The Medical Control Council held a workshop last week in respect of the new legislation for medical devices and IVDs.
Initially the companies and organisations who need to comply will be required to apply for a licence. Only later will they registration of products take place.
You will either need a licence to manufacture or a licence to distribute – if you do not manufacture the product.
There is a list of documents and criteria that need to be supplied when you apply for your licence, including proof of ISO 13485 compliance. If you need any help, please contact me.