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.

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.

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.

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. 

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.

After obtaining market clearance, your business will be ready to deploy a successful marketing strategy.

In Peru, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) is the National Authority that oversees the medical devices, equipment, pharmaceutical products, personal care, and health products market.

Is it necessary to obtain authorization to operate as a company prior to marketing restricted products?

Yes, according to Bill No. 29459 of 2019, in Peru, companies must register as a pharmaceutical establishment called drogueria with the General Directorate of Medicines, Supplies, and Drugs, before starting the importation and distribution of products. Alternatively, foreign companies that do not wish to operate locally in Peru can contract the services of a registration holder as Pharma Consulting who will act as their representative before our national authorities.

Is it necessary to obtain prior authorization for the marketing of medical equipment, pharmaceutical products, and other health products?

Yes, Bill No. 29459, Supreme Decree No. 016-2011-SA and its amendments establish that, in Peru, companies must have prior authorization for their products, which can be a registration in the case of medical equipment, devices, and pharmaceuticals or a mandatory health notification (NSO) for cosmetics and personal care products.

Are there import controls for medical equipment, devices, pharmaceuticals, or health products?

Yes, Peruvian Customs restricts the entry of medical equipment, devices, medicines, cosmetics, personal care, and other products established in Supreme Decree No. 016-2011-SA, Supreme Decree No. 001-2012-SA, and its amendments. Only companies holding a registration, a current mandatory health notification, or a certificate of these titles are authorized to import this type of product.

Is there a post-market surveillance system in Peru?

Yes, Peru has a Pharmacovigilance and Technovigilance system, established by Supreme Decree No. 013-2014.

Are international standards used to regulate the pharmaceutical market?

Yes, the Regulatory Authority in Peru evaluates the quality and safety parameters of medical equipment, devices, drugs, cosmetics, and other restricted products, taking as reference international standards such as ISO standards, standards published by the FDA, and regulations of the European Community and others of international recognition.

In Peru, only companies registered as droguerias or laboratories can import and distribute medical equipment and devices, medicines, cosmetics, personal care products, and other health products. Alternatively, foreign companies can designate a registration holder to represent them before the Peruvian authorities.

Establishments that sell medical equipment and devices, medicines, and health products must have an operating authorization granted by DIGEMID prior to importing, storing and distributing products.