An operating license emitted by AEMPS is required to perform Manufacturing activities; importation, medical kits manufacture and sterilization of medical devices; contact lenses without corrective purpose; products for tattooing; micropigmentation or permanent makeup by invasive techniques.
In the case of customized manufacture and distribution, it corresponds to the Autonomous Communities.
To obtain the license, companies must have:
− A Technical Manager certified to a suitable University-level health science qualification (Person responsible for regulatory compliance).
− Adequate facilities, means, procedures and personnel.
MEDICAL: OUR SERVICES
• Previous operating license, grouping or medical device manufacturing:
Advice, document preparation and management of the submission to approval by AEMPS (Spanish Agency of Medicines and Medical Devices)
• Revalidation and License modification:
Certain modifications after obtaining the license must be reviewed and communicated to the authorities and depending on the type will require approval.
• Responsible Person services or medical device Regulatory affairs:
We have experienced technicians that permit the fulfillment of the current legislation requirements by acting as the Person responsible for regulatory compliance to allow the obtention of the relevant license, as well as the distribution of medical devices. Whose involvement will depend on the activity that needs to be approved by the authorities.
• Advise in medical devices import:
Before proceeding with the purchase and import of medical devices, it is important to check compliance with current legislation in order to avoid problems with customs clearance.
• Outsourcing of warehouses approved by AEMPS:
– We advise you on the contracting procedure of outsourced warehouses for your import and distribution operations.
– Contract review & harmonization of protocols.
• Medical device distribution:
Medical device distribution must be communicated to the Autonomous Community and we offer consultancy in this field.
• Medical device marketing communication (MDMC)
Class IIa, IIb and III medical device marketing must be communicated to the AEMPS.
• Communication of European approved representatives to the AEMPS (European Representative EU REP)
Those manufacturers established outside the EU must have an authorized representative as an intermediary before the authorities. We can offer you such services.
• Marketing responsible registration:
Any manufacturer established in Spain placing on the market class I products, as well as customized products, or performing grouping and/or sterilization activities, has to communicate this activity to AEMPS in order to be included in the ´Registro de Responsables de puesta en el Mercado´. This obligation shall be extended to the authorized representative when it is established in Spain.
• Labeling and manuals review:
Labels, manuals and operating instructions and/or maintenance, must be reviewed and in accordance with current regulations.
• Supplier qualification:
As a previous step to the purchase of a medical device from a non-EU supplier, the supplier must be assessed and verified for their suitability for the product according to the current regulations.
• Communication of medical device distribution activity in the different Autonomous Communities:
Medical device distribution companies must inform the health authorities of the Autonomous Community about the start of the activity.
• Registration of products in the Andalusian health service (SIGLO):
Products intended for the Andalusian Health Service, must be registered in the SIGLO application (Sistema integrado de gestion logistica).
• Certificate of free sale issued by the AEMPS:
We carry out the procedures to obtain this certificate that will permit you to demonstrate the compliance of a product with current regulations.
• National Code of Parapharmacy
We process the Parapharmacy National Code, issued by the Consejo General de colegios de farmacéuticos (CGCF), necessary for the distribution of medical devices through the pharmaceutical channel (pharmacies and wholesalers).