and performance evaluation in cases that is needed. If the gathered data are complete and adequate, they are pre-sented at "Registry Committee" and the final re-sult is then reported to MEO.
The members of IVDs Registry Committee, held 2-3x monthly at RHL, are RHL general director and representatives from two offices as fixed members. In addition, experts from other related organs may be invited to attend the relevant ses-sions of the committee. The final decision of committee is categorized in four different groups:
* To evaluate a product technically at RHL or other collaborating laboratories based on RHL protocol.
* To receive an import permit for a limited number of products after necessary quality and IVDs performance evaluation in collaborating laboratories at specific time period determined by RHL. …