Regulation of medical devices in Chile
Legal definition of Medical Device
Medical devices (“dispositivos medicos” in Spanish) are instruments, apparatus, applications, materials or articles , including software, used by themselves or in tandem, and defined by the manufacturer to be used directly on human beings, when the main expected action on the human body is not achieved by pharmacological, immunological or metabolic means, although those means can contribute to its function; with the propose of diagnosis, prevention, follow up, treatment or relief of sickness, damage or disability; of research or replacement or modification of the anatomy or of a physiological process or the regulation of conception. (Decree N˚ 825/98, article 2, n˚1).
According to the Sanitary Code and Decree 825/98, the regulation of medical devices will be done progressively, via specific Supreme Decrees signed by the Ministry of Health. This specific Decrees specify the devices’ Class and so the regulatory controls and requisites that apply to them.
Devices are divided into four different classes, that have different regulatory requirements. The class is determined by the Supreme Decree that submits the devices to regulation. The classes are the following:
Devices that have very low risk
Devices that have moderate risk
Devices that have an elevated risk potential
Devices considered critical risk
Only three kinds of devices are under mandatory regulation:
- Examination gloves, surgical gloves and condoms (Supreme Decree 342/2004)
- Hypodermic sterile single-use needles and syringes (Supreme Decree 1887/2007)
- Condoms (Supreme Decree 93/2018)
- Automated external defibrillator (Supreme Decree 42/2021)
According to article 3 of Decree 825/98, persons or companies that want at any title, to fabricate, import, commercialize or distribute medical devices need to obtain certification of the verification of conformity on the services, institutions, laboratories, or establishments that contain a specific sanitary authorization, emitted by the “Instituto de Salud Publica”, Public Health Institute, of Chile.
Regulatory Conditions to sell medical devices
Specific regulatory conditions for selling devices do not exist on the general regulations but can be imposed by the specific Supreme Decree that regulates the medical device. Of course, as for imports, to sell medical devices subject to mandatory regulation, a verification of conformity must be obtained from an accredited institution.
There are no specific requirements regarding manufacturers (except, following the definition, that they need to define the device as to be used directly on human beings) or Initial Importer (except to obtain the needed authorization, if the device is under mandatory regulation). However, the import process must follow the usual regulations for bringing items to the country and a certificate called CDA must be obtained at http://giconaweb.ispch.gob.cl/
However, due Covid-19 this process has been suspended for most of the medical devices until the Covid-19 alert has passed. Only the devices deemed critical such as x-ray equipment or defibrillator are exempt from this limitation
Advertisement of medical devices
There are no specific restrictions for advertisements regarding medical devices, though they could be imposed by Supreme Decrees regulating specific medical devices. However, there are restrictions on advertisements for pharmaceutical products, defined by the sanitary code and specific Decrees.
Producers and or importers take part in the process to avoid malfunctions and/or that these are being handled as soon as they happen. Each company has to appoint a person who will monitor the performance of the medical devices and maintain contact with the health authorities as well as the costumers.
An investigation must be made any time a malfunction is reported. This investigation as well as the measures to be taken and the final outcome must be informed to the health authorities (ISP). If needed, the medical devices shall be withdrawn from the market.
Also, a tendencies report and an annual report must be made by the producers and/or importers. They need to also have a system to be up to date about the international alerts regarding the products they sell.
Due to the lack of masks, authorities have allowed importing face masks without any special permit and/or certification, provided that the importer will only use those masks for his personal use of for his employees and make a swear statement when he imports those products for that purpose and that he will not resale them.
Last modified: 30/12/2021