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Dec 18, 2015 06:17
9 yrs ago
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Spanish term

REGISTROS SANITARIOS

Spanish to English Law/Patents Law (general) AREA OF EXPERTISE IN A FIRM
It's an area of expertise in a law firm. The attorney is in charge of REGISTROS SANITARIOS. Someone who lives in the US told my client that REGISTROS SANITARIOS should be translated not as HEALTH REGISTRY but just as REGULATORY, all by itself.

In other words, in the US, according to the US resident, it's normal to see REGULATORY by itself meaning REGISTROS SANITARIOS.

But the way I understood it, it's that instead of HEALTH REGISTRATION or HEALTH RECORDS, or HEALTH REGISTERS, it should be called HEALTH REGULATORY.

Is any of this correct? What is the right way to use it IN THE US?

Thanks guys!
Proposed translations (English)
4 +1 HEALTH RECORDS
4 Sanitary Registrations

Discussion

Charles Davis Dec 20, 2015:
Well, there is certainly a big overlap between "sanitary" and "health", but to my mind, sanitary regulation is specifically to do with protecting public health by preventing the circulation of harmful food, animals and plants, that are contaminated or contain pathogens, for example. I think the European Sanitary Regulations are about that, not about licensing medicines or medical devices. And I think the Registro sanitario is largely about the latter.

To me, "health registration" covers both: sanitary registration is a form of health registration. "Health" here simply means health-related. It doesn't exactly mean that what is registered is "healthy"; I suppose it really means it's not harmful to health.

Can a chemotherapy medication be "healthy" or "healthful"? I would have thought so, since in current medical practice it is a means by which a cancer patient's health can be restored. It commonly makes you feel extremely unhealthy, but it offers some chance of delaying death or making it less likely. I really don't think the word "sanitary" applies here. But that's just me!
Robert Carter Dec 20, 2015:
...continued Although, as the above (below?) example shows, the EU appears to use sanitary and health interchangeably, i.e. "phytosanitary requirements", "plant-health requirements" even on the same page.
http://www.ams.usda.gov/services/imports-exports/dairy-sanit...
http://academy.iglobalstores.com/2011/11/02/international-ex...
http://www.foodsafety.govt.nz/industry/exporting/certificati...
Robert Carter Dec 20, 2015:
@Charles Thanks for getting back on this with insightful commentary. While I appreciate your reservations on this word, I still find health to be a rather inadequate equivalence, as it conveys at least to me, something beyond the realm of hygiene and safety, namely a qualification of the product as "healthful". Perhaps I'm being a bit picky, but I don't see how, for example, a chemotherapy medication, or even a processed beef product (as the term relates to food preparation also), can be described as "healthy" or "healthful", whereas I would see "sanitary" as a perfectly reasonable qualifier.
I will grant you that "health" is used in this way in many government departments around the world, but this doesn't really undermine my argument for the use of "sanitary" where it is in fact applicable.
In addition, it is also a term with fairly consistent usage in English speaking countries in relation to this area of regulation:
http://www.exporthelp.europa.eu/thdapp/display.htm?page=rt/r...
(continued in next entry...)
Charles Davis Dec 20, 2015:
@Robert Sorry to have taken so long to answer your very reasonable request for clarification. My problem with "sanitary" is that I think it basically refers to hygiene, freedom from dirt, provision of clean water and disposal of human waste, that sort of thing — a more restricted range of meanings than "sanitario" in Spanish. I don't think this is really what "registros sanitarios" are about. It seems to me that in relation to health products (medicines, devices, etc.) it would really apply to hygienic conditions of production, freedom from contamination, and so on, which would be covered by inspection of production facilities, whereas the registro sanitario is about the inherent qualities of the products themselves, since it is the products that are registered. I find "registro sanitario" described (in relation to medicines) as "un certificado del gobierno mexicano de eficacia y seguridad". I think "health registration", which is a very broad term, after all, would be OK.
Robert Carter Dec 18, 2015:
Regulatory Just to add to my point below about the term "regulatory", as used by your client, they are referring to the area within the firm that deals with regulatory law, which presumably includes them dealing with applications for these sanitary registrations and authorizations. As we've seen on here, the term "sanitary registration" doesn't really mean a lot to English speakers (not our fault, we don't have the same system), so your client would prefer a term they are more likely to understand, i.e. "regulatory" (law), in order to offer their services.
Robert Carter Dec 18, 2015:
@Neil I've just posted a few other references below to explain my opinion. Regards.
Justin Mattos Dec 18, 2015:
No, in American English, that doesn't mean anything. It sounds fairly off. It would have to be the shortened and understood version of something else, which would mean he was in charge of health regulatory law? Or health regulations? Which wouldn't be a good translation of registros.
Ivannia Garcia (asker) Dec 18, 2015:
So neither is REGULATORY used all by itself?
Justin Mattos Dec 18, 2015:
or medical records.
Justin Mattos Dec 18, 2015:
In the US, Regulatory is either an adverb or an adjective. Health Regulatory doesn't make sense. It's either health registrations or health records depending on what you are talking about. If you are talking about files kept describing a patient's health history, it is health records.
Ivannia Garcia (asker) Dec 18, 2015:
Pero, la cliente insiste en usar REGULATORY... se usa? Es lo preferido en USA?
Taña Dalglish Dec 18, 2015:
@ Ivannia http://www.proz.com/kudoz/english_to_spanish/law_contracts/4... (see previous glossary entry)
health registrations

Proposed translations

+1
2 hrs

HEALTH RECORDS

Unless someone is prepared to explain to me exactly why this is somehow considered unfit for purpose, this is the first thing that springs to mind.

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Note added at 8 hrs (2015-12-18 15:15:47 GMT)
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https://en.wikipedia.org/wiki/Medical_record

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Note added at 8 hrs (2015-12-18 15:16:40 GMT)
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Another option could be "medical record/s".
"The terms medical record, health record, and medical chart are used somewhat interchangeably to describe the systematic documentation of a single patient's medical history and care across time within one particular health care provider's jurisdiction."

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Note added at 8 hrs (2015-12-18 15:17:30 GMT)
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"Expert in medical records" gets over 52K hits on Google... (FWIW)
Peer comment(s):
agree Justin Mattos : Discussing that in the discussion section below
42 mins
"Medical records" is another possible option IMHO...
neutral Robert Carter : They're not medical records, Neil: http://www.cofepris.gob.mx/AS/Paginas/Registros Sanitarios/R...
7 hrs
Something went wrong...
1 hr

Sanitary Registrations

Having translated dozens of these over the year, and after looking at the various answers given by my learned colleagues, I can safely say that this is about as good an approximation as any, at least for the document that bears this name in Mexico. The registro sanitario is a document issued by the COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) stating that the product it covers has been manufactured in accordance with the World Health Organization's good manufacturing practices and that the facilities where it is made have been inspected by COFEPRIS to ensure they are compliant with those standards. It also contains a description of the product formula with quantities of ingredients and packaging specifications as a means of identifying the signature of the product (in the case of drugs). Now, this might be akin to other countries' drug or medical device registration processes, however it might also be a false equivalent to use terms such as formulary or the like, since this registro is specific to Mexico, and is a requirement for any "allopathic" (horrible term), as they call it, medical product sold legally here (obviously homeopathic remedies don't count as they don't contain any real medicinal ingredients).
I also prefer the term "sanitary" over "health" in this case as I think the registro does refer to matters of both hygiene and fitness for use, as well as contamination, but not specifically healthfulness.
As to your question regarding "regulatory", well no, that is not an effective translation for this term, however you could use it to describe an area of law that the law firm specializes in, and which covers this field (registration of products with sanitary authorities), particularly if your client prefers it. It is likely to be more understandable from their clients' point of view as well.

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Note added at 10 hrs (2015-12-18 16:33:08 GMT)
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Here's the COFEPRIS definition of the term from Mexico:
El registro sanitario, en los términos de la Ley General de Salud (Artículo 376), es una Autorización Sanitaria, con la cuál deberán contar los medicamentos, estupefacientes, substancias psicotrópicas y productos que los contengan; equipos médicos, prótesis, órtesis, ayudas funcionales, agentes de diagnóstico, insumos de uso odontológico, materiales quirúrgicos, de curación y productos higiénicos, estos últimos en los términos de la fracción VI del artículo 262 de la Ley General de Salud, así como los plaguicidas, nutrientes vegetales.
http://www.cofepris.gob.mx/AS/Paginas/Registros Sanitarios/R...

This is from the Costa Rican Health Ministry:
El registro sanitario es la autorización y el control que ejerce el Ministerio de Salud sobre los productos que son fabricados, importados, envasados o comercializados en el país, que sean de interés sanitario, previa verificación del cumplimiento de los requisitos establecidos en el marco legal correspondiente.
https://registrelo.go.cr/cfmx/plantillas/ms/ABC_Registrelo.p...

From Peru
http://www.digemid.minsa.gob.pe/conpro.asp

In Ecuador, the term extends to several product areas:
Retomando la sección de trámites en Ecuador, esta vez especificamos cómo obtener el Registro Sanitario. ¿Qué es? Según el Instituto Nacional de Higiene, entidad que otorgaba el documento, es un control que garantiza que un producto está aprobado para su consumo público, a fin de evitar “fallas terapéuticas relacionadas con calidad, falsificaciones y comercialización no autorizada” de fármacos, por ejemplo.
¿Quiénes deben obtener el Registro Sanitario? Según explica la Cámara de Industrias en su portal informativo, están obligadas a tramitarlo todas las personas naturales y jurídicas que lo requieran de los siguientes productos:
Medicamentos
Cosméticos
Productos higiénicos
Alimentos (productos nacionales y extranjeros)
Plaguicidas
Productos naturales (uso medicinal)
Dispositivos médicos
Reactivos bioquímicos
Toxicología
http://www.elemprendedor.ec/obtener-registro-sanitario-ecuad...

In Spain and various other countries, the registro sanitario applies to foodstuffs and fitness for human consumption:
¿Qué empresas están obligadas a solicitar el Registro Sanitario de Alimentos?
Las que elaboren alimentos.
Almacenistas.
Empresas de Distribución de alimentos.
Empresas de importación / exportación.
http://www.registro-sanitario.com

Se entiende por registro sanitario al aval emitido por el SENASAG a las empresas del rubro alimenticio que cumplen con el reglamento: “Requisitos sanitarios para fabricación, almacenamiento, fraccionamiento y transporte de alimentos y bebidas de consumo humano”, la “Norma de requisitos sanitarios para transporte de animales, infraestructura, clasificación de mataderos, proceso, almacenamiento y transporte de la carne” y los “Requisitos sanitarios para el transporte de aves, infraestructura y categorización de mataderos avícolas, proceso, almacenamiento y transporte de carne de ave”.
http://www.senasag.gob.bo/registros-unia/registro-sanitario....
http://www.panamatramita.gob.pa/tramite/registro-sanitario-d...
http://inan.gov.py/newweb/?page_id=519

Bolivia also has a category for medicines:
http://unimed.minsalud.gob.bo/unimed/consultas-reg-san.htm

In some cases it would need to be translated as "registry" instead of "registration" obviously, when referring to the administrative body that does the registering:
https://es.wikipedia.org/wiki/Registro_Sanitario_Industrial



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Note added at 12 hrs (2015-12-18 19:05:09 GMT)
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FDA Certification

FDA Registration or FDA registration number does not denote FDA certification of your facility or products. Any representation of registration number on product label or labeling which implies FDA certification or FDA approval of a facility or product is misleading and may cause misbranding of the product.
http://www.fdahelp.us/index.html?gclid=CNa-zpaL5skCFQMMaQodB...

Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
http://www.fdahelp.us/fda_registration/fda-registration-numb...
Peer comment(s):
neutral Charles Davis : Registration, certainly, but I'm not at all happy with sanitary.
8 hrs
What is your objection, Charles? (he says, absolutely certain that Charles is about to come up with something far better even as he writes this question :-)
neutral Justin Mattos : maybe a term that more clearly explains the concept would be a better fit? a registration is form of registration not approval of something. Just because something has been registered, doesn't mean anyone approves of it (at least in American English)
10 hrs
The thing is, there are nuances between registration and approval or authorization that I'm inclined not to mess with. I'll post a note to show you what I mean.
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