by admin | Apr 9, 2018 | Uncategorized
Following the industry meeting between SAHPRA (Medicines Regulatory Board of South Africa) and the Industry CEOs which MnandiPharma was present at, we can summarise the motion as a positive and supportive towards the newly founded companies in the industry as well as...
by admin | Apr 4, 2018 | Uncategorized
We are very pleased to introduce our Medical Device Classification module guide to welcome new parties into the industry and help them understand how devices are classified. MnandiPharma prides itself in pushing boundaries of previously unanswered norms of the...
by admin | Mar 29, 2018 | Uncategorized
We are very excited to welcome you to our newly refreshed web look. Taking it upon ourselves to spend valuable time to compare where we stand in the industry, as well as relooking at what the general feel is regarding regulatory compliance in the Medical Device...
by admin | Jul 2, 2016 | Uncategorized
Each package of an IVD shall have an instruction for use of the IVD that must contain the following information with regard to the IVD in at least English: Item Information to be supplied 1The name or trade name 2Name and address of the manufacturer 3The intended...
by admin | Jul 2, 2016 | Uncategorized
Information to be provided as Instructions for Use with the medical device or IVD, or on the packaging of each unit or on the packaging of multiple devices or IVDs. Instructions for the use of a medical device must be provided with the device. However, instructions...
by admin | Jul 2, 2016 | Uncategorized
Information to be provided with medical devices as a label where possible on the medical device or IVD, or on the packaging of each unit or on the packaging of multiple devices or IVDs The information mentioned in the following table must be provided with a medical...
