Steps to enter the Medical Device, Dietary Supplements, and Cosmetics Market in Peru
Perú has over 33 million residents, and is a strong, developing market for foreign manufacturers. Our local industry does not satisfy our population demands and we depend heavily on import products mainly from China, US, India, Israel, Brazil, Colombia, among other industrialized countries.
DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), our market regulator, is responsible for the control and regulation of medical devices, IVD devices, medicines, biologics, dietary supplements, cosmetics, personal care products, and house cleaning products.
Imported products must be registered with DIGEMID before entering our market. Cosmetics registrations should be renewed every seven years, and all other products every five years.
Step One: Choose to do business locally or abroad
After years of helping manufacturers from all over the world, we’ve learned that most of them prefer to trust their registrations to us rather than a third party, such as a local distributor or importer. Few companies opt for opening a local office due to high fixed costs and complex local procedures. Despite the decision you make, Pharma Consulting is ready to fully support you regulatory compliance in our market.
Doing business locally
• Gives you almost full control of your operations in Peru
• Grants you the legal ownership of registrations
• Increases operations costs
• Involves time-consuming bureaucratic procedures
Running your business from abroad
• Gives you partial control of your local operations
• Allows you to mantain control of your registrations by means of a private contract
• Significantly reduces fixed costs
• Reduces time to market
Step Two: Define your local strategy
What is your business model for our market? Regulatory strategy is just a part of the bigger picture. Finding trustworthy local distributors, competing with our informal market and establishing long-lasting partnerships are among the most frecuent difficulties our clients face. Please, consider checking out this article by Ernst & Young covering commercial strategy consideratios for growth.
Registering an entire product portfolio may not be the best approach due to high market entry costs and effort. We advise our clients to narrow their focus to a small market, and start with market-leading products.
Step Three: Appoint your Peru Registration Holder
As your regulatory representative and registration holder, our task is to ensure a swift access to the Peruvian market. We will clarify the requirements outlined in local guidance documents and regulations, propose practical solutions to meet them, assess your technical and regulatory documentation, and elaborate fully compliant registration dossiers.
Step Four: Obtain registrations
We will outline a regulatory strategy for your products, and obtain the registrations in a timely and cost-efficient manner. As yout PRH we’ll keep you updated with relevant regulation changes. The registrations will remain always under your control.
Step Five: Market your products
After obtaining market clearance, your business will be ready to deploy a successful marketing strategy.
