The aim of this newly published legislation is to
establish the regulations for distribution of these devices, and
this activity is of the greatest importance throughout the
integrated circuit of supply of medical devices. In this respect,
it is important to note that these regulations apply at every stage
of the medical devices distribution circuit.
Ministerial Order no 256/2016 was published in Diário
da República, the official Portuguese Gazette, on 28
September 2016. It establishes the principles and rules of good
practices to be observed in the distribution of medical devices by
companies that engage in the wholesale distribution of these
devices and are licensed for this purpose under Decree- Law no.
145/2009 of 17 June, as amended by Law no. 21/2014 of 16 April, and
by Law no. 51/2014 of 25 August.
The rules on the manufacture, distribution and sale of medical
devices were already addressed in Decree-Law no. 145/2009 of 17
June, amended by Law no. 21/2014 of 16 April and by Law no. 51/2014
of 25 August. However, article 37(3) of that Decree-Law provided
that the rules on good practices for wholesale distribution of
these devices would be established by ministerial order.
In this context, a ministerial order has now been published that
establishes a system of good practices for distribution of medical
devices. In fact, the nature and function of these devices makes
exhaustive regulations necessary, to guarantee not only their
quality, but also that they are traceable when introduced into the
Under the legislation referred to above, a "medical
device" is defined as "any instrument, appliance,
equipment, software, material or article used in isolation or in
combination, including the software intended by its manufacturer to
be used specifically for diagnostic or therapeutic purposes, which
is necessary for the correct functioning of the medical device,
whose principal intended effect on the human body is not achieved
by pharmacological, immunological or metabolic
The rules and principles applicable to the wholesale
distribution of medical devices are already established in EU
Directive no. 94/C63/03 on good distribution practices. However,
with the publication of this ministerial order, the rules to which
wholesale distribution of these devices are now subject are now
enshrined in national legislation, which makes the rules in
question easier to apply.
The aim of this newly published legislation is to establish the
regulations for distribution of these devices, and this activity is
of the greatest importance throughout the integrated circuit of
supply of medical devices. In this respect, it is important to note
that these regulations apply at every stage of the medical devices
distribution circuit. This ensures there can be no deterioration
during the distribution and sale process. It also guarantees that
all transactions are registered and, therefore, that all medical
devices placed on the market are traceable.
The rules and procedures on quality control, monitoring,
traceability, dispatch, storage, security and recall from the
market are set out in specific terms, and this demonstrates the
scope of operations involved in this area.
The rules on good distribution practices now published
fundamentally address the requirements that apply to distributors,
their staff, their premises and equipment, the organisational
procedures to be adopted, the documentation and registration
relating to their operation that must be kept permanently available
at their premises, complaints in respect of counterfeit devices,
receipt and dispatch of devices, storage, transport, returns, and
procedures for recalling devices from the market and for rejected
The ministerial order applies to the activity of wholesale
distribution of medical devices in Portugal, including cases in
which the distribution activity is carried on from another Member
State by companies that have premises in Portugal.
In order to comply with the newly published provisions, licensed
wholesale distributors must adopt the guiding principles and rules,
and each distributor's technical manager will be responsible
for implementing and monitoring their application. On this point,
it is important to note that these rules apply to all of the
Finally, as is the case with the award of licences to distribute
and sell these types of devices, the authority responsible for
supervision of the implementation and compliance with the good
practices now published is INFARMED – Autoridade Nacional do
Medicamento e Produtos de Saúde, I.P. (INFARMED is the
Portuguese authority for medicines and healthcare products).
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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