“CECMED Regulatory Overview: Medical Device Registration in Cuba”

Regulatory Authority

CECMED (Centro para el Control Estatal de Medicamentos, Equipos y DispositivosMédicos)

CECMED is a Regulatory Authority for Medicines, Equipment and Medical Devices of the Republic of Cuba. Responsible for promoting and protecting public health, through a regulatory system capable of guaranteeing timely access to the market of products with quality, safety, efficacy and truthful information for their rational use.

Overview of Regulatory Authority

The Centre for the State Control of Medicines and Medical Devices (CECMED) serves as the National Regulatory Authority appointed by the Cuban State to oversee the regulation, control, and supervision of products and services related to human health. Its primary mandate is to uphold health surveillance, safeguard the well-being of the population, and ensure the quality, safety, efficacy, and effectiveness of medicines and medical devices. 

Regulatory provisions for medical devices and in vitro diagnostic medical devices (IVDs) are delineated separately, with specific requirements outlined in resolutions, regulations, and instructions. These regulatory controls encompass all functions performed by the Cuban authority to ensure the effective oversight of these medical products. 

Dr. Mario César Muñiz Ferrer and Yadira Álvarez Rodríguez of CECMED provide a summary of these requirements, aligning with recommendations from international organizations and emphasizing compliance with essential safety, efficacy, and effectiveness standards.

Link for Regulatory Authority

https://www.cecmed.cu/

Local Regulation

Resolution No. 18/2000

CECMED Resolution No. 28/2023

https://www.cecmed.cu/reglamentacion/aprobadas

Classification of Medical Devices

Class I, IIa, IIb III and IV

Listing or Registration Requirements

• Once carried out the inscription in the Center, the procedure for the evaluation and registration of Medical Devices will consider the classification according to the risk level, (class I, IIa, IIb, III) that is established in the Regulation in its article 4.
• From the point of view of the regulatory requirements for the classification according to the level of risk, the regulations in Cuba adopted the system of rules of classification on the basis of risk of CE, (MEDDEV 10/93 revision 1996), and medical devices are classified into four classes (I, IIa, IIb, and III) in increasing order according to the level of risk, (Regulations, 1992).
• The classification of a given device is suggested by the manufacturer and CCEEM approves it.

Documents Required for Cuba Medical Device Registration

• Class I or IIa

1. Certification of the Sanitary Registration in the origin country.
2. Certification of an European Notified Body or of recognized Regulative Agencies
3. Presentation of the properly legalized representative’s power
4. Medical and Technical Specifications
5. Updated Quality System Certificate.
6. Manuals of Service, of users and of operations
7. Labels corresponding to the different forms of presentation of the device.
8. Written evidence of a Surveillance System for the Report of Adverse Events.

• Class IIb or III

1. Certification of the Sanitary Registration in the origin country.
2. Certification of a European Notified Body or of recognized Regulative Agencies
3. Presentation of the properly legalized representative’s power
4. Medical and Technical Specifications
5. Updated Quality System Certificate.
6. Manuals of Service, of users and of operations
7. Labels corresponding to the different forms of presentation of the device.
8. Written evidence of a Surveillance System for the Report of Adverse Events.
9. Result of the clinical assays or valid scientific evidence that demonstrate the
10. Effectiveness and safety of the device in medical practice.

Registration Timeline

• Obtaining a manufacturer’s license takes 1-2 months
• Obtaining a product license takes 8-12 months.

Registration Fee

• Manufacturer Inscription: 150,00 CUC; Renewable with a value of 50.00 CUC
• Application for Registration: It depends on the classification of risk and the complexity of the technology

License Validity

2 Years

License Renewal

45 days before expiry

• Application for Extension: It depends on the classification of the risk and the complexity
  of the technology, being the rates 50% of the value of the registration.

Special Labelling Requirements

In all the cases the documentation will be submitted in Spanish or English, except for User’s Manual and the labels that should be submitted in Spanish.

Who should make this Communication?

• Manufacturer
• Authorized Representative
  

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk