The document must meet the following requirements:

1. It must be issued by the health authority of the country of origin or a reference country (Canada, Japan, Australia, the European
Union or the United States). 2. You must indicate the name of the manufacturer, the name of the medical device or Biomedical
1. FREE SALE CERTIFICATE Equipment with its references that you wish to protect. 3. If the CVL does not declare the validity, it will be one (1) year, which will
(imported products) be taken from the date of its issuance and if not, the validity that the document contains. 4. It must be apostilled if the country is
within the hague convention. 5. It must be accompanied by the official translation.

This document must meet the following requirements:

2. MANUFACTURER
AUTHORIZATION (imported 1. Indicate the name of the importer with his address.
products) 2. Indicate the roles and activities that the new importer will perform in the sanitary registry in accordance with current sanitary
regulations.
3. It must be signed and authorized by the holder of the sanitary registration and / or marketing permit.

The description should contain: indications, contraindications, warnings, main components, accessories, relationship with
patients; everything in Spanish.
3. DESCRIPTION OF THE
MEDICAL DEVICE
Remember that the commercial presentation corresponds to the definition of the number of units / content per package / container
as the manufacturer and / or importer markets the product to the market and is authorized in the sanitary registry.

A) Summary of design verification and validation documents (test report during manufacturing process)
4. TECHNICAL STUDIES
AND ANALYTICAL CHECKS B) Certificate of analysis of the finished product that contains the specifications, indicating the values or ranges of acceptance. It is
required to establish that the design complies with the specific technical regulations and standards in force for them.

5. DECLARATION OF When the Certificate of Free Sale - CVL only declares the families of the references, the interested party must present the
CONFORMITY ISSUED BY Declaration of conformity of the manufacturer indicating that under the name of the families described in the CVL are the
THE MANUFACTURER subfamilies of the references , which It must coincide with those indicated by the interested party in the application form.
 Indicate the method or methods used with your procedure, the reference standard on which it is based and the studies carried out,
6. STERILIZATION METHOD results and conclusions. In case the method of sterilization of the product is carried out with ethylene oxide , the studies that
demonstrate the post-sterilization residue of this must be attached.

For sterile Medical Devices from the factory or non-sterile products that declare the useful life, this requirement is understood to
7. SHELF LIFE have been fulfilled by attaching the stability studies that allow validating the attributed useful life, attaching a summary of the
(When applicable) method and procedure applied, verification, validation and final result. In the case of products that do not declare the useful life,
a manufacturer's declaration will not be required .

Must be attached tests evolution biological product (cytotoxicity studies, toxicity system , pathogenicity , sensitization , irritation or
reactivity intercutánea , genotoxicity, allergenicity , hemo compatibility and carcinogenicity) by device, these applied for
8. SCIENTIFIC which are in direct contact with the patient and on them attach the summary of the studies and tests carried out. When they
INFORMATION are sufficiently proven technologies , this requirement can be met by providing scientific evidence that is indexed or published in
SUPPORTING THE SAFETY world-renowned journals in which the biological evaluation of the specific material for the medical device that is the object of the
OF THE MEDICAL DEVICE health registration application is related.
risk IIa , IIb and III
For active medical devices (that depend on an energy source for their operation), you must provide scientific information that
supports the safety of the Medical Device risk IIa , IIb and III. For which the development of electrical and electromagnetic
compatibility tests (example: IEC Standards) must be attached, in accordance with current international regulations.

9. RISK ANALYSIS ISSUED

BY THE MANUFACTURER It should be mentioned the risks detected during design and manufacturing, causes, severity, occurrence, detectability , solutions
FOR MEDICAL DEVICES proposed for the mitigation of each one of them.
class IIa , IIb and III

10. LIST OF STANDARDS

Indicate in the list the international reference standards applied totally or partially if applicable.
EMPLOYED

11. COMMERCIAL HISTORY

Reference the countries in which the medical device is sold and indicate the Health Alerts involved with the medical device that is
OF THE MEDICAL DEVICE
the object of the Health Registry request. (Issued by the manufacturer of the product)
(Imported products)