In January 2025, the Nicaraguan Mandatory Technical Standard (NTON 24001) came into effect, outlining the requirements and procedures for the sanitary registration of human-use medical devices in Nicaragua.
The standard establishes that the National Health Regulatory Authority (ANRS) will determine the classification of medical devices according to their risk level, regardless of their classification in other countries. Additionally, when a specific classification is required, the registrant must submit a request in accordance with Annex D of the standard, accompanied by a payment receipt, an official form, and the product’s technical data sheet in Spanish.
For combined-use medical devices, regulation will depend on their primary function. If the device exerts a predominant pharmacological action, it will be evaluated under Law 292, “Pharmaceutical and Pharmacy Law.” However, if its primary function is that of a medical device, with the pharmacological component being secondary, it will be governed by NTON 24001, with the quality and safety of the pharmaceutical component being verified by the ANRS Quality Control Laboratory.
Requirements for sanitary registration application
To obtain the sanitary registration of a medical device in Nicaragua, applicants must meet the following requirements:
- Approval issued by the ANRS Legal Advisory Section for the powers granted by the foreign manufacturer.
- Submit a valid Certificate of Free Sale (CLV) issued by the competent authority of the manufacturing country. If the expiration date is not specified, the certificate will be considered valid for two years from its issuance.
- ISO 13485 Certificate.
- CE Certificate.
- If the device is contract-manufactured, a copy of the approval issued by the ANRS Legal Advisory Section (SAJ) must be presented.
- Product monograph.
- Original labels and packaging or drafts of labels and packaging, in accordance with the application format and CLV.
- A sample of the product to be registered with a minimum expiration date equivalent to 80% of its shelf life.
Additionally, the Medical Devices Directorate will periodically publish a list of products that will undergo quality control analysis, along with the required sample quantities.
Sanitary registration application process
The sanitary registration process begins with the submission of the application in the Karplus system. If the application is rejected during the pre-evaluation, the registrant will have 15 business days to correct the observations. If the corrections are not made within the stipulated time or if non-conformities persist, the application will be canceled, and a new submission will need to be made with a new payment.
Once the file is accepted, it may be rejected twice during the technical evaluation, with a 20-day period granted to make corrections for each rejection. If non-conformities persist after the second correction, the application will be canceled, and a new submission will need to be initiated.
When a new device requires quality control analysis, the registrant must inform the Medical Devices Directorate of the product’s arrival and request an analysis from the Quality Control Laboratory Directorate, covering the corresponding fee.
If the analysis results in a “Non-Conforming” status, the applicant will have a maximum of 90 days to import a new batch and submit it for analysis, after paying the corresponding fee.
Once the sanitary registration application process is successfully completed, it will be valid for 5 years from its issuance.
Renewal and post-registration changes
Medical device sanitary registrations must be renewed between 9 and 6 months before expiration, maintaining the same registration number. If the application is not submitted within this period, the registration will be canceled once its expiration date is reached.
Regarding post-registration modifications, the standard stipulates that, in addition to the specific documents required based on the type of change, the Medical Devices Directorate may request additional information to support the modification. Changes that require a new sanitary registration include:
- Change of manufacturer.
- Change of contract manufacturer.
- Change of device brand.
- Change of trade name.
- Change in the material used in the device’s manufacturing.
lia.incer@garciabodan.com
Senior Associate
García & Bodán
Nicaragua