Terms and conditions

GENERAL CONDITIONS OF SALES
THESE CONDITIONS APPLY TO ALL OUR OFFERS AND AGREEMENTS WITH THIRD PARTIES
1. Our prices are entirely without obligation until orders are accepted in writing. The undertakings entered into by our representatives are only valid following our written confirmation, subject to interim wage and or raw material price increases, as well as any revaluations of currencies domestically and abroad. If this and/or other pricedetermining factors change, we reserve the right to pass on any ensuing price differences in consultation with the customer.
 
2. The delivery date is not seen as an express commitment, since it is based on currently applicable materials supplies and production possibilities. Unless otherwise specified, late delivery through no fault of our own may not give rise to rejection, claims for compensation or cancellation.
 
3. Unless we expressly specify to the contrary, all our invoices must be paid at Bilzen no later than the due date without any reduction or discount. If an invoice is not paid in full by the specified date we shall be entitled, from the next day, by right and without notice of default being required, to payment of interest as laid down in Article 5 of the Act of 02/08/2002 without however the interest rate thus obtained being less than 12% per annum. By not making payment within by specified date our co-contractor also acknowledges having committed a breach of contract and consequently having caused us to suffer loss.
 
This loss, including the recovery costs referred to in Article 6 of the Act of 02/08/2002, must be compensated for by our co-contractor and is estimated as follows:
 
- to cover extra-juridical recovery costs and the extra administrative work compensation is estimated equal to 10 % of the outstanding balance with a minimum of €75,00, plus a one-off sum of €13,00 per reminder together with any registration fee; if we also call in third parties for the out-of-court recovery of the amounts claimed by us these costs will also be passed on to the co-contractor;
 
- if we are obliged to move to judicial recovery our co-contractor shall, insofar as he is bound by the personal scope of the Act of 02/08/2002, pay us all costs incurred by us as a result of judicial recovery without however this payment being less than the amount obtained in application of the rate of those sums that are recoverable costs by virtue of the execution of certain material deeds, as decreed by the King in execution of Article 1022 of the Judicial Code.
 
Any delay in payment for whatever reason shall also entitle us to sever the contract and demand immediate payment of all amount owed, even those not yet due. Are always settled first with the interest due by virtue of the present terms, then with compensation and recovery costs and only then with the outstanding balance of each invoice, whereby the oldest outstanding amounts are also settled first, regardless of any comments or notifications of the co-contractor on the occasion of his payments. In the event of late payment we reserve the right to declare any discounts granted null and void and demand repayment thereof, even with retroactive force. If a bill of exchange is accepted in payment this shall not in any way affect the current terms of payment. The goods delivered by us remain our property until our invoices have been paid, where applicable including the above-mentioned interest for late payment, loss provision and costs.
 
4. We guarantee the new equipment supplied by us for the duration of the warranty period, which starts on the shipping date of the item in question. This guarantee only applies to demonstrable material and construction faults. The guarantee provision does not apply to normal consumable items such as electrodes, electrical cables, mains leads, sponge –bags, compresses, ect. Complaints following material and construction faults can only dealt with if the goods and/or parts concerned are back in our possession. The guarantee only applies if the equipment is operated and used correctly, no change or repair has been made to them- except by our own personnel – and the damage is not the result of normal wear and tear, injudicious handling or other factors not at all our fault. We are free in our assessment in this respect. Damaged items are only taken back via the RAN procedure.
 
5. The counterparty agrees to maintain all information to enable GymnaUniphy NV to be aware of parts and serial numbers of equipment supplied, date of delivery and name and address of the customer and all the service activity in relation to that equipment.
 
Any incident with a product of GymnaUniphy NV should immediately be reported to GymnaUniphy’s with all the details of the incident. The counterparty may not use or sell any other accessories for GymnaUniphy products than those prescribed by GymnaUniphy, If other accessories are used, the CE certification of the products will no longer be valid.
 
6. GymnaUniphy NV reserves the right to charge administration and transportation costs, in case the order is less than €250.
 
7. All our catalogues, brochures, manuals, photos, texts, drawings, cost estimates, etc. shall remain our property. They may not therefor – except with our express approval be copied or shown to third parties. If we so request, these items must be returned to our address.
 
8. If an order is extended we shall consider the previous conditions to have been accepted by the client. Any objections or complaints must be made known to us in writing within 8 calendar days. Orders or other documents of clients are only binding following confirmation on our parts.
 
9. In the event of a dispute the Courts of Tongeren shall have sole jurisdiction. All disputes shall be governed by Belgian law.
 

Annex to Terms & Conditions:

Quality and Regulatory Requirements for Distributors of Medical Devices

Note 1:    referenced articles are from the regulation on medical devices EU/2017/745 available at http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745

Note 2:    EEA+CH refers to the member states of the European Union and European Economic Area plus Switzerland

Article 1 – General

The DISTRIBUTOR agrees to the terms of this Annex when the PRODUCTS are considered MEDICAL DEVICES under the present legislation.

Article 2 - Obligations of the LEGAL MANUFACTURER

The PRODUCTS will be delivered by the LEGAL MANUFACTURER with CE-marking, labeling and instructions for use (when applicable) in the language of the country of the DISTRIBUTOR, if available. Otherwise labeling and instructions for use will be provided in a language mutually agreed upon.

In case the PRODUCTS are commercialized outside the EEA+CH markets, the LEGAL MANUFACTURER will deliver, if available, any other required markings or certificates.

Where applicable, the LEGAL MANUFACTURER undertakes to create and maintain the technical documentation as required by local competent and/or regulatory authorities.

Where applicable, the LEGAL MANUFACTURER undertakes to register the products in local national databases as required by the legislation in the country of commercialization of the PRODUCTS.

When exporting outside the EEA+CH markets, the LEGAL MANUFACTURER undertakes on request to obtain a Free-Sales Certificate from the relevant competent and/or regulatory authorities.  This shall be provided to the DISTRIBUTOR.

The LEGAL MANUFACTURER shall provide training or training material to the DISTRIBUTOR as needed to properly conduct business activities. The DISTRIBUTOR is obliged to attend these trainings.

Article 3 – Obligations of IMPORTER

When the DISTRIBUTOR is also the IMPORTER, the provisions of this article are applicable.

In case the PRODUCTS are imported, information regarding the importer should be available either on the label, instructions for use or an additional document accompanying the PRODUCTS. This information should include the importer’s name, registered trade mark and the address of their registered place of business. (Article 11, 12/2)

The IMPORTER undertakes to comply with local legislation. In case the PRODUCTS are commercialized on the EEA+CH markets, the IMPORTER shall verify that

·         the PRODUCTS are CE marked

·         an authorized representative has been designated and

·         a Declaration of Conformity is made available.

·         Labeling is provided in compliance to local legislation

·         a UDI has been assigned to the PRODUCTS

·         the PRODUCTS are registered in the local electronic systems

For PRODUCTS commercialized outside of the EEA+CH markets, depending on local regulations, the importer shall verify that

·         the PRODUCTS are registered and market authorization/approval has been granted

·         a local legal representative has been designated and

·         MANUFACTURER, DISTRIBUTOR and LEGAL REPRESENTATIVE are registered

·         Labeling is provided in compliance to local legislation

·         a UDI has been assigned to the PRODUCTS

·         the PRODUCTS are registered in the local registration/licensing scheme

The IMPORTER shall place its name, registered trade name and registered place of business on the PRODUCT or its package or in an accompanying document.

The IMPORTER undertakes to keep a register of complaints, of non-conforming products and of product recalls and withdrawals. All relevant information shall be forwarded on request to the SUPPLIER and/or DISTRIBUTOR.

The IMPORTER shall, for the period of 10 years, maintain a copy of the EU Declaration of Conformity and, where applicable, a copy of all relevant certificates.

Article 4 – Regulatory Requirements

The DISTRIBUTOR undertakes to inquire and to keep the LEGAL MANUFACTURER informed about all various statutes and regulations which could be required by the LEGAL MANUFACTURER in launching, marketing and distributing the PRODUCTS in the CONTRACT AREA.

The DISTRIBUTOR undertakes to promptly inform the LEGAL MANUFACTURER of any changes which have occurred or could occur in the regulations applicable to the area covered by the present contract for the marketing and distribution of the PRODUCTS.

The DISTRIBUTOR undertakes to submit all information and documents necessary to obtain all possible locally requested declarations and approvals. When permitted by the local legislation, the original submission documentation shall be forwarded to the LEGAL MANUFACTURER.

The DISTRIBUTOR undertakes to support the transfer of all regulatory approvals and/or registrations to a designated local representative or license holder or back to the LEGAL MANUFACTURER on discontinuation of the contract, on requested of the LEGAL MANUFACTURER.

Article 5 – Registration to Local Competent Authorities

The DISTRIBUTOR undertakes to register its establishments if so requested to the local competent authorities. Proof of registration shall be forwarded to the LEGAL MANUFACTURER.

Article 6 - Audits

The DISTRIBUTOR undertakes to allow and support any planned and unannounced audits at its own expenses on request of the local competent authorities, notified bodies and other regulatory agencies.

The LEGAL MANUFACTURER also has the right to confirm the compliance of the DISTRIBUTOR to the requirements defined in this agreement by means of an audit.

Article 7 – Record keeping

The DISTRIBUTOR undertakes to keep appropriate records as evidence of compliance to the terms of this agreement.

The DISTRIBUTOR shall keep records to whom they have delivered the PRODUCTS.

The DISTRIBUTOR shall keep records on product repair and service activities and periodic safety inspections, corrective and preventive actions and vigilance cases.

The DISTRIBUTOR shall keep records of complaints, of non-conforming PRODUCTS and of PRODUCT recalls and withdrawals. (Article 12, 5)

On request, these records will be made available to the LEGAL MANUFACTURER. The DISTRIBUTOR will maintain all records for a period of 10 years.

Article 8 – Traceability

The DISTRIBUTOR shall maintain an appropriate level of traceability of devices with an adequate level of precision as agreed upon with the LEGAL MANUFACTURER.  

The upstream and downstream traceability of the PRODUCTS will be ensured such that, in the event an error is discovered, all other possible affected PRODUCTS can be identified immediately and restricted until corrective measures can be taken. Where applicable, the Unique Device Identification number will be used for tracking purposes. If not, a model name and serial or batch number will be used.

Where the local competent and/or regulatory require assignment and registration of UDI to the PRODUCTS, the LEGAL MANUFACTURER shall ensure UDI compliance is met. (Article 12/2) In this case, the DISTRIBUTOR shall keep track of the assigned UDI.

The DISTRIBUTOR commits itself, in order to ensure the best possible traceability of the PRODUCTS, to make out precise registrations stating the conditions in which the PRODUCTS have been distributed.  Such registrations must allow the identification of the following to the LEGAL MANUFACTURER and, if requested, to the competent authorities: (article 23)

·         Any economic operator to whom they have supplied the device

·         Any economic operator who has directly supplied them with a device

·         Any health institution or healthcare professional to whom they have directly supplied a device

These records should be maintained for at least 10 years after the last device covered by the declaration of conformity has been placed on the market. (Article 8)

Article 9 – Reporting

The DISTRIBUTOR undertakes to forward to the LEGAL MANUFACTURER any PRODUCT complaints and/or feedback, including local publications or press on the concerned PRODUCTS.

The DISTRIBUTOR undertakes to promptly inform the LEGAL MANUFACTURER of any possible malfunctions, deterioration in characteristics and/or possible misuse of products that has or could have led to the death and/or serious deterioration in the health of a patient or user.

The DISTRIBUTOR undertakes to communicate with the patient or the end user to gather information, investigate and/or resolve any issues.

On request of the competent and/or regulatory authorities, the DISTRIBUTOR undertakes to provide all the information and documentation at its disposal necessary to demonstrate compliance of the PRODUCTS to the local regulations. (Article 12/6)

Article 10 – Vigilance and Recall

In the event of a customer complaint, field safety corrective action (FSCA), an incident or near incident, the DISTRIBUTOR shall contact the LEGAL MANUFACTURER in writing without any delay that could be justified. The LEGAL MANUFACTURER will then initiate further action. The latest version of the MEDDEV 2.12-1 – Guidelines on a Medical Devices Vigilance System will be used as guidance. The latest version is available at:

http://ec.europa.eu/DocsRoom/documents/15506/attachments/1/translations/en/renditions/native

The DISTRIBUTOR shall keep records associated with complaints and (near) incidents.

When a PRODUCT that the DISTRIBUTOR has placed on the market is believed to be non-conformant with the local regulations, the DISTRIBUTOR shall immediately inform the LEGAL MANUFACTURER. (Article 12/3). The DISTRIBUTOR shall cooperate with the LEGAL MANUFACTURER and the competent or regulatory authorities to ensure that necessary corrective actions have been implemented. These may include, if appropriate, actions to bring the PRODUCT into conformity, withdrawal from the market or recall.

When the PRODUCT presents a serious risk, the DISTRIBUTOR undertakes to immediately inform the appropriate competent and/or regulatory authorities with sufficient details on the non-conformance and corrective actions taken. (Article 12/3). On request, the DISTRIBUTOR shall cooperate with the competent and/or regulatory authorities to eliminate the risks posed by the PRODUCTS. Also on request, the DISTRIBUTOR shall provide free samples of the PRODUCTS or, where impracticable, grant access to the PRODUCT. (Article 12/6)

In the event of not respecting the above paragraph, the DISTRIBUTOR is held responsible for any liability claim and associated cost. Furthermore, the contract will stop directly, immediately and without notice.

The LEGAL MANUFACTURE undertakes to inform the DISTRIBUTOR of any corrective actions taken in relation to the PRODUCT that might be needed to respond to safety issues or to bring the PRODUCT into conformity. The DISTRIBUTOR shall maintain adequate quality management system processes to make sure it obtains all such information. (Article 14/3)

For non-EEA+CH markets other regulations apply. For some of the key markets, applicable regulations can be found at:

USA:          https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

Brazil:        http://portal.anvisa.gov.br/

Canada:    http://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

Korea:       http://www.mfds.go.kr/

Taiwan:    https://adr.fda.gov.tw/

Australia: https://www.tga.gov.au/standards-guidelines-publications-medical-devices-ivds

China:       http://eng.sfda.gov.cn/WS03/CL0758/

Japan:       http://www.pmda.go.jp/safety/reports/hcp/pmd-act/0002.html

Article 11 – Clinical Evaluations and Clinical Trials

The DISTRIBUTOR shall not perform any post-market clinical evaluations or clinical trials without the prior written approval of the LEGAL MANUFACTURER.

Article 12 - PRODUCT Labeling

The DISTRIBUTOR will not change any labeling (defined as any written, printed or graphic information appearing either on the device itself or on the packaging of each unit or on the packaging of multiple devices and also includes the instructions for use which inform the user on the device’s intended purpose) provided with the PRODUCT, without the written consent of the LEGAL MANUFACTURER. Changes to labeling include alteration, removal, modifications and translations.

In case the information supplied with the PRODUCT needs to be translated according to the requirements of the Member State where it should be placed on the market, the DISTRIBUTOR shall obtain a written consent of the LEGAL MANUFACTURER to perform such an activity. The DISTRIBUTOR undertakes to have procedures in place that ensure that the translated information is accurate and up-to-date.  The translation of the information supplied with the PRODUCT shall be indicated by the DISTRIBUTOR on the package or, if impracticable, in an accompanying document, along with its name, registered trade name and address. (Article 14/2,3)

The DISTRIBUTOR undertakes to inform the LEGAL MANUFACTURER and the competent and/or regulatory authorities at least 28 days prior to making available on the market of the relabeled PRODUCT. The DISTRIBUTOR shall provide a sample of the relabeled PRODUCT to the LEGAL MANUFACTURER and, upon request, also to the competent and/or regulatory authorities. (Article 14/4)

The DISTRIBUTOR shall, within the same 28 calendar day period, obtain a notified body certificate for their quality management system and will forward this certificate both to the LEGAL MANUFACTURER and the competent and/or regulatory authorities. (Article 14/4)

Article 13 – PRODUCT use during exhibitions

The DISTRIBUTOR using the PRODUCT at trade fares, exhibitions or other similar events shall clearly mark that the PRODUCT is destined for this purpose and cannot be marketed until clearance from the competent authorities is obtained.

Article 14 – Promotional Material

All promotional material created by the DISTRIBUTOR, including but not limited to advertisements, claims or labels shall be reviewed upfront and approved by the LEGAL MANUFACTURER before commercialization of the PRODUCT.  

The DISTRIBUTOR undertakes to ensure that all promotional material complies with the local applicable laws and regulations.

The DISTRIBUTOR shall not promote in any way the off-label use of the PRODUCTS.

Article 15 – Repackaging

The DISTRIBUTOR will not change any packaging provided with the PRODUCT, without the written consent of the LEGAL MANUFACTURER. Changes to packaging include alteration, removal and modifications.

In case a change in packaging is desired, the DISTRIBUTOR shall obtain a written consent of the LEGAL MANUFACTURER to perform such an activity. The DISTRIBUTOR undertakes to have procedures in place that ensure that the repackaging will not affect the original condition of the device.  The repackaging of the PRODUCT shall be indicated by the DISTRIBUTOR on the package or, if impractical, in an accompanying document, along with its name, registered trade name and address. (Article 14/2,3)

The DISTRIBUTOR undertakes to inform the LEGAL MANUFACTURER and the competent and/or regulatory authorities at least 28 days prior to making available on the market of the repackaged PRODUCT. The DISTRIBUTOR shall provide a sample of the repackaged PRODUCT to the LEGAL MANUFACTURER and, upon request, also to the competent authorities. (Article 14/4)

The DISTRIBUTOR shall, within the same 28 calendar day period, obtain a notified body certificate for their quality management system and will forward this certificate both to the LEGAL MANUFACTURER and the competent and/or regulatory authorities. (Article 14/4)

Article 16 – Training

The LEGAL MANUFACTURER undertakes that sufficient training material is provided either in English or in a language mutually agreed upon with the DISTRIBUTOR.

The DISTRIBUTOR will make sure that its staff is adequately trained to safely handle the PRODUCTS.

The DISTRIBUTOR undertakes to provide sufficient training information to its customers for the handling and use of the PRODUCTS and provide adequate customer support and keep records of such training.

Article 17 – Installation, Maintenance and Service

The LEGAL MANUFACTURER undertakes to provide adequate documentation for training on installation and service. Where applicable, the LEGAL MANUFACTURER shall provide servicing activities in compliance with local regulatory requirements.

The DISTRIBUTOR undertakes to install and service the PRODUCTS according to the instructions and requirements defined by the LEGAL MANUFACTURER. All equipment used in servicing activities shall be according to international standards.

Article 18 – Storage and Transport

The DISTRIBUTOR shall store and transport (Article 12, 3) all PRODUCTS, as the specification of the PRODUCTs require. The PRODUCTS’ labeling shows the specifications needed for storage. The LEGAL MANUFACTURER will not accept liability due to improper storage and/or transport conditions.

Article 19 – Product disposal

The DISTRIBUTOR undertakes to properly dispose of returned products according to local regulations for electronic waste and medical equipment.

Article 20 – Legal representation

If so required by local regulations and when specifically designated by the manufacturer, the distributor shall take the role of local legal representative. Terminology for this local legal representative might be different depending on local regulations, e.g. Representative, Sponsor, Marketing Authorization Holder etc.

The local legal representative will, depending on local regulatory requirements, execute or support

·         Local PRODUCTS registration and/or market authorization/approval

·         Registration of manufacturer, distributor and legal representative

·         Communication with local regulatory agencies on significant changes

·         Registration of PRODUCTS in the local registration/licensing scheme

·         Translation of any communication to local regulatory agencies

·         Reporting and communication to local regulatory agencies for vigilance, Field safety corrective actions, advisory notices and/or recall cases

Article 21 – Cases of Counterfeit

The DISTRIBUTOR will inform the Manufacturer and its legal representative about the occurrence of cases of counterfeit, associated with MANUFACTURER’s products.