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?
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