Requirements for the Sanitary Registration of Medical Devices in Nicaragua

Requirements for the Sanitary Registration of Medical Devices in Nicaragua

02/06/2019

Bendaña & Bendaña / Nicaragua

All of the Requirements for the Sanitary Registration of Medical Devices in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75.

CLASS I. LOW RISK:

Sanitary license of the establishment, issued by the Directorate of Registration of Medical Devices of the Ministry of Health.
Free sale certificate that demonstrates its use in the country of origin.
Certificate of Good Manufacturing Practices (GMP).
Labels and packaging.
Medical devices must comply with one of the international certificates (FDA, CE, TUV) or its fully demonstrable equivalent among others.
The devices must comply with international standards of quality management applicability and current designation (ISO).
Power of legal representation from the manufacturer to the establishment for Registration purposes.
Power of the legal representative.
Responsible Healthcare Professional.
Technical and medical specifications, if applicable

For refurbished products, the declaration issued by the establishment that rebuilt it will be requested to guarantee its quality, safety and efficiency, in addition to the necessary spare parts for its maintenance.

CLASS II. MODERATE RISK:

Attach necessary scientific information that supports the safety of the product and an analysis of the risk of the medical device according to the indications, list of specific norms to be applied totally and partially, if applicable, and a description of solutions adopted to comply with the essential requirements of safety and operation, sterilization method if applicable.

Sanitary license of the establishment, issued by the Directorate of Registration of Medical Devices of the Ministry of Health.
Free sale certificate that demonstrates its use in the country of origin.
Certificate of Good Manufacturing Practices (GMP)
Sanitary registry of the country of origin.
Labels and packaging.
Medical devices must comply with one of the international certificates (FDA, CE, TUV) or its fully demonstrable equivalent among others.
The devices must comply with international standards of quality management applicability and current designation (ISO).
According to the type of the medical device, it must comply with one of the international safety standards for patients and operators with current designation according to regulations (UL, IEC, CSA) or its fully demonstrable equivalent.
Power of the legal representative.
Responsible Healthcare Professional
Technical and Medical specifications if applicable (In Spanish language).
Power of legal representation of the manufacturer to the establishment for purposes of Registration.
Standards of accuracy, precision and technical specifications in correlation for In-Vitro tests.
Samples in case of In-Vitro tests and periodic replacement material.
Catalog book updated where the product is shown.
Monitoring program provided by the manufacturer of medical devices for high-tech equipment.
Prior declaration of sterilization method (if reusable) for Medical Devices, if applicable.

For refurbished products, the declaration issued by the establishment that rebuilt it will be requested to guarantee its quality, safety and efficiency, in addition to the spare parts necessary for its maintenance.

CLASS III. HIGH RISK:

I – Clinical studies of third level on the use to demonstrate the safety and effectiveness.

II – In addition to what is established in the Class II requirements, submit the originals of the following information:

Description of the Medical Device, classification and the materials used in its manufacture (applicable to the level of risk).
List of countries where the Medical Device has been sold and a summary of any problems reported after entering the market, if any in those countries (applicable to the level of risk).
Medical device for In-Vitro diagnosis should be demonstrated that the experimental tests were performed in population and environments similar to those of the people to whom they are directed.
Clinical trials In-Vitro or in vivo for Medical Device Class III and IV, with the exception of Medical Devices from Australia, Canada, United States, European Union and Japan.
Presentation of a program to report therapeutic failures and adverse incidents for Medical Devices issued by the manufacturer. They should carry clinical studies of phase II and III, on the use to demonstrate safety and effectiveness.

CLASS IV. VERY HIGH RISK:

Clinical studies of phase III, on the use to demonstrate the safety and effectiveness.

In addition to what is established in the requirements of Class II and III, filing of originals of the following information:

Analysis and evaluation of risks and the measures to be adopted to reduce them, which satisfy the safety and efficacy requirements, prepared by the manufacturer.
Bibliography of published reports related to the use, safety and efficacy of the Medical Device.
In the case of the Medical Device for In-Vitro Diagnostics that use or have been manufactured from tissues or their derivatives of humans or animals, file objective evidence of the biological safety of these.

Requirements for Laboratory Reagent Supplies:

In addition to the established in the previous requirements, the literature of the input that should contain:

Biochemical principle of the test.
Presentation of the reagent.
Catalog number.
Lot Number
Description of the technique and the reagents used.
Due date of the product (for all DM sterilization quality or shelf life)
Test for which it is used.
Methods and procedures of the test
Storage conditions
Conditions for handling (Biosecurity Technical Sheet) when applying to the medical device
Symbology of the type of risk (Explosive, very toxic, corrosive, highly flammable, etc).
Method of disposal or final disposal of the product (when applicable).

Requirements for medical devices (Biomedical Equipment) used or refurbished:

In addition to what is established in the above requirements, a certificate issued by an internationally accredited entity that guarantees that the Medical Device complies with the requirements of safety, quality and efficacy.
The importation, acquisition or donation of used biomedical equipment of class I and II, which are considered as general and special control technology respectively, is authorized. For these devices, prior to their importation, they must be certified by the manufacturer or their representative in the country of origin or importer, stating that the equipment is not more than five years old and that it is in an optimum state of operation and functioning.
It is allowed to enter the country biomedical equipment replenished class III and IV provided they are accompanied by the certification of proper operation issued by the manufacturer or its legal representative in the country, in the same way as stated in the previous paragraph. If refurbished, in any way may alter the initial design of the equipment and the manufacturer or its official representative or the refactor authorized by the manufacturer shall ensure that the biomedical equipment has the same characteristics and effectiveness when the equipment was new.
The Ministry of Health is authorized to review at any time the records of Medical Devices issued, in order to verify whether they have modified the specifications thereof to the technical or scientific advances, so they may request validity documentation of the sanitary registration of a corresponding medical device.