[2] 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 automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration.
Other specific differences include: Compliance with ISO 13485 is often viewed as the initial step in ensuring adherence to European regulatory requirements.
When a Notified Body conducts a thorough evaluation and issues a positive assessment, it results in the coveted certificate of conformity, granting the CE mark and the authorization to market the medical device within the European Union.
It's important to underline that the Notified Body's assessment scrutinizes the company's Quality Management System in great detail, along with a meticulous review of the requisite Technical Documentation.
[5] ISO 13485 is now considered to be inline standard and requirement for medical devices even with "Global Harmonization Task Force Guidelines" (GHTF).
[8] Mexico published on October 11, 2012, a national standard as a Norma Oficial Mexicana (NOM) to control manufacture of medical devices inside the country.
The Cofepris is the body assigned to its control, verification and to grant the records of compliance to the companies that implement this Standard of Good Manufacturing Practices.