Radio modular approval in Brazil

O

occounty

Involved In Discussions
#1
#1
Hi,

Our medical device has an radio module that needs to be certified at the modular level. We have finished the Single Modular Approval [SMA] with FCC.
FCC KDB document 996369 D01 can be referred for different types of radio modular approval and also covers the list of requirements for qualifying radio for SMA. So in nutshell, these modular approval are beneficial so that majority of the testing can be performed can be performed in a standalone configuration so that when it is integrated in any other host - only gap testing is required and hence results in reduced amount of testing at host level integration. So I was wondering if there is any document that covers the Single Modular Approval qualifications for Brazil market for ANATEL certification.

Your help will be greatly appreciated.
Thanks!
 
Paper to QMS ad
Elsmar Forum Sponsor
O

occounty

Involved In Discussions
#2
#2
Hi all,

Our radio module that we got modular FCC approval also qualified for modular approval for Brazil Anatel mark. UL confirmed that Brazil supports radio modular approval. They also confirmed that host using this approved radio module will not require any additional radio or EMC testing. Only host need to be labelled for "Contains..." stating the modular approval details.
 
Marc

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
#3
Thank you for following up with us. It is much appreciated!

I apologize that no one here could help.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
O Radio Modular approval in China China Medical Device Regulations 0
M RFID (Radio Frequency Identification) Registration in Europe and in MENA countries EU Medical Device Regulations 1
F Is EMC + Radio Re-Test Required? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Q RFID (radio frequency identification) registration for Medical Device Other Medical Device Regulations World-Wide 6
Marc Definition RED = Radio Equipment Directive Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
T Testing bluetooth medical devices against Japan Radio Law requirements Japan Medical Device Regulations 2
R IEC 62304 - Medical Device Wi-Fi Radio Requirements IEC 62304 - Medical Device Software Life Cycle Processes 5
M Global Radio Frequency Regulations for Medical Devices Medical Information Technology, Medical Software and Health Informatics 3
M Radio Directive question about Wireless Device to Device Communication CE Marking (Conformité Européene) / CB Scheme 5
T GPRS (General Packet Radio Service) and EMC IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Is FCC required for Medical Equipment without Radio Frequency Energy? Other US Medical Device Regulations 5
Marc Tour of Manhattan from a Radio Controlled (RC) Plane Coffee Break and Water Cooler Discussions 4
Jim Wynne Tech Guy Radio: Woman Wants Help in Getting Her Stolen Internet Connection Back After Work and Weekend Discussion Topics 2
Tim Folkerts Pandora Radio - streaming *your* music Coffee Break and Water Cooler Discussions 24
J Re: Review my ISO 9001:2000 Quality Manual - Radio Broadcaster (Latvia) Quality Management System (QMS) Manuals 15
Marc Radio Controlled Airplanes Funny Stuff - Jokes and Humour 0
ScottK Save Internet Radio After Work and Weekend Discussion Topics 25
A Radio & Telecommunications Terminal Equipment Directive 1999/5/EC CE Marking (Conformité Européene) / CB Scheme 5
Marc Broadcast Radio Turns 100 World News 0
Wes Bucey RFID (radio frequency identification) Tags - Inventory and WIP Tracking Misc. Quality Assurance and Business Systems Related Topics 19
M Druck DPI 620 Advanced Modular Calibration System General Measurement Device and Calibration Topics 1
B Document Approval Matrix Benchmarking Document Control Systems, Procedures, Forms and Templates 3
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
B SN95 Respirator Approval Information Other Medical Device Related Standards 0
P Notified Body Approval of Change EU Medical Device Regulations 2
Marcel DS GOST-R (Type approval for Vehicles in Russia) Other ISO and International Standards and European Regulations 0
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
F How to fill out an Appearance Approval Report (AAR) APQP and PPAP 0
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
I Can a document (form) approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Medical Devices - Hong Kong - Post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
C AS9145 Appendix D PPAP Approval Form APQP and PPAP 2
N China - Start manufacturing before change approval? China Medical Device Regulations 1
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
D ROW Approval Matrix Other Medical Device Regulations World-Wide 2
T Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial Other US Medical Device Regulations 9
S Education authority requires approval of all courses - Training services provider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Can Brazil approval be used for other countries in Latin America? Other Medical Device Regulations World-Wide 2
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
S NADCAP approval for Conventional Machining and Chemical processes - need assistance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
DuncanGibbons FAA approval of articles (PMA, TSO) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Criteria and when to carry out Setup Approval Manufacturing and Related Processes 5

Similar threads

Top Bottom