1. OBJECTIVE
Guarantee the optimal functioning of the return process for medical devices and/or products marketed by Avimex de Colombia S.A.S. through the execution of operations established by the company, ensuring that we provide support and solutions to the needs of our clients.
2. REACH
This procedure applies from the return request issued by the customer to the update of the status of the return, presenting all the corresponding stages for its solution, and concerns the necessary measures to maintain quality conditions. Applies to medical devices and/or products marketed by Avimex de Colombia S.A.S.
3. RESPONSIBLE
Planning is the responsibility of the Technical Director (responsible for publicizing and enforcing this procedure).
The execution is the responsibility of the Sales Director, Accounting Assistant, Assistant
Logistics and Quality Assistant. Monitoring is the responsibility of the Quality Assistant.
4. DEFINITIONS
WAREHOUSE: It is the place where medical devices are kept or stored, guaranteeing adequate temperature and humidity conditions.
STORAGE: Storage consists of the provisional accumulation of reserves. Within this process, activities such as placement, maintenance, control, completion, evidence and delivery of reserves are distinguished.
QUALITY: Totality of features or characteristics that support the ability of a medical device to satisfy fitness for use including safety and performance. Degree to which a set of inherent characteristics meets requirements.
CLASSIFICATION: It consists of the dichotomous process of distinguishing things or objects that have a certain characteristic from those that do not have it and grouping them into a class.
CUSTOMER: Organization, entity or person that receives a product and/or service.
COMPENSATION: It is balancing an action or characteristic with another opposite one, but of similar importance.
CLOSING: Completion of the process and development of its balance sheet.
CRITICAL DEFECT: It is one that seriously and unacceptable affects the quality and safety of use of the product, and prevents its operation or normal performance. The product is not usable.
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 health registry.
MAJOR DEFECT: A defect that, without being critical, has the probability of causing a failure or materially reducing the usefulness of the product for which it was intended. The usefulness of the product is considerably reduced.
MINOR DEFECT: A defect that reduces the usefulness of the product very little, or that produces a deviation from the established requirements with a small reducing effect on the operation or effective use of the product. The usefulness of the product is very little reduced.
RETURN: It is the process by which a customer who has previously purchased merchandise returns it to the store and in exchange, receives cash for return or, in some cases, another item or a credit to use in the store.
MEDICAL DEVICE: Instrument, tool, machine, test implement, or implant used to prevent, diagnose, or treat disease or other conditions.
DOCUMENT: information and its support medium (can
be digital and/or physical).
SPECIFICATIONS: document that writes
in detail the conditions that the medical devices or materials used or obtained
during manufacturing must meet, until the finished product is obtained. The
specifications serve as a basis for quality evaluation.
EVALUATION: attribution or determination of the
value of something or someone. Assessment of knowledge, attitude and
performance of a person or a service.
MALFUNCTION: malfunction or
deterioration in the characteristics and/or performance of a medical device,
which could have led to death or deterioration in health.
GUARANTEE: “temporary, joint
obligation on the part of the producer and the supplier, to respond for the
good condition of the product and its conformity with the conditions of
suitability, quality and safety legally required or those offered.”
IMPORTER: any natural or legal person who brings
medical devices into the national territory for marketing purposes, without
considering whether he or she is also a user of said products.
RAW MATERIALS / INPUTS: raw materials are all
those materials that are mainly extracted from nature and that constitute the
basis of some product. Inputs are already processed elements that help develop
a final product or service.
NON-CONFORMITY: non-compliance with a
requirement. It may be a deviation from standards, practices, work procedures,
applicable regulatory requirements, among others.
CREDIT NOTE: it is a legal
document that is used in transactions where a discount is involved after the
invoice is issued, a total cancellation, a charge for an extra expense incurred
or the return of goods.
PROCESS: set of mutually related or interacting
activities, which transform input elements into results.
RECEPTION: corresponds to the point of transfer of
ownership between a supplier and a customer. It is an important control stage
to guarantee the conformity of the merchandise before its integration into the
company's stocks.
REFUND: return an amount to the person who had
disbursed it.
REFERENCE: qualitative or design
variant of a product, used for the same use and corresponding to the same owner
and manufacturers. At avimex de colombia s.a.s. references generally match the
last 4 numbers of the associated barcode.
REGISTRATION: document that
presents results obtained or provides evidence of activities carried out.
REVIEW: activity undertaken to ensure the suitability,
adequacy, effectiveness, efficiency and effectiveness of the subject matter of
the review, to achieve established objectives.
VALIDATION: confirmation by providing objective
evidence that the requirements for a specific intended use or application have
been met. Validation.
5. LEGAL FRAMEWORK
DECREE 4725 12-26-2005: Regulates the regime of health records, marketing permits and health surveillance in relation to the production, processing, packaging, storage, sale, use, import, marketing and maintenance of medical devices.
RESOLUTION 4002 2007: Adopts the Manual of Requirements for Storage Capacity and/or Conditioning of Medical Devices.
RESOLUTION 4816 2008: By which the National Technovigilance Program was regulated based on the following: articulation between the actors of the National Technovigilance Program / True, timely and confidential information / Training and permanent information of the actors involved / 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 development and adaptation of medical devices for measuring prostheses and external orthopedic orthoses, indicating the machines, equipment, tools and instruments that they must have. establishments where custom-made medical devices for prostheses and external orthopedic orthoses are manufactured and adapted.
Art. 47 Law 1480 of 2011: The withdrawal is the right that every consumer has to return a product they purchased or a service they contracted and request a refund of 100% of the money paid, without giving explanations or waiting for the seller to agree. or allow it.
ASS-AYC-FM063: Defines the checklist of CCAA (Good Storage and Conditioning Practices) requirements for medical devices. (Version: 04, Issue Date: 01/19/2024).
RESOLUTION 2968 OF 2015: Which establishes the health requirements that must be met by establishments that manufacture and adapt medical devices based on external orthopedic technology located in the national territory.
6. RELATED DOCUMENTS
020-LOG-P-Recepcion-Inspeccion.docx: Manual of Objects, Scope, Responsible Persons, Definition, Legal Framework, Procedures linked to the reception of products, raw materials, supplies, components and medical devices that enter the organization.
020-LOG-R-Reception-Inspection: Format used to receive purchases, returns, adjustments, audits and evaluation of complaints.
001-AVX-P-Company-Quality.docx: Establishes the quality standards that are developed in the company, which is reflected in each process.
022-CAL-D-Devoluciones.xslx: Registration document for requested returns, taking into account their status.
022-LOG-P-Devolutions.docx: Returns procedure, establishes the guidelines and generalities for the execution of the process.
7. PROCEDURE
RETURN POLICY
At Avimex de Colombia S.A.S we want to ensure that you are totally satisfied with your purchase. For this reason, we provide you with the following information to facilitate the returns process:
To make the return, the client must have clearly identified the reason why the return will be made, this in order to have controls and improve our services.
At the time of making the return, the information required to be effective must be provided. The data will be filled out in a PQR form.
Returned products must be in their original condition, without modifications or features foreign to the product.
To make the return, the purchase invoice must be attached.
The customer must express their claims at the time of making the return, this will be managed within a maximum period of 30 days counting from the moment the product is received.
Customers who wish to return a product must contact our salespeople and merchandisers, they can also make the return through the service channels +573156434807, to the email ventas.internet@avimex.co or through our social networks.
When the products arrive at the store, they are subjected to review, where it is verified that the information issued by the customer corresponds. This review is recorded in the reception and technical inspection format, in which the criteria established by the company are evaluated and the quality states are determined, whether the product is approved, quarantined or rejected.
The customer may request a refund of their money, exchange of the product for a new one, modifications or cancellations of the delivery note as the case may be.
WARRANTY POLICY
Our goal is your satisfaction and to ensure the quality of the products, therefore, we inform you about what you need to know to apply and request the guarantee process.
Moments when the guarantee applies at Avimex de Colombia S.A.S:
If you received a product with manufacturing defects or in poor condition.
If the product does not fulfill its purpose, functions incorrectly or is incomplete.
If the product presents damage due to transportation at the time of shipment.
If the product wears out prematurely under normal conditions of use.
If the benefits of the product are not in line with your expectations and you are dissatisfied with it.
The guarantee will not be recognized in the following cases:
If the product has been used incorrectly, abusively or negligently.
Unauthorized product modifications.
Not following the instructions for use of the product.
Normal product wear.
Joint use of chemical elements that deteriorate and affect the operation of the product.
Events that cannot be controlled by Avimex de Colombia S.A.S (Natural disasters, floods, cases of vandalism, damage by pests or rodents, etc.) As long as the product is already in the user's possession.
When the product has been manipulated (whether for manufacturing, accessories, etc.) by companies other than Avimex de Colombia S.A.S.
Generalities of the guarantees in Avimex de Colombia S.A.S:
Avimex de Colombia S.A.S ensures 100% of the guarantee.
Shipping and collection costs of products for guarantees are covered.
At Avimex de Colombia S.A.S we strive for the satisfaction of our clients, therefore, our actions will be focused on the benefit of our clients.
Avimex de Colombia S.A.S provides bonuses or discounts for clients in the case of guarantees, Avimex de Colombia S.A.S will have complete freedom to determine the value and whether or not the client applies to these benefits.
The client will have a maximum period of 6 months to apply and request the guarantee; The time will be counted from the date of delivery of the product.
The client must communicate clearly and respectfully the reason why they are presenting the non-conformity and requesting the guarantee.
The client must clearly define and communicate what his or her claims are at the time of making the warranty request.
Avimex de Colombia S.A.S reserves the right to update the terms and conditions of this policy.
Procedure for the guarantee process in Avimex de Colombia S.A.S:
You can request the guarantee through the service channels established by the company, these are:
Salespeople and merchants are the main filter of attention for returns and guarantees.
Online sales channels Social networks, be it Instagram, X, Facebook, website. By phone and WhatsApp +573156434807 email ventas.internet@avimex.co.
In person at our offices located on Carrera 80C N°32EE-28 Laureles neighborhood (Medellín-Colombia).
The client must submit complete and detailed information at the time of making the request, this will be required in the service channels.
The product subject to warranty must be delivered, attaching your purchase invoice or identification of the buyer.
Once the product is received, it will be sent to the quality area, in charge of receiving and inspecting the product. According to the analysis, the guarantee is managed internally.
Through the guarantee, the customer may request a refund, exchange of the product for a new one or replacement, modifications or cancellations of the delivery note as the case may be.
It is important to keep in mind that the estimated time for receipt and review of the guarantee is fifteen (15) business days from receipt of the complaint or claim.
