ISO 13485:2016 standard
According to the decision of the General Department of Medical Equipment of the Ministry of Health, IMED, all manufacturers of medical equipment in all risk classes are required to obtain the ISO 13485:2016 standard certificate and obtain the CE certificate in order to obtain or renew their manufacturing license.
The requirements for registration of medical equipment and the process of obtaining a manufacturing license
From 02/10/1997, medical equipment manufacturers are required to comply with the following:
1-2: Establishing a quality management system and providing a valid ISO 13485:2016 standard certificate from authorized CBs approved by the General Administration
note 1 : Providing ISO13485 certificate is mandatory for manufacturers of medical equipment with risk class A and B from 01/10/97.
Note 2: Manufacturers of medical equipment with risk class A and B, who succeeded in obtaining a manufacturing license before 01/10/97, have the opportunity to submit the ISO13485 certificate until 01/10/97, and if they do not provide the said certificate, their manufacturing license will be withdrawn from 02/10/97 will be canceled.
Note 3: The ISO13485:2003 and EN ISO13485:2012 certificates issued are only valid until February 28, 2019, and after that date, only the ISO13485:2016 certificate is approved for establishing the quality management system.
Note 4: The address mentioned in the ISO13485 certificates must be related to the active production line of the company and for the desired product.
2-2: Complying with international standards and providing CE and a certificate of compliance with the legal requirements of the General Administration from an authorized NB approved by the General Administration
Note: The address mentioned in the CE certificate must be related to the active production line of the company and for the desired product.
2-2-1- Medical equipment with risk class A
Complying with international standards and legal requirements of the labor department and providing a certificate of compliance by the technical officer of the company and the CEO and other relevant managers whose powers are determined within the framework of the law.
2-2-2- Medical equipment with risk class B
Providing CE and a certificate of compliance with the legal requirements of the General Administration from an authorized NB approved by the General Administration is mandatory for this group from 01/01/98.
2-2-2-1- Manufacturers who have successfully obtained a manufacturing license before 1998 according to the registration instructions, have the opportunity to present CE until 06/31/1998. And if CE is not provided, their manufacturing license will be canceled from 07/01/98.
2-2-2-2- The process of reviewing the medical equipment registration file for the purpose of issuing a manufacturing license, which was previously sent to the General Administration and is under review, will continue. This is while the mentioned producers will only have the opportunity until 07/01/1998 to submit the CE certificate of compliance with the legal requirements of the General Administration from the authorized NB.
Note: At this stage, this group of applicants can apply for CE and certificate of compliance with the legal requirements of the General Administration from an authorized NB.
2-2-3- Medical equipment with risk class C and D
Providing CE and a certificate of compliance with the legal requirements of the General Administration from an authorized NB is mandatory for this group from 10/02/97.
2-2-3-1- The manufacturers who succeeded in obtaining a manufacturing license before 02/10/1997 have the opportunity to obtain CE until 10/01/1997. And if CE is not obtained, their manufacturing license will be canceled from 02/10/97.
2-2-3-2- The process of reviewing the registration of medical equipment with risk class C and D for the purpose of issuing a manufacturing license, whose technical documentation has already been sent to the General Directorate and is being reviewed in the General Directorate, will continue. . But these producers will also have time until 01/10/97 to obtain CE.
2-2-3-3- At this stage, this group of applicants can obtain and submit CE and a certificate of compliance with the legal requirements of the General Administration from an approved authorized NB.
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