SBS - The Best Value in QMS software

Medical Device Regulation Cameroon

3

3l5m4r

#1
Hey there-

Does anyone have any information on medical device regulations in Cameroon?

The only info I have so far is what is contained in the attached file, but according to the person from whom I've received this, it pertains disposables only and (also according to that person) there are no further medical device regulations for non-disposables (which is somehow hard to believe).
I'd be glad if someone could help me out with this...
 
Elsmar Forum Sponsor
L

LFZR88

#3
Hi,
I can't see the file so I don't know what it contains.
I'm afraid I don't have much information for you apart from I believe you need to have an authorised representative in country, Cameroon does not yet have a formal classification system and registration is based upon the acceptability of the device in its country of origin.
the website for the ministry of public health in Cameroon is http://www.minsante.cm/ you may find some better help there, good luck.
 
M

MMBer

#5
Does anyone know how difficult it is to change the Cameroon in country authorized representative. Does the authorized representative have to be the distributor?
 
Thread starter Similar threads Forum Replies Date
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 6
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 13
H Online courses/program for medical device regulation EU Medical Device Regulations 4
M Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 1
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems US Food and Drug Administration (FDA) 18
M Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re Medical Device and FDA Regulations and Standards News 7
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
M Informational Medtech Europe – Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR) Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
J Control of Medical Device Marketing and Promotional Materials - EU regulation EU Medical Device Regulations 20
M Medical Device News TGA – Regulation of Software as a Medical Device Medical Device and FDA Regulations and Standards News 0
K Russia - Medical Device Regulation Including Definitions Needed Other Medical Device Regulations World-Wide 3
B New EU Medical Device Regulation & Reconciling with EN ISO 14971 EU Medical Device Regulations 41
G How do Medical Device Standards vs Directive vs Regulation technically vary? Other Medical Device and Orthopedic Related Topics 7
X Where to find UAE medical device registration regulation and guidelines Other Medical Device Regulations World-Wide 3
A Regulation / Requirements about dump/crash files for medical device software Other Medical Device Related Standards 1
K Medical Device Software Version Upgrade Regulation Impact 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Regulation Approach on Mobile Application which is Medical Device Acccesory EU Medical Device Regulations 1
K Device regulation document for medical application Other US Medical Device Regulations 2
R Regulation Process for Add on Accessory to an Existing Medical Device Other US Medical Device Regulations 1
J Medical Device Regulation - Cambodia Other Medical Device Regulations World-Wide 6
T Myanmar Medical Device regulation Other Medical Device Regulations World-Wide 4
E Is our equipment a Medical Device under US regulation ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
M Medical Device Regulation in Cambodia Other Medical Device Regulations World-Wide 5
M Medical Device Regulation in Mongolia - Can someone help? Other Medical Device and Orthopedic Related Topics 3
R Regulation/Standard for Labelling in the UK - Medical Device Directions for Use ISO 13485:2016 - Medical Device Quality Management Systems 7
S SFDA Regulation of Medical Device Recall (Interim) - MOH decree No. 82 China Medical Device Regulations 1
Ajit Basrur Indian Medical Device Regulation may be passed by this Aug 2011 Other Medical Device Regulations World-Wide 11
somashekar Medical Device Regulation - Singapore - 1st May 2010 Other Medical Device Regulations World-Wide 4
C Teaching Medical Device Regulation and Validation - Course Content ISO 13485:2016 - Medical Device Quality Management Systems 11
D Regulation on Bioresorbable Oil Residue Level on Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Italian Ministry of Health Medical Device Databank regulation Other Medical Device Regulations World-Wide 61
Ajit Basrur APEC Seminar on Harmonization of Medical Device Regulation (4-7, March) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
H Regulation in Australia - Importing medical device (class IIa as per MDD 93/42/EEC) ISO 13485:2016 - Medical Device Quality Management Systems 3
J Shoe Covers - medical device class I EU Medical Device Regulations 3
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4
Ed Panek Apple Provides New Medical Device Cautions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 1
DanBOS Cloud Connected Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1
S Obsolescence of the Medical Device in Various Countries Other Medical Device Related Standards 1
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 3

Similar threads

Top Bottom