If you have any questions about a pending return, go back to the main page or home page and in "Contacts and Networks," you will find the Contact Form available for direct communication with us. If you want to generate a PQRS (Request / Complaint / Claim / Suggestion), please use the appropriate channel via this link: https://pqrs.puramas.co
1. OBJECTIVE
Ensure the proper functioning of the medical device and/or product return process marketed by Avimex de Colombia S.A.S. through the execution of operations established by the company, ensuring support and solutions to our customers' needs.
2. SCOPE
This procedure applies from the return request issued by the client until the return status is updated, presenting all the corresponding stages for the solution of the return, including necessary measures to maintain quality conditions. It applies to medical devices and/or products marketed by Avimex de Colombia S.A.S.
3. RESPONSIBLE PARTIES
Planning is the responsibility of the Technical Director (responsible for disseminating and enforcing this procedure).
Execution is the responsibility of the Sales Director, Accounting Assistant, Logistics Assistant, and Quality Assistant. Monitoring is the responsibility of the Quality Assistant.
4. DEFINITIONS
Warehouse: It is the place where medical devices are stored, ensuring adequate temperature and humidity conditions.
STORAGE: Storage involves the provisional accumulation of reserves. This process includes activities such as placement, maintenance, control, completion, evidence, and delivery of reserves.
Quality: The totality of the traits or characteristics that support the ability of a medical device to meet its fitness for use, including safety and performance. The degree to which a set of inherent characteristics meets the requirements.
Classification: It consists of the dichotomous process of distinguishing objects with certain characteristics from those without and grouping them into a class.
Client: Organization, entity, or person who receives a product and/or service.
Compensation: It is the balancing of one action or characteristic with another opposing, yet of similar importance.
Closure: The culmination of the process and its development balance.
Critical Defect: It is one that severely and inadmissibly affects the quality and safety of the product's use, preventing its normal functioning or performance. The product is unusable.
Quality Defects: Any physical or chemical attribute or characteristic of the medical device that is against the specifications with which it was manufactured and authorized by INVIMA in the sanitary registration.
Major Defect: A defect that, while not critical, has the potential to cause failure or materially reduce the product's utility. The product's utility is considerably reduced.
Minor Defect: A defect that reduces the product's utility very little or causes a small deviation from established requirements with a minor effect on the product's functioning or effective use. The product's utility is barely reduced.
Return: It is the process through which a customer who has purchased merchandise returns it to the store and receives a refund or, in some cases, another item or store credit.
Medical Device: An instrument, tool, machine, testing device, or implant used to prevent, diagnose, or treat disease or other conditions.
Document: Information and its medium of support (can be digital and/or physical).
Specifications: A document that details the conditions that medical devices or materials used or obtained during manufacturing must meet until the finished product is obtained. Specifications serve as the basis for quality evaluation.
Evaluation: The attribution or determination of the value of something or someone. Evaluation of knowledge, attitude, and performance of a person or service.
Functional Failures: Malfunction or deterioration in the characteristics and/or performance of a medical device, which may have led to death or deterioration of health.
Warranty: "Temporary obligation, solidarity of the producer and supplier, to respond for the good condition of the product and its conformity with the legally required or offered conditions of suitability, quality, and safety."
Importer: Any natural or legal person who brings medical devices into the national territory for commercialization purposes, regardless of whether they are also a user of these products.
Raw Material / Inputs: Raw materials are all materials mainly extracted from nature and form the basis of a product. Inputs are processed elements that help develop a final product or service.
Non-compliance: Failure to meet a requirement. It can be a deviation from standards, practices, work procedures, applicable regulatory requirements, among others.
Credit Note: It is a legal document used in transactions where there is a subsequent discount after issuing the invoice, a total cancellation, a charge for an incurred additional expense, or the return of goods.
Process: A set of mutually related or interacting activities that transform input elements into results.
RECEPTION: It corresponds to the point of ownership transfer between a supplier and a client. It is an important control stage to ensure the conformity of the goods before their integration into the company's inventory.
REFUND: To return an amount to the person who had disbursed it.
Reference: A qualitative or design variant of a product, used for the same purpose, corresponding to the same holder and manufacturer. At Avimex de Colombia S.A.S., references generally coincide with the last 4 digits of the associated barcode.
Record: A document that presents obtained results or provides evidence of executed activities.
Review: An activity undertaken to ensure the convenience, adequacy, effectiveness, efficiency, and success of the reviewed subject in order to achieve established objectives.
Validation: Confirmation through the provision of objective evidence that the requirements for a specific intended use or application have been met.
5. LEGAL FRAMEWORK
DECREE 4725 26-12-2005: Regulates the regime of sanitary records, commercialization permits, and sanitary surveillance related to the production, processing, packaging, storage, sale, use, importation, marketing, and maintenance of medical devices.
RESOLUTION 4002 2007: Adopts the Manual of Requirements for Storage and/or Conditioning Capacity of Medical Devices.
Resolution 4816 2008: Regulates the National Technovigilance Program based on the following: articulation between the actors of the National Technovigilance Program / truthful, timely, and confidential information / continuous training and information for the involved actors / traceability of medical devices / sensitivity and representativeness.
Resolution 1319 2010: The purpose of this resolution is to adopt the Manual of Good Manufacturing Practices for the elaboration and adaptation of custom-made medical devices for orthopedic prostheses and external orthotics, specifying the machines, equipment, tools, and instruments required by establishments that manufacture and adapt such devices.
Art. 47 Law 1480 of 2011: The right of every consumer to return a product purchased or a service contracted and request a refund of the full amount paid, without providing explanations or waiting for the seller's consent.
ASS-AYC-FM063: Defines the checklist of CCAA requirements (Good Storage and Conditioning Practices) for medical devices. (Version: 04, Issue Date: 19/01/2024).
Resolution 2968 of 2015: Establishes the sanitary requirements that establishments producing and adapting custom-made external orthopedic devices must comply with.
6. RELATED DOCUMENTS
020-LOG-P-Recepcion-Inspeccion.docx: Manual of Objects, Scope, Responsibilities, Definitions, Legal Framework, Procedures related to the reception of products, raw materials, inputs, components, and medical devices entering the organization.
020-LOG-R-Recepción-Inspección: Form used for receiving purchases, returns, adjustments, audits, and complaint evaluations.
001-AVX-P-Empresa-Calidad.docx: Establishes the quality standards developed within the company, reflected in each process.
022-CAL-D-Devoluciones.xslx: Document for recording return requests, considering their condition.
022-LOG-P-Devoluciones.docx: Return procedure, establishing guidelines and generalities for executing the process.
092-TEC-P-RetiroMercado.docx: Market withdrawal procedure in any case where a health alert is issued.
7. PROCEDURE
RETURN POLICY
At Avimex de Colombia S.A.S, we want to ensure that you are completely satisfied with your purchase. To do so, we provide the following information to facilitate the return process:
To make a return, the customer must clearly identify the reason for the return, in order to maintain controls and improve our services.
At the time of making the return, the required data must be provided to make it effective. This information will be entered into a PQR form.
Returned products must be in their original condition, with no modifications or characteristics other than those of the product.
To make the return, the purchase invoice must be attached.
The customer must express their claims at the time of the return, which will be processed within a maximum of 30 days from the moment the product is received.
Customers wishing to make returns must contact our salespeople and Merchandisers. They can also process the return through the following channels: +573156434807, email at ventas.internet@avimex.co, or via our social media platforms.
When products arrive at the store, they are inspected to verify the information provided by the customer. This inspection is recorded in the reception and technical inspection form, where criteria set by the company are evaluated, determining the product's quality status (approved, quarantined, or rejected).
The customer may request a refund, replacement with a new product, changes, or cancellation of the delivery note as appropriate.
WARRANTY POLICY
Our goal is your satisfaction and to ensure the quality of the products. Therefore, we provide the following information regarding how to apply and request the warranty process.
Warranty applies in the following cases at Avimex de Colombia S.A.S:
° If you received a product with manufacturing defects or in poor condition.
° If the product does not meet its purpose, works incorrectly, or is incomplete.
° If the product is damaged due to transportation during shipping.
° If the product prematurely wears out under normal use conditions.
° If the product’s performance does not meet your expectations and you are dissatisfied.
Warranty will not be recognized in the following cases:
° If the product has been used incorrectly, abusively, or negligently.
° If the product has been modified without authorization.
° If the product’s usage instructions have not been followed.
° If the product has undergone normal wear and tear.
° If the product has been used with chemicals that damage or affect its function.
° If an uncontrollable event occurs (natural disasters, floods, vandalism, pest or rodent damage, etc.) after the product is in the user’s possession.
° If the product has been handled (e.g., accessories, manufacturing) by companies other than Avimex de Colombia S.A.S.
General Warranty Information at Avimex de Colombia S.A.S:
° Avimex de Colombia S.A.S guarantees 100% warranty.
° Shipping and collection costs for warranty products are covered.
° Avimex de Colombia S.A.S strives for customer satisfaction and will take actions to support our customers.
° Avimex de Colombia S.A.S offers discounts or bonuses for warranty claims, which will be determined by the company.
° The customer has up to 6 months from the product delivery date to request the warranty.
° The customer must clearly and respectfully express their reason for dissatisfaction and warranty request.
° The customer must clearly define their expectations at the time of the warranty request.
° Avimex de Colombia S.A.S reserves the right to update the terms and conditions of this policy.
Warranty Process at Avimex de Colombia S.A.S:
° You can request the warranty through the company’s established customer service channels.
° Salespeople and Merchandisers are the main contact for returns and warranties.
° Online sales channels: Social media (Instagram, X, Facebook), website, phone, WhatsApp +573156434807, email: ventas.internet@avimex.co.
° In-person at our offices located at Carrera 80C N°32EE-28, Laureles neighborhood (Medellín, Colombia).
° The customer must provide complete and detailed information when making the warranty request, which will be required by the customer service channels.
° The product subject to warranty must be submitted along with the purchase invoice or identification of the buyer.
° Once the product is received, it will be sent to the quality department for inspection. Based on the analysis, the warranty will be processed internally.
° The customer may request a refund, product replacement, changes, or cancellation of the delivery note.
° The estimated time for receiving and reviewing the warranty is 15 business days from the complaint or claim.
