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 supply chain.
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 means".
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...