Condoms - Commercialization in Chile

Currently, in Chile's regulations, there is no need for registration for medical devices except for a few cases. There are only 8 medical devices that must have mandatory registration in Chile, which are:

• Hypodermic needles complying with Decree No. 1,887
• Examination gloves complying with Decree No. 342
• Surgical gloves complying with Decree No. 342
• Hypodermic syringes with needles complying with Decree No. 1,887
• Single-use hypodermic syringes complying with Decree No. 1,887
• Condoms complying with Decree No. 342 and Decree No. 93
• Female condoms complying with Decree No. 93
• Portable Automated External Defibrillators (DEAs) complying with Decree 42

For products that do not require registration in Chile, we must obtain a Customs Destination Certificate (CDA), accompanied by the shipping document, commercial invoice, quality certificate, and a form that includes batch/serial numbers and expiration dates, if applicable.

Here is the information regarding latex rubber condoms:

INCORPORATES THE PRODUCTS INDICATED IN THE SANITARY CONTROL REGIME ESTABLISHED IN ARTICLE 111 OF THE HEALTH CODE AND SUPREME DECREE NO. 825, 1998, OF THE MINISTRY OF HEALTH

Exempt No. 93: Santiago, July 24, 2018.

"... incorporated into the sanitary control regime the following elements for medical use: single-use rubber surgical gloves, rubber gloves for medical examinations, and latex rubber condoms."

"... verification of compliance with medical devices consisting of latex rubber condoms, incorporated by exempt decree No. 342, 2004, was carried out using the technical standards contained in Standard NCh 2224/1-2224/10of93, which have expired and it is necessary to accept the internationally valid version up to that point, which incorporates aspects related to primary packaging integrity, stability, incompatibility, and microbiological contamination studies."

"... The said document also informs that exempt decree No. 342 defines mandatory control only for latex rubber condoms but does not include synthetic male condoms (nitrile, polyurethane, etc.) or female condoms, which is why the latter are not subject to sanitary control. The report also adds that it confirmed the technical and operational feasibility of the authorized certifying body to perform the analyses required by the new proposed standards."

The products and elements for medical use listed below are incorporated into the control system established by Article 111 of the Sanitary Code and its regulations, approved by Supreme Decree No. 825, 1998, of the Ministry of Health:

The conformity assessment of these products must be conducted in accordance with the technical standards and specifications indicated and approved by this administrative act and the class assigned to them:

• Condoms - Natural Latex Male Condoms ISO UNE EN 4074:2016 Standard; Class III.
• Condoms - Synthetic Male Condoms ISO No. 23409 "Male condoms - Requirements and test methods for condoms made of synthetic materials"; Class III.
• Condoms - Female Condoms ISO 25841 "Female Condoms - Requirements and test methods"; Class III.

The above products can only be manufactured, imported, marketed, or distributed in the country if they have the corresponding certification of compliance with the applicable standards, granted by an entity authorized by the Institute of Public Health for this purpose.

?*Schedule a meeting at MEDICA Düsseldorf, Germany, November 13 – 16, 2023.

*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br.