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Strategic Regulatory Partner for Success in Chile

Greetings from

Pharma Wizard Chile

Being one of the prosperous countries in South America, Chile attracts medicinal products and medical device manufacturers to invest in the region not only for its strong healthcare system, but also for modern technologies that are being implemented. To access the market, manufacturers must obtain market approvals and registrations from the Agencia Nacional de Medicamentos (ANAMED). With ever-evolving Regulations and competitive timelines, Chilean market, however, challenges foreign manufacturers to navigate the updated Regulatory procedures to fall in compliance.

As a proven global Regulatory partner, Pharma Wizard assists foreign manufacturers with proficient Regulatory affairs consulting: right from decoding necessary regulations to preparing audit-ready dossiers and submitting them to concerned authorities for in-time market approvals. Pharma Wizardā€™s Regulatory services in Chile span across:
  • Medical Devices
  • Drugs

Industries We Serve in Chile

  • Food Supplements
  • Medical Devices
  • Drugs

Food and Dietary Supplements Registration Chile

Navigating the regulatory landscape for food and food supplements in Chile requires expertise and precision. Pharma Wizard offers comprehensive regulatory support to ensure your products meet Chile’s stringent registration requirements.

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food supplements registration

Medical Decives Registration

The regulation of medical devices in Chile is risk-based, following a classification system aligned with international standards (Class I to IV). Not all devices require registration:

  • Class I (low risk) devices generally do not require registration but must comply with relevant safety and performance standards.
  • Class II, III, and IV (moderate to high risk) devices must be registered with ISP.

For registration, manufacturers must provide technical documentation, labeling, evidence of safety and performance, and proof of compliance with international standards or prior approval from reference regulatory authorities (such as FDA, EMA, or ANVISA).Ā The registration timeline varies based on device class and documentation quality but generally ranges from 6 to 12 months. A local representative or legal agent is required for foreign manufacturers.

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medical devices registration, labeling

Drugs Registration in Chile

Registration is mandatory for all pharmaceutical products, including prescription drugs, over-the counter medications, biologicals, and vaccines. To obtain a Marketing Authorization Registro Sanitario, applicants must submit a complete dossier to ISP, which includes:

  • Administrative documents e.g., applicant details, certificates of pharmaceutical product
  • Chemical, Manufacturing, and Controls (CMC) data
  • Preclinical and clinical data to demonstrate safety and efficacy
  • Labeling, packaging, and patient information leaflet details

The registration process can take approximately 12 to 18 months, depending on the completeness of the submission and the type of product. Once approved, the marketing authorization is valid for five years, after which it must be renewed.

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Pharmaceuticals

Pharma Wizard Capabilities

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory Intelligence
  • Registration pathways and license management services
  • Dossier Management

Pharma Wizard Advantages

  • Strategic and well-versed local regulatory knowledgebase ā€“ with medical device, Regulatory health authority
  • Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines

Looking for Regulatory Support in Chile

Contact us now for Expert Guidance and Support

Send Us a Request