Medical Device Registration in Chile: ISP Regulations and Compliance

Regulatory Authority

ISP (Instituto de Salud Pública or Public Health Institute)

The Institute of Public Health of Chile (ISP) is a public service with management autonomy and legal personality, relying on the Ministry of Health for policy approval and execution. Its mission is to promote and protect population health by strengthening health control through surveillance, authorization, inspection, research, and technological transfer. The ISP focuses on quality, safety, effectiveness, and innovation, with a gender, territoriality, and intercultural focus.

Strategic objectives include ensuring the quality, safety, and effectiveness of health control products, strengthening technical capacities of related organizations, and generating reliable information for decision-making. Knowledge management, applied research, and innovation are also emphasized.

The ISP also aims to improve institutional processes through continuous improvement, standardized work methodologies, and efficient communication. It also strengthens the integrated model of customer management, administration, and finance.

Institutional values include commitment, respect, and integrity. The ISP values responsible officials who practice open communication and responsibility for their duties.

Link for Regulatory Authority

https://www.ispch.cl/

Local Regulation

Reglamento de control de productos y elementos de usomédico

Classification of Medical Devices

Class I, II, III, IV

Listing or Registration Requirements

Only four types of medical devices are subject to mandatory registration contraceptives, gloves, needles, and syringes. Other medical equipment and devices do not need regulatory registration. X-ray equipment and nuclear medicine equipment needs special authorization from other government agencies, but not from ISP-ANAMED.

Documents Required for Chile Medical Device Registration

• CE certificate
• QMS certificates
• Labels
• A Free Sales Certificate or export certificate from the manufacturer’s country of origin.
• Quality system certifications (medical device and manufacturing plant).
• Letter authorizing a local entity in Chile to be the manufacturer’s distributor and IOR.
• Risk management report (Class III and IV).
• Biocompatibility report (Class III and IV).
• Declaration of sterility, method, and validation certificate (applicable for sterile medical devices).
• Certification of electrical safety according to IEC 60601 (if applicable).
• The implant card (if applicable).
• Letter stating the manufacturer’s commitment to providing local post-sale technical support, including replacement parts
• Labels (originals and their Spanish translations), instructions for use (IFU).
• Any promotional material.
• The qualitative and quantitative composition (if applicable).

Registration Timeline

• Class I (low risk): 2-3 months
• Class II (moderate risk): 3-6 months
• Class III (high risk): 6-12 months
• Class IV (critical risk): 12+ months.

Registration Fees:

In Chile, the Instituto de Salud Pública de Chile (ISP) oversees the registration and regulation of medical devices. The government fees associated with various registration and authorization processes are outlined in the ISP’s Catálogo de Prestaciones. Below are some pertinent fees: 

• Sanitary Registration of Medical Devices: CLP 160,027 + VAT 

• Sanitary Registration of In Vitro Diagnostic Medical Devices: CLP 471,382 + VAT 

• Modification and/or Update of Medical Device Registration Details: CLP 66,977 + VAT 

• Authorization for Installation, Operation, or Modification of Medical Device Storage Warehouses: CLP 880,747 + VAT 

• Registration of Manufacturers and/or Exporters, Importers, and/or Distributors Along with the List of Commercialized Medical Devices: CLP 301,386 + VAT 

• Request for Review of Background Information Accompanying Medical Devices: CLP 471,382 + VAT 

• Declaration of Regulatory Status of Medical Devices: CLP 32,373 + VAT 

• Authorization of Importation, Sale, or Provisional Use of Medical Devices Without Verification of Conformity in Other Qualified Cases: CLP 78,137 + VAT 

For a comprehensive list of services and associated fees, you can consult the ISP’s Catálogo de Prestaciones available on their official website. 

Please note that these fees are subject to change, so it’s advisable to verify the current rates directly with the ISP before proceeding with any application.

License Validity

Licenses issued in Chile are valid until the expiry of the device’s FSC

Special Labelling Requirements

Labelling and descriptions in Spanish

Additional Comments 

All medical devices, not just contraceptives, gloves, needles, and syringes, require mandatory registration with the Chilean Institute of Public Health (ISP) before being marketed and distributed within the country. The level of scrutiny and documentation needed for registration depends on the device’s classification based on risk. 

While X-ray and nuclear medicine equipment may involve additional authorizations from other agencies like the Nuclear Energy Commission (CCHEN), they still require registration with the ISP. 

It is important to remember that ANAMED is the former name of the ISP, which currently operates under the official acronym ISP and handles all medical device regulations, including registration for all equipment types. Remember, regardless of equipment type or complexity, registration with the ISP serves as a cornerstone of medical device regulations in Chile.

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk