Karen M, one of our Switzerland-based consultants, recently shared her insights into emerging markets of medical device with us. Here are Karen’s five tips to consider before sending your product to a new or developing market:
Understand existing regulations
Regulations may vary from country to country
When using the Common Technical document (CTD) format, be sure to address the country specific requirements in Module 1
Regulations vary for the type of product (i.e. new molecular entity, generic, biosimilar, medical devices, vaccines, etc.)
Understand the WHO Certification on the Quality of Pharmaceutical Products Moving in International Commerce (CPP Scheme)
From which countries will CPPs be accepted for registration?
What is the cost?
What is the validity?
Understand the approval process
The time frame can vary from country to country
Is it necessary to have an agent or other authorized person present in the country to interact with the regulatory authorities?
Understand the competition and need for marketing as well as pricing and distribution practices
Is there a medical need for this product to be marketed?
How will this product be priced?
Is there an adequate distribution network?
Understand the business aspects as well as the regulatory aspects
How will the product be advertised/promoted?
Who will market the product in a particular country and is there an adequate sales force?