Sanitary registration of medical devices in Peru

They play a crucial role in the field of health, as they contribute significantly to the diagnosis, treatment and prevention of diseases. In Peru, talking about the importance of the sanitary registration of medical devices is, perhaps, one of the most recurrent topics within the commerce industry due to its delicate work in the attention and care of public health. What organism is in charge of regulating them and how is their design developed nowadays? Find out now from SCR Consultores.

Sanitary registration of medical devices in Peru

According to the Sanitary Registration of Medical Devices (RSDM), the DIGEMID is the agency in charge of this requirement for commercial companies seeking to export their products or import them into the country. Medical devices are understood as those instruments, equipment, apparatus, materials or other articles used individually or in combination for diagnosis, prevention, monitoring, treatment or alleviation of diseases. These may range from simple instruments to more complex equipment.

Authorization request

Also known as the «Exceptional Import Authorization», it is a permit that can be accessed by all natural persons engaged in the trade of pharmaceuticals, sanitary and of course, medical devices. It is typified in Article 20 of Law No. 016-2011-SA, which focuses on prevention and its treatments. Regarding the procedure to acquire the sanitary registration of medical devices, the DIGEMID explained on its web platforms that it is a requirement to attach the patient’s medical prescription for personal use. Once this doubt is solved, it is necessary to fill out Annex 1 or «affidavit format» present in its web page. Then, attach the products with their characteristics. And finally, deliver them to the parts desk of the institution.

Types of medical devices

Medical devices range from simple utensils such as tongue depressors to more complex items such as heart-lung machines and pacemakers. However, within these categories we find very marked types that, according to Article 4 of Supreme Decree 016-2011-SA/MINSA «Regulations for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Medical Devices», are classified by their risk levels: Low (Class I), Moderate (Class II), High (Class III) and critical (Class IV).

A series of factors influence these categories, such as the useful life span, how much they will be used in the work environment, whether they are devices that mix functions to give a higher performance than originally expected or whether, on the contrary, they will do anything but what the manufacturer expected from the beginning. This and more emerges as the evident concern of the Government to control and monitor a health sector that, although it is hard to admit, has been undervalued over the years. This fact was reflected by the medical «inaction» before the arrival of Covid-19.

Devices that do not require sanitation records

As we said recently, there are some medical devices that do not require sanitation registrations to immediately access the market. However, this list is provided directly by the Ministry of Health (MINSA) through the General Directorate of Medicines, Supplies and Drugs (DIGEMID). This agency is authorized to grant commercial credentials to producers after the control and study of their components on an individual basis (i.e., input by input).  

For the DIGEMID, there is currently an Official List of 1,094 products that due to their nature, characteristics, performance and use are not considered registrable according to current sanitary regulations. In the official document published in January 2021, some important ones are detailed such as: 

• Hospital furniture.
• Reusable gowns for patients.
• Chemical products and reagents.
• Dental supplies and dental laboratory equipment.
• Biomedical equipment and clinical laboratory supplies,
• And others. 

It should be noted that as a company you must always take into account this list and its subsequent updates, otherwise you could fail to register a product that requires it and subsequently incur a serious offense for «threatening» public health. Penalties range from warnings, economic fines and in the worst case, the temporary or permanent closure of its facilities. Even a bad registration can provoke it.

How to register my devices in Peru?

To register your medical devices in Peru, the first thing you must do is to identify which ones are subject to go through this process. But first, a series of attributes established in Article 8 of the regulation must be fulfilled in order to achieve its commercial purpose. Some of them are:

• Be manufactured and designed in such a way that they do not compromise both customer expectations and the clinical condition of patients.
• To have patterns well below the average risk in their manufacture.
• They do not present difficulties in use for customers.
• A good management of their useful life, so their characteristics must be very punctual in order not to compromise their work.
• Be packaged in such a way that their functions are not affected by their transportation or storage.
• If it has defects, then its benefits will be greater.

Despite this, the procedure turns out to be a rather complicated stage for many companies, as it usually involves technical terms and additional investments in both time and money. Details that in one way or another end up delaying the production of the industry and therefore directly threatening the monetary interests of the corporation.Fortunately, SCR Consultores has for you the best solutions in consulting and regulatory representation for regulatory compliance, safety and quality management of your products. 

SCR Consultants at your service 

With almost 10 years of uninterrupted work in Peru, we have the best experienced specialists in regulatory project management. Don’t worry about the registration of your devices, our training and advice will be vital for you to manage your own procedures in record time. Request more information about medical devices by Clicking Here or by calling (511) 711-9070.  We are located at Rio de la Plata Street N ° 305 – 315, San Isidro. Lima – Peru. SCR Consultores, guiding the path of the national industry.