South Africa Class I Medical Device Accessory Registration

QM Becky

Involved In Discussions
#1
Good Day Everyone!
Quick question... I hope...
I have a Class I device accessory. It is purchased directly by the consumer. A consumer in South Africa has requested a purchase. Since it's not going through a distributor or rep in country, but shipping internationally, I"m a bit stumped as to what, if anything, is required.
Can anyone help me out?

Thank you!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
K Medical Device Regulations in South Africa - Company makes thousands of Products Other Medical Device Regulations World-Wide 1
Q South Africa Clinical Trial Inspections by MCC Quality Manager and Management Related Issues 1
B Combination Product South Africa CTD Other Medical Device Regulations World-Wide 1
M South Africa New Draft Regulations - Regulation Gazette No 37579, 22 April 2014 Other Medical Device Regulations World-Wide 2
T Importing Non-Electromedical Device (PACS Software) into South Africa Other Medical Device Regulations World-Wide 2
C Registration of Electromedical Device in South Africa Other Medical Device Regulations World-Wide 9
G Transfer of Import Licenses - Medical Device Regulations in South Africa Other Medical Device Regulations World-Wide 5
samer World Cup 2010 South Africa Coffee Break and Water Cooler Discussions 76
M Medical Devices Registering (Registration) Procedure in South Africa Other Medical Device Regulations World-Wide 4
M Certification Body in South Africa with experience certifying medical labs Registrars and Notified Bodies 5
A Looking for a third party to calibrate our measure equipment - South Carolina General Measurement Device and Calibration Topics 6
S Medical Device Product Classification in South Korea Other Medical Device Regulations World-Wide 1
E Recommendations for CBs south of England AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C Can a manufacturer (in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name? Other Medical Device Regulations World-Wide 1
E South Korea, MFDS - GMP inspections Other Medical Device Regulations World-Wide 4
J South Korea, MFDS - Medical Device Change Management Other Medical Device Regulations World-Wide 5
Y List of Cell therapy and Gene Therapy products in South Korea and China Other Medical Device and Orthopedic Related Topics 1
BradM Hurricane Harvey - Texas - August 2017 - Any South Texas Friends out there? Coffee Break and Water Cooler Discussions 10
K New South African Medical Device License Requirement? (Jan 2017) Other Medical Device Regulations World-Wide 6
L South of England - experienced Auditor / QMS looking for a new job Career and Occupation Discussions 1
S Korea - MFDS (South Korea Ministry of Food and Drug Safety) Contact? Other Medical Device Regulations World-Wide 4
E Medical Device Distribution Quality Management in South Korea Other Medical Device Regulations World-Wide 0
F Registration Process Guidance for Custom-Made Medical Devices in South/Latin America Other Medical Device Regulations World-Wide 11
U Language requirements - Software interface - Japan and South Korea Japan Medical Device Regulations 4
pittmatj South Korea - Custom Medical Device Regulations Other Medical Device Regulations World-Wide 1
S South Korea Ultrasound Software Requirements Other Medical Device Regulations World-Wide 1
E Upcoming changes for ISO 10993 and IEC 60601 in South Korea Other Medical Device Regulations World-Wide 2
Hershal Change in the South as I knew it back then Coffee Break and Water Cooler Discussions 3
V LEED Certification - South America Market Sustainability, Green Initiatives and Ecology 2
J Disinfectant Registration in Republic of Korea (South Korea) Other Medical Device Regulations World-Wide 2
C South Korean KFDA's KGMP Audit- Anyone with Firsthand Experience to share? Other Medical Device Regulations World-Wide 4
K South Korea IVD Medical Device Classifications Other Medical Device Regulations World-Wide 13
M South Korea Importing Rules for Privately Labeled Medical Devices Advice wanted Other Medical Device Regulations World-Wide 5
S Veterinary Diagnostic Kits Regulations in South East Asia Other Medical Device Regulations World-Wide 8
A Importing Sample Medical Devices into South Korea ISO 13485:2016 - Medical Device Quality Management Systems 2
J Medical Software Regulatory Requirements for South America and Middle East Other Medical Device Regulations World-Wide 3
B Regulatory Requirements for for Class IIa Electro Medical Devices for South America Other Medical Device Regulations World-Wide 4
Hershal Tornadoes in the South of the US - April 2011 Coffee Break and Water Cooler Discussions 18
C X-Ray Producing Product Regulations in Mexico, Central America, and South America Other Medical Device Regulations World-Wide 2
N Regulations for Registering Medical Devices in South Korea Other Medical Device Regulations World-Wide 6
S Regulatory Requirements for Telehealth or Telemedicine in South Korea Other Medical Device Regulations World-Wide 1
K Cosmetic Product Registration - South Korea Other Medical Device Regulations World-Wide 1
A Central/South America Regulatory Approval Other Medical Device Regulations World-Wide 8
D Lean System Effectiveness in South India Small and Medium Businesses Lean in Manufacturing and Service Industries 2
Howard Lee In South Carolina We Mean "Water Hazard" Coffee Break and Water Cooler Discussions 1
M Tips for my South West US vacation? Travel - Hotels, Motels, Planes and Trains 15
Marc Cable Breaks Disrupt Middle East and South Asia Internet Access After Work and Weekend Discussion Topics 0
J Isaac Hayes Quits 'South Park' Coffee Break and Water Cooler Discussions 17
T Movement of Auto Industry to the south in the US Career and Occupation Discussions 17

Similar threads

Top Bottom