Medical Devices Registering (Registration) Procedure in South Africa

Hi Friends

Is there any experts know that what is the direction to register medical devices in the South Africa Market? Especially for medical devices product listing within the government of South Africa.

Thanks in advance

Re: Help - Medical Devices registering procedure in South Africa

I would suggest you contact one of my colleagues Simone Shortt in SA. If she doesn't know, no one does. Her business is Reg and QS in SA.
I will let her know you may contact her.
Christine

Re: Help - Medical Devices registering procedure in South Africa

Medsearch said:

Hi Friends

Is there any experts know that what is the direction to register medical devices in the South Africa Market? Especially for medical devices product listing within the government of South Africa.

Thanks in advance

Click to expand...

Refer attached ITA document

Regards
S. Subramaniam

Re: Help - Medical Devices registering procedure in South Africa

I am certainly not an expert, but do live in South Africa.
It seems that the Act involved is the - SOUTH AFRICAN MEDICINES AND MEDICAL DEVICES REGULATORY AUTHORITY ACT 132 OF 1998.
Your first contact should probably be the Medicines Control Council - http://www.mccza.com.
I am sure a search of www.info.gov.za or www.doh.gov.za would help. Try this link http://agric.ncape.gov.za/dept/ActsVet/98-132Act132of1998MedicinesMedicaldevices.doc.
Having dealt with the SA government and parastatals - I would strongly suggest that if you are not resident in SA, get a consultant to help - like Med Reg.

I have helped clients register in Africa.

If you are still looking for a professional regulatory consulting firm, I would suggest finding a good qualified consulting firm with experience..