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 accommodative for the current businesses. Continue reading “Medical Device Industry meeting – SAHPRA & Industry CEOs”
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 industry, just as the regulation itself breaks away from the Medicines regulations.
Please feel free to try it out as many times as you please, however, we do disclaim that it is purely for educational purposes and does not claim to stand any authority whatsoever. The module is based purely on the guidelines.
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 industry; we’re confident we’ve nailed it.
We hope you like our new look as much as we do, and should you have any opinions thereof, please let us know!
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: Continue reading “Instructions for use for an IVD”
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 for the use of a medical device need not be provided with the device or may be abbreviated, if:
- the device is a Class A medical device and
- the device can be used safely for its intended purpose without instructions.
Instructions for the use of a medical device must include information mentioned in the following table that is applicable to the device.
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