The English Agency for Medicines and Medical Devices (Competent Authority) has issued instructions for prior authorization of medical facilities in order to obtain the license / registration to import, manufacture, assemble or sterilize medical devices.
Instructions PS 1 / 2011 for the processing of licenses for operation of medical facilities provided clarification on the procedure for obtaining prior permission from entities and facilities provided by Royal Decrees medical devices.
These instructions are particularly useful with regard to the qualifications and training of the person appointed as Technical Manager or Technical Guarantor, providing for the possibility of accepting as a professional technical manager not entitled to have at least 3 years experience in the manufacture of a sanitatios measure.
The rest of the instructions refer to the applicable regulations in this area, especially the Royal Decree 1591/2001, of medical devices.
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