SBS - The Best Value in QMS software

Medical Devices-South Africa _Post approval changes and Software

#1
Hello,
Can somebody help me to know if the software are regulated in South Africa? and if changes need in the product (medical device) are reported and need to be approved by SAHPRA?

thanks
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
F Registration Process Guidance for Custom-Made Medical Devices in South/Latin America Other Medical Device Regulations World-Wide 11
M South Korea Importing Rules for Privately Labeled Medical Devices Advice wanted Other Medical Device Regulations World-Wide 5
A Importing Sample Medical Devices into South Korea ISO 13485:2016 - Medical Device Quality Management Systems 2
B Regulatory Requirements for for Class IIa Electro Medical Devices for South America Other Medical Device Regulations World-Wide 4
N Regulations for Registering Medical Devices in South Korea Other Medical Device Regulations World-Wide 6
M Medical Devices Registering (Registration) Procedure in South Africa Other Medical Device Regulations World-Wide 4
P Retention Samples for medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
dgrainger Informational EC - Medical devices – online manuals replacing paper instructions - Feedback period: 27 April 2021 - 25 May 2021 EU Medical Device Regulations 0
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R X-RAY Based Diagnostic Veterinary medical Devices Medical Device and FDA Regulations and Standards News 2
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 7
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 2
B Procedure packs with non-medical devices EU Medical Device Regulations 1
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
D Electrical Medical Devices class I EU Medical Device Regulations 0
J Are complaints applicable to development of medical devices? Customer Complaints 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
Brian Benzarti Medical Devices CLP Regulation Quality Assurance and Compliance Software Tools and Solutions 2
dgrainger Informational Medicines and Medical Devices Act 2021 UK Medical Device Regulations 0
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 5
dgrainger Informational MHRA - Regulating medical devices in the UK - Post Brexit - 2021-02 UK Medical Device Regulations 0
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
L Shelf life of medical devices Other Medical Device Related Standards 4
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
M Brexit The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 1
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Subcontracting a repair of Medical Devices Canada Medical Device Regulations 0
S Regrind Material in Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
N Medical Devices in oxygen rich environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Medical Devices Shelf Life ---INDIA Other Medical Device Regulations World-Wide 3
JoCam Warranty of Medical Devices EU Medical Device Regulations 2
R Obsolesce medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational UK - Medicines and Medical Devices Bill 2019-21 UK Medical Device Regulations 0
S Call it refurbish or not? Medical Devices Manufacturing and Related Processes 2
C Registering Medical Devices in Australia and New Zealand - ANZTPA Other Medical Device Regulations World-Wide 0
S Requirements for "Claims Guide" for medical devices Medical Device and FDA Regulations and Standards News 6
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5

Similar threads

Top Bottom