The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > Other Medical Device Regulations World-Wide
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

INMETRO (Brazil) Certification for Syringes, Needles and Infusion Sets


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links



Courtesy Quick Links

Links that Cove visitors will find useful in your quest for knowledge:


ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Atul's
Quality Forum Online

Howard's
International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Related LinkedIn Groups

ISO 9001 for Small Businesses

ISO 9001:2015 Revision Discussions

Information Security Community

Medical Devices Group

Quality and Regulatory Network

FDA (Food and Drugs)

AS91XX Series - Tips and Advice


Related Topic Tags
brazil, cadastre process (simplified registration), infusion pumps and devices, inmetro certification process, inmetro mark (brazilian conformity mark), syringes
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 5th January 2012, 11:45 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,771
Look! INMETRO (Brazil) Certification for Syringes, Needles and Infusion Sets

Hello all

Continuing the trend of Anvisa using INmetro certification as a means to verify some claims of safety and efficacy of medical devices, Inmetro published last week 3 new regulations - certification for syringes, needles and infusion sets.

The certification process uses Type 5 (the same as medical equipment certification) or type 7 (batch) iso certifications ans will required prior to registrations/cadastre of these devices. They also uses ISO standards for type testing.

In portuguese, on the following links:

Portaria INMETRO / MDIC número 501 de 29/12/2011 - Requisitos de Avaliação da Conformidade para Agulhas Hipodérmicas Estéreis para Uso Único e Agulhas Gengivais Estéreis para Uso Único

Portaria INMETRO / MDIC número 502 de 29/12/2011 - Requisitos de Avaliação da Conformidade para Equipos de Uso Único de Transfusão, de Infusão Gravitacional e de Infusão para Uso com Bomba de Infusão

Portaria INMETRO / MDIC número 503 de 29/12/2011 - Requisitos de Avaliação da Conformidade para Seringas Hipodérmicas Estéreis de Uso Único

Sponsored Links
  Post Number #2  
Old 16th August 2012, 12:16 PM
maitre

 
 
Total Posts: 4
Re: INMETRO (Brazil) Certification for Syringes, Needles and Infusion Sets

Thanks Marcello for this information.
Looks like we have to expect a bunch of other products requiring the certification in the next future, isn't it?
How do I find the OCB that has the equipment performing the tests?
The scopes may just say "non-active products"...Can I find a comprehensive list of medical devices with mandatory INMETRO Certification?

I also found this N° 162 of 2012 (RTAC001804.pdf) on breast implants... Do the OCB provide tests on the breast implants?
Sponsored Links

Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > Other Medical Device Regulations World-Wide

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Medical Device Approval in Brazil - Understanding INMETRO and ANVISA Roland chung Other Medical Device Regulations World-Wide 92 8th June 2015 04:59 PM
Medical Equipment Inmetro Certification Process in Brazil - Part 2 Marc Other Medical Device Regulations World-Wide 3 17th January 2014 11:16 AM
Medical Equipment Inmetro Certification Process in Brazil - Part 1 Marcelo Antunes Other Medical Device Regulations World-Wide 45 6th November 2013 04:14 PM
Is INMETRO certification suitable for medical device components? Roland chung IEC 60601 - Medical Electrical Equipment Safety Standards Series 5 21st November 2012 02:57 PM
Anvisa & INMETRO - Registering Non-Electrical Medical Devices in Brazil sandieash Other Medical Device Regulations World-Wide 2 29th May 2012 01:15 AM



The time now is 06:18 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 


NOTE: This forum uses "Cookies" -- The Elsmar Cove is *Copyright Free*.
A Peachfarm LLC Internet Property