Home / Knowledge : Administration & Management

Good Distribution Practice (for Medical Devices)

Good Distribution Practice (For Medical Devices)

First revision: Apr.17, 2018
Last revision: Apr.17, 2018
written and gathered by: Apirak Kanchanakongkha

First of all, we sholud understanding the Good Manufacturing Practice - GDP first.

GDPMD is related to ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN-46001 and En 46002 (both 1997), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996)
The current ISO 13485 effective edition was published on 1 March 2016.

Background:
Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automative sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automative task Forces supply chain manufacturer can seek registration.

Reason for use:
While it remains a stand-alone document, ISO 13485 is generally harmonied with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, wherease ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.

Other specific differences include:

the promotion and awareness of regulatory requirements as a management responsibility. Examples of market-specific regulatory requirements include 21 CFR 820, the Quality System Regualtion for medical devices sold in the United States, enforces by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union.
controls in the work environment to ensure product safety.
focus on risk management activities and design control activities during product development.
specific requirements for inspection and traceability for implantable devices
specific requirements for documentation and validation of processes for sterlie medical devices
specific requirments for verification of the effectiveness of corrective and preventive actions.

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. One of the major requirements to prove conformity is the implementation of the Quality Management System according ISO 9001 and/or ISO 13485 and ISO 14971. Although the European Union Directives do not mandate certification to ISO 9001 and/or ISO 13485 the preferred method to prove compliance to such standards is to seek its official certification which is issued by certify organizations known as "Registrars". Several registrars also act as Notified Body. For those medical devices requiring the pre-market involvement of a Notified Body. the result of a positive assessment from the Notified Body is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union. A very careful assessment of the company Quality Management System by the Notified Body, together with the review of the required Technical Documentation, is a major element which the Notified Body takes into account to issue the certificate of conformity to the company product(s).

back

info@huexonline.com

Visit : 4740800