AEMPS – Agencia Española de Medicamentos y Productos Sanitarios
AEFI – Asociación Española de Farmaceuticos de la Industria
AFSSAPS – Agence Française de Sécurité Sanitaire des Produits de Santé (France) – Agencia Francesa para la Seguridad de los Productos Sanitarios (Francia)
ANSI – American National Standards Institute – Instituto Nacional Estadounidense de Normativa (analogo a ISO, IEC para USA)
ANVISA – Agencia Nacional de Vigilancia Sanitaria (en portugués, Agência Nacional de Vigilância Sanitária, ANVISA) es la agencia que regula los productos sanitarios en Brasil.
ASQC – American Society for Quality Control – Sociedad Estadounidense para el Control de Calidad
Australian Sponsor – An Australian Sponsor is a representative appointed by a non-Australian medical device and IVD manufacturer to act as a contact liaison with the Therapeutic Goods Administration (TGA). An Australian Sponsor must be a resident of Australia or maintain a place of business in Australia. – Un Sponsor australiano es un representante designado por un fabricante de productos sanitarios no australiano para actuar como enlace con la Administración de Productos Terapéuticos (TGA). El patrocinador australiano debe residir en Australia o tener un lugar de negocios en Australia.
BOM – Bill of Materials – Lista de materiales (para software SBOM)
BSI – British Standards Institute. Organización responsable normativa en UK y Organismo Notificado para MD UK y su homonimo en Paises Bajos para MDR/IVDR
CA – Competent Authority – Autoridad Competente (para productos sanitarios AEMPS en España)
CAPA -Corrective and Preventive Action – Acciones correctivas y preventivas
CAR – Corrective Action Request or Corrective Action Record – Solicitud de acción correctiva o registro de acción correctiva
CCC Mark – The China Compulsory Certificate mark, commonly known as CCC Mark, is a safety mark for many products sold on the Chinese market. As of 2013, medical devices do not require this certification. La marca de Certificación Obligatoria de China, comúnmente conocida como Marca CCC, es un sello de seguridad para muchos productos vendidos en el mercado chino. Desde 2013, los dispositivos médicos no requieren esta certificación.
CCPS – Comunicaciones de Comercialización y/o puesta en servicio de Productos Sanitarios – base de datos de la AEMPS para el registro de productos de la clase IIa, IIb y III y agrupaciones, sustituida por el Registro de Comercialización RECO PS
CDRH – Center for Devices and Radiological Health (USA) , departamento que se ocupa de los medical devices de FDA
CE Marking – The CE Marking is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements. By affixing the CE marking to a product, the manufacturer declares that it meets EU safety, health and environmental requirements. El marcado CE es una marca de conformidad obligatoria para muchos productos comercializados en el mercado único del Espacio Económico Europeo (EEE). El marcado CE certifica que un producto cumple con los requisitos de seguridad, salud y medio ambiente de la UE. Al colocar el marcado CE en un producto, el fabricante declara que cumple con dichos requisitos.
CEN – Communité Européenne des Normes (European Committee for Standardization) – Comité Europeo de Normalización
CFR – Code of Federal Regulations (USA)
CFU – Colony Forming Unit – Unidad Formadora de Colonias (UFC)
CINA PS – Centro de Información Nacional de Productos Sanitarios , base de datos pública con el contenido de RECO PS
Clinical Trial – Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place. Ensayo clínico: Los ensayos clínicos se realizan para recopilar datos sobre la seguridad y la eficacia de las intervenciones sanitarias (por ejemplo, medicamentos, pruebas diagnósticas, dispositivos, protocolos terapéuticos). Estos ensayos solo pueden llevarse a cabo una vez que se haya obtenido información satisfactoria sobre la seguridad no clínica y se haya concedido la aprobación de la autoridad sanitaria o del comité de ética del país donde se realiza el ensayo.
Clinical Trial Sponsor – The Clinical Trial Sponsor is responsible for the safety of subjects in a clinical trial and informs local site investigators of the true historical safety record of the drug, device or other medical treatment to be tested, and of any potential interactions of the study treatment(s) with already approved medical treatments.
Patrocinador del ensayo clínico: El patrocinador del ensayo clínico es responsable de la seguridad de los sujetos que participan en un ensayo clínico e informa a los investigadores locales del historial real de seguridad del fármaco, dispositivo u otro tratamiento médico que se va a probar, así como de cualquier posible interacción del tratamiento o tratamientos del estudio con tratamientos médicos ya aprobados
CMDCAS – Canadian Medical Devices Conformity Assessment System – Sistema Canadiense de Evaluación de la Conformidad de Productos Sanitarios
CMDR – Canadian Medical Device Regulation – Reglamento Canadiense de Productos Sanitarios
CNCps – Centro Nacional de Certificación de Productos Sanitarios ON 0318
CR – Change Request – Solicitud de cambio
CRF – Change Request Form – Formulario de solicitud de cambio
CRO – A Contract Research Organization, also called a Clinical Research Organization, is a service organization that provides support to the healthcare industries. CROs offer clients a wide range of «outsourced» research services to aid in the drug and medical device research and development process.
CRO (Organización de Investigación por Contrato), también conocida como Organización de Investigación Clínica, es una organización de servicios que brinda apoyo a las industrias sanitarias. Las CRO ofrecen a sus clientes una amplia gama de servicios de investigación externalizados para facilitar el proceso de investigación y desarrollo de fármacos y dispositivos médicos.
cGLP – Current Good Laboratory Practice (USA)
CSR – Customer Service Representative – Representante de Servicio al Cliente
DCMS – Design Change Master Sheet
Design Dossier – See Technical Documentation
DHF – Device History File
DHR – Device History Record
DIMDI – Deutsches Institut für Medizinische Dokumentation und Information (German Institute of Medical Documentation and Information)
DMR – Device Master Record
DTC – Design Transfer Checklist
EC REP o EU-REP – A European Authorized Representative (EC REP) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives an Regulations. Un Representante Autorizado Europeo (EC REP o EU REP) es una entidad jurídica designada por fabricantes no pertenecientes a la Unión Europea (UE) para representarlos en la UE y garantizar su cumplimiento con las Directivas y Reglamentos europeos.
EDMA – European Diagnostic Manufacturer’s Association
EEA – The European Economic Area includes the 27 European Member States plus Iceland, Liechtenstein and Norway.
EEC – European Economic Community, also referred to as the European Community, which has now become part of the European Union.
EFTA – The European Free Trade Association is a free trade organization between four European Countries (Iceland, Liechtenstein, Norway and Switzerland) that operates parallel to, and is linked to, the European Union.
EMC – Electro-Magnetic Compatibility
EN – European Standards (EN) for various sectors that were created by the European Committee for Standardization (CEN). Some standards are voluntary, whereas other standards are mandatory under EU law.
EU – The European Union is an economic and political union of 27 Member States.
EUDAMED – European Database on Medical Devices
FDA – The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
FENIN – Federación Española de Empresas de Tecnología Sanitaria agrupa a fabricantes y distribuidores establecidos en España
FMEA – Failure Mode and Effects Analysis
FOIA – Freedom of Information Act (USA)
FTA – Fault Tree Analysis
Gap Analysis – Gap analysis is a tool that helps a company to compare its actual performance with its potential performance.
GCP – Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial, assurance of the safety and efficacy of the newly developed compounds, and standards on how clinical trials should be conducted.
GHTF – Global Harmonization Task Force
GMP – Good Manufacturing Practice refers to the quality system requirements for medical device (and other) companies outlined by the US FDA in 21 CFR Part 820. Also referred to as the Quality System Regulation (QSR).
Green Dot – The Green Dot (German: Der Grüne Punkt) is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods as per the European «Packing and Packaging Waste Directive -94/62/EC.» This applies to medical devices as well.
Health Canada – Health Canada is the official regulatory agency that reviews medical devices to assess their safety, effectiveness and quality before they are authorized for sale in Canada.
IDE – An Investigational Device Exemption allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration (FDA).
IFU – Instructions for Use – Instruciones de uso
ISO 13485 – ISO 13485 is an ISO standard, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. Norma ISO, que establece los requisitos para un sistema de gestión integral para el diseño y la fabricación de productos sanitarios.
ISO 14971 – ISO 14971 is an ISO standard that represents the requirements for a risk management system for medical devices. This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle.
ISO 9001 – ISO 9001 is an ISO standard that represents the requirements for quality management systems. It is used across industries and is not specific to medical devices like ISO 13485.
IVD – In Vitro Diagnostic tests are medical devices intended to perform diagnoses from assays in a test tube, or more generally in a controlled environment outside a living organism.
IVDD – In Vitro Diagnostic Device Directive – Directiva 98/79 de productos sanitarios para diagnóstico in vitro – Sustituida por la IVDR – reglamento 2017/746
IVDR – Reglamento 2017/746 de productos sanitarios para diagnóstico in vitro
MDD – Medical Device Directive – Directiva 93/42 de productos sanitarios – Sustituida por la MDR – reglamento 2017/745
MDEL – A Medical Device Establishment License is a certification issued by Health Canada. Class I medical device manufacturers must secure a MDEL if selling directly to Canadian consumers and not through a distributor.
MDR – Medical Device Report (USA)
MDR – Reglamento 2017/745 de productos sanitarios (EU)
MDUFMA – Medical Device User Fee and Modernization Act of 2002 (USA)
MDV – Medical Device Vigilance (EU)
Medical Device – A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery.
MHRA – The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
Ministry of Health – The health department (or Ministry of Health ) is a part of the government which focuses on issues related to the general health of the citizenry.
MPR – Medical Problem Report (Canada)
MR – Management Representative
MSDS – Material Safety Data Sheet
NCR – Non-Conformance Report
NIH – National Institutes of Health (U.S.)
Notified Body – A Notified Body, in the European Union, is an organization that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture.
OTC – Over the Counter
PMA – Premarket approval by FDA is the required process of scientific review to guarantee safety and effectiveness for Class III devices.
PMDA – The Pharmaceutical and Medical Devices Agency in Japan reviews applications for marketing approval of pharmaceuticals and medical devices. It also monitors their post-marketing safety and provides relief compensation for people who have suffered from adverse drug reactions from pharmaceuticals or infections from biological products.
PMS – Post Marketing Surveillance is the practice of monitoring a device after it has been released on the market.
PNT – Procedimiento Normalizado de Trabajo, SOP en inglés
PRRC – PRCN Persona Responsable del Cumplimiento de la Normativa. Cargo según MDR / IVDR del responsable según requisitos de articulo 15
QA – Quality Assurance refers to a program for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.
QMS – Quality Management System can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.
QP – Quality Policy
QSP – Quality System Procedure
QMSR – Quality Management System Regulations. Requisitos de calidad para productos sanitarios en USA – FDA. Incluye por referencia la ISO 13485 y la 21CFR820 establece el GAP con la norma internacional.
RA – Return Authorization. Can also refer to «Regulatory Affairs.»
RA – Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides,agrochemicals, cosmetics and complementary medicines.
RECO PS – Registro de Comercialización base de datos de la AEMPS para el registro de productos de la clases I, IIa, IIb y III y agrupaciones. Sustituye a la CCPS y RPS que queda solo para ps a medida
Registered Certification Body Japan – Independent companies authorized by the MHLW to certify Specified Controlled Medical Devices and issue Pre-Market Certifications.
RPS base de datos de la AEMPS para el registro de productos de la clase I que pasa a ser para los ps a medida al entrar en funcionamiento el RECO PS
SEEIC – Sociedad Española de Electromedicina en Ingenieria Clínica
SEIB – Sociedad Española de Ingenieria Biomédica
SEIS – Sociedad Española de Informatica de la Salud
SOP- Standard Operating Procedure, procedimiento normalizado de trabajo PNT
STED – A Summary TEchnical Document (STED) is a standardized format for submitting information for regulatory approval of new devices. The STED format was created by the Global Harmonization Task Force (GHTF). The long term goal of STED is to standardize regulatory submissions for many countries.
Technical Documentation – is a comprehensive collection of documents that demonstrates a product’s technical basis for conformity to the applicable directive(s). It is required by the CE Marking Regulations.
TGA – The Therapeutic Goods Administration is a unit of the Australian Government Department of Health and Ageing that regulates medical devices, IVDs and drugs in Australia.
TR – Técnico Responsable, cargo establecido en la legislación española de productos sanitarios para fabricantes, importadores, agrupadores y distribuidores que precisa titulación universitaria y cuya responsabilidad es la supervisión de las actividades de la instalación
US Agent – A US Agent is a representative is appointed by a non-US medical device of
IVD manufacturer to act as a contact liaison with the US FDA. A US Agent must be a resident of the United States or maintain a place of business in the US.
USP – United States Pharmacopoeia
Validation – Validation is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements.
Warning Letter – A warning letter is a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.
WHO – World Health Organization
WI – Work Instructions
WTO – World Trade Organization
