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HEALTH SECTOR
PREVIUOS OPERATING LICENSE TO FACILITIES
According to Royal Decree 192/2023, of the 21 of March, You will need a prior operating license. granted by the Spanish Agency for Drugs and Medical Devices:
a) Natural and legal persons engaged in the following activities:
- Mass manufacturing
- Manufacture of complete products to third parties
- Import, both legal and physical importers.
- Grouping
- Sterilization to third parties
- reprocessing
of medical devices, your accessories, devices and instruments used in permanent makeup, semi-permanent or on skin tattooing using invasive techniques, as well as non-medical devices listed in Annex XVI.
b) Natural and legal persons engaged in the following activities:
- Manufacturing
- Sterilization
- Grouping
- Import
for in vitro diagnostic medical devices.
c) Manufacturers of custom-made sanitary products in the autonomous cities of Ceuta and Melilla
d) Importers of custom sanitary products
To obtain it, companies must have:
- And Quality management system that guarantees the procedures and controls that ensure the quality of the products
- facilities and resources suitable for your activities
- Availability from a technical support with the right degree
- have a documentary file to store the generated documentation
- secure the compliance with requirements in the case of concerted activities
These licenses are valid for 5 years, so it is necessary to renew it before the Spanish Agency for Drugs and Medical Devices once the deadlines are met. This involves review of the quality management system, as well as the facilities, to ensure compliance with current regulations that apply.
Burotec can accompany you throughout the implementation process of the management system in accordance with the requirements of the Royal Decree 192/2023, on medical devices and Royal Decree 1662/2000, on in vitro diagnosis medical devices and on the necessary procedures before the Spanish Drugs Agency, until obtaining the relevant licenses.
DISTRIBUTION COMMUNICATION
Distributors and natural or legal persons engaged in the distribution activity must make a prior notification of the start of activity to the health authority of the autonomous community where the registered office of the company is, as well as the health authority of the community where the warehouse or warehouses are located, in the case in which they are not in the same community.
In order to carry out said communication, it will be necessary to implement some minimum quality procedures required that ensure complete control of the distributed products.
Our team of experts can help you throughout the processing process to carry out the distribution communication with your autonomous community, guiding them in the process until they can distribute their sanitary products.
MEDICAL DEVICES COMMUNICATION
One of the requirements demanded from the Spanish Drugs and Medical Devices Agency for all those class IIa devices, IIb and III that are marketed within the European community is the communication before the CCPS platform.
Our experts in medical device will be able to help you with all the management involved in this process., giving support throughout the registration process of your products.
TECHNICAL RESPONSIBLE
In order to obtain the prior operating license or the communication of distribution of sanitary products, companies have the obligation to have a responsible technician, with a university degree or a higher level training cycle that accredits an adequate qualification based on the products they are in charge of, who will exercise direct supervision of the products.
Within the responsibilities of the technician we find:
Directly supervise the activities of the company that fall under medical device regulations.
Verify that the products meet the requirements of the regulations that apply to them
Supervise the documentary file of the devices.
Market surveillance.
Review and evaluate incidents related to the products for the surveillance system and have the means to communicate them to the health authorities.
Being an interlocutor with the health authorities and collaborating with them in the execution of the measures that proceed, such as the withdrawal of the product from the market.
Provide health authorities, whenever it is required, the documentation that guarantees the conformity of the products with what is established in the legislation.
Preparation and supervision of marketing communications or commissioning of class IIa , and IIb devices.
Supervision of messages aimed at advertising and promoting devices.
Being an interlocutor with the health authorities and collaborating with them in the execution of the appropriate measures, such as the withdrawal of the device from the market
Thus, BUROTEC offers periodic technical assistance by one of our experts, with a university degree admitted by the Spanish Agency for Drugs and Medcial Devices to provide said service, or to train the Responsible Technician of your company.
RESPONSIBLE FOR COMPLIANCE WITH REGULATIONS
Manufacturers' organizations should have at least one person responsible for regulatory compliance who has the necessary experience in the field of medical devices.
From Burotec , we have experts in this field who can fulfill the regulatory compliance responsibilities that your company needs.
FDA REGISTRATION (ACCESS TO THE USA MARKET)
In USA there is a body called FDA (Food & Drug Administration) who is in charge of managing regulations and ensuring their application. Sanitary products are under the umbrella of said body, so they have to meet a series of requirements depending on their classification.
In a similar way to the European regulation, they are also classified according to the risk they may pose to users, establishing classes I, II and III, from lowest to highest risk.
From Burotec, We can help you throughout the process of creating and adapting your files and technical documentation in accordance with the regulations.FDA requirements. We accompany you in the different necessary procedures until obtaining the registration and placing your product on the market.
MARKED UKCA (UK MARKET ACCESS)
After the separation of the United Kingdom from Europe, New controls and requirements have been established that products must meet for their sale in the countries that comprise it.. Thus, is created the tagged UK Conformity Assessed (UKCA), certification that implies that the products comply with all the requirements of the regulations.
For all those economic agents who wish to place their sanitary products on the English market, they must, besides, to register in the MHRA and have a responsible person in the United Kingdom in the event that it belongs to a third country.
From Burotec we can help you prepare your technical documentation, as well as in all the necessary procedures to put your sanitary products on the English market.
CONSULTING ON REQUIREMENTS FOR COMPLIANCE WITH REGULATIONS
He continues it adaptation y publications of regulations applicable to medical devices implies, many times, changes to our documentation, technical files or procedures of our quality management system.
Our team of Burotec can advise you on any of these elements, being able to adapt to the needs of your company and solving the issues they have in order to stay in accordance with the current legislation.
TECHNICAL CONSULTANCY FOR COMPLIANCE WITH AEMPS
The Spanish Drugs and Medical Devices Agency (AEMPS) is the highest competent authority from the national territory in the field of medical devices and cosmetics. Thus, is in charge of compliance with the regulations of all economic agents in this sector as well as their products: files, Technical documentation, facilities o management systems are some of the examples.
Our experts They will be able to help you in any of the procedures that you need to carry out to be in accordance with the requirements of this organization..
ACCESS TO INTERNATIONAL MARKETS
The marketing of medical devices in third countries indicates compliance with the regulations of each of those countries.
Thus, each of them adheres to specific requirements and demands that their products must meet. From Burotec, We can advise you regarding applicable regulations and necessary processing in each of the countries, accompanying you in the process until the placing on the market of your medical device.