Process to Market
The steps to getting your medical device to market.
Licensing
Import/Export
Distribution
Licensing
Import/
Export
Distribution
Licensing
There are three methods to achieve licensing. A product licensed through Mnandi Pharma, a license application compiled by Mnandi Pharma or we’ll assist you with Section 21 Authorisations.
Classification
Demonstration of Compliance
Submission Verification
Approval Declaration
Product Licensing
For when you would like to import and/or commercialise your own medical device product range.
In an instance where an international company or a start-up company would wish to enter the South African medical device market, without taking on the high risk of obtaining their own license, establishing a local premises and maintain their license in accordance with the regulations.
Mnandi Pharma is able to provide applicant/ hosting services as a long risk service to start-ups and international companies.
License Applications
For when you would like the ability to function on your own terms.
In an instance when a client would like to apply for their own license.
Mnandi Pharma is able to act as a host/applicant for their products and make sure that the product is compliant and all regulatory aspects are covered, as most clients do not understand the process and what needs to be in place , it becomes extremely complicated and expensive.
Section 21 Authorisations
For when you would like to import a medical device that may or may not be registered in an international jurisdiction. Mnandi Pharma is able to apply for a Section 21 Authorisation allowing the commercialisation of the product. We are able to achieve this through our proprietary information request checklist, internal reviewals and procedures. In an effort to provide the best possible chance of approval we work directly with manufacturers.
Import/Export of Licensed Products
Products Imported or Exported are to be licensed by a licensed Medical Device Establishment. Mnandi Pharma Solutions is able to administrate the import or export activities, even if it is licensed through someone else.
Our experience in regulated and scheduled substance logistics enables us to ensure your products move where they need to, and we will handle the paperwork.
It is the responsibility of the licensed Exporter to comply with the legal registration information approved by the relevant Ministry of Health of the importing country;
Distribution Administration
Structuring an efficient supply chain from manufacture to consumer is an essential step of product commercialization.
Strategizing which distribution facility to use will narrow down which wholesaler is available to supply to. Choosing an applicable distribution network is therefore crucial to ensure your product’s availability to your target market.
Our list of pre-approved distribution and wholesaling networks and our experience in supply chain logistics enables us to advise on the most effective service providers.
Our approach to distribution takes safety, security and professionalism as its main priority; ensuring your customers receive their orders on time, in expected condition and by a team who are fully compliant.
