On September 28 Decree No. 256/2016 was published, establishing the Principles and Standards for Medical Devices Distribution Good Practice. The regime was developed, on the basis of EEC Directives 94 / C63 / 06, the essential components to be perceived by the manufacturer throughout the distribution process, with special focus on the requirements, procedures, expeditions and complaints. These principles and standards apply to all wholesale distribution activity in Portugal, even when this activity is developed from another Member State by entities that do not have facilities in Portugal.
The developed standards are primarily meant to act on the preservation measures of the quality and safety of medical devices traded in Portugal.
Decree No. 256/2016 lays down the essential requirements that must be followed by the manufacturer throughout the distribution process. Regarding the whole distribution process, the law delivers the following steps:
Entities engaged in such activity must respect the legal minimum in terms of personnel, equipment and facilities, being able to ensure proper storage and conservation (under the Decree no. 145/2009 of June 17). The aim is also to guarantee traceability of devices in the distribution chain.
A technical manager is required. He/she must be capable of ensuring compliance with the rules laid down by this law and ought to carry out his/her work personally and in person, except when there is an official delegation. It is also pointed out the need for proper training by all the personnel involved in the distribution process.
3. Facilities and equipment
Besides the hygiene conditions, it is so presented the procedures to be perceived regarding the storage of medical devices, taking into account the need for preservation and protection (warning of the danger of contamination).
The technical manager will be responsible for the approval and implementation of an organisational structure, in written form, covering all the responsibilities of each employee, regarding procedures related to all transactions incorporated in the distribution activity. This organisational structure shall provide for rules related to: hygiene maintenance; staff training; storage; remittances; transport monitoring; records; complaints handling; incident reports; internal audit; traceability, control and segregation of medical devices for export to third countries and monitoring after placing on the market.
5. Documentation and registration
All documentation and records related to the distribution activity must be properly kept and filled. In case contracted or subcontracted activities takes place, a contract in the written form is required, stipulating and outlining the responsibilities of both parties involved, under the condition that the contractor or subcontractor should undertake the full respect and implementation of the Good Distribution Practice.
In order to ensure traceability, all transactions made from the warehouse must be properly and fully recorded (setting forth the date, device brand/model, reference, lot code, price, address and contact supplier or recipient).
6. Complaints and fake devices
A computerised system for recording and handling complaints must be ensured. The distributor shall notify INFARMED whenever it suspects that a device is fake or is suspicions about the lack of compliance with the legally established requirements (Decree no. 145/2009 of June 17).
7. Reception and shipping
All shipments must be properly examined and double checked (regulatory compliance should be as EC Declaration of Conformity, CE Certificate, labelling and instructions for use under Decree no. 145/2009 of June 17 ). It also alerted to the special storage rules for devices subject to specific measures.
Quality conservation, security and performance of medical devices (temperature, humidity, pressure, light or radiation) rules are established. Also warns the need to create a rotation system ("first expired, first out"), subject to periodic checks. It is forbidden the sale of devices with an expired term validity.
Here are outlined the established requirements throughout the devices circuit transportation (maintenance of the identification, no contamination, protection against physical impact, temperature control and other natural conditions). The transportation responsibility is always the distributors’, regardless of contracting or subcontracting this transport.
The conditions and limitations in what regards to return operations (intact packaging, shelf life, prior assessment) are here established. The reinstatement decision is the technical manager’s responsibility. Non-reintegrated devices are categorized as rejected.
11. Market Collection
There must be an emergency plan collection (coordinated, maintained and run by the technical manager). All requests for collection must be properly recorded and INFARMED must be informed. The collection of devices involves classification as unmarketable.
12. Rejected Products
The destruction of rejected devices can be contracted or subcontracted to entities duly authorized for the purpose, being required a written form contract between the parties.