Welcome back to another week of MedTech Compliance Chronicles! As we begin the new year, we’re diving into one of the most critical aspects of entering the Colombian medical device market: preparing the required documentation for market authorization, which in Colombia is called a health or sanitary registration. Colombia’s regulatory framework, managed by INVIMA, ensures that medical devices and in vitro diagnostics (IVDs) meet stringent standards for safety, quality, and efficacy. Whether you’re registering a low-risk device or a high-risk diagnostic, understanding the documentation requirements is key to streamlining the process. In this post, we’ll outline the general requirements, as well as those specific to medical devices and IVDs, to help you navigate the regulatory landscape with confidence.
General Documentation Requirements
Before delving into the specifics for medical devices and IVDs, it’s essential to understand the foundational documentation that applies to all submissions. Administrative and legal documentation include proof of company registration (detailed in the sections below), an authorization letter appointing a local representative (a requirement for foreign manufacturers), and certificates of conformity with applicable legal standards. These documents ensure that the applicant has a legitimate presence in Colombia and meets baseline regulatory expectations.
Quality management system evidence is another critical requirement. Manufacturers must demonstrate compliance with internationally recognized standards, such as ISO 13485:2016, INVIMA’s GMP guidelines, or equivalent quality systems. While ISO 13485:2016 certification is not mandatory, it is widely accepted and can expedite the registration process. INVIMA’s GMP guidelines provide an alternative pathway, particularly for manufacturers without international certifications. If you are a foreign manufacturer, in addition to a GMP certificate for your facilities in your home country, you must ensure that your importer in Colombia maintains a Certificate of Capacity for Conditioning and/or Storage (CCAA), which is basically an abbreviated GMP for import and storage of medical devices. Note that if the importer performs any type of partial assembly of the device then they must also maintain a GMP certificate.
All documentation must be submitted in Spanish or accompanied by certified translations if originally prepared in another language. Accurate translations are crucial to ensuring the application meets INVIMA’s standards and avoiding delays during the evaluation process.
Specific Requirements for Medical Devices
For general medical devices, the documentation requirements vary based on the device’s classification, which is determined by the associated risk (Class I, IIa, IIb, III). Lower-risk devices require fewer details, focusing on basic product specifications, while higher-risk devices require extensive evidence to validate their safety and efficacy.
For all medical devices, you must submit a technical file. The technical file must include the basic product and manufacturer’s information, as well as the device’s risk classification, indications for use and contraindications, shelf life, warnings and precautions and the proposed labeling and inserts. Details of components / composition of the device and all verification and validation activities performed, and their results must be submitted. If applicable, you must submit information on the sterilization methods used and special disposal methods required. For class II (a and b) and III devices, you must also submit scientific evidence supporting the product’s safety. For class IIb and III devices you must also perform and submit the results of clinical studies proving the device’s safety and efficacy.
For class I and IIa devices, the process of obtaining a sanitary registration is called an automatic sanitary registration. Once you submit the general documentation and technical file, INVIMA will confirm its completeness and issue the registration within 2 days. For class IIb and III devices, INVIMA must finish its review of the technical file and approve the device.
In terms of documentation required for health registration of medical devices, Colombia makes a specific distinction not common on other markets. There is a special class of medical device called controlled biomedical technology. These are usually higher risk devices requiring specialized installation and maintenance. For these types of devices, the manufacturer must also commit to being able to supply replacement parts and maintenance services for up to 5 years from the date of sale, as well as provide training on how to use the device properly to the operators at the customer's location
Specific Requirements for In Vitro Diagnostics (IVDs)
For IVDs, the required documentation is also governed by risk classification, which aligns with the potential impact of an incorrect diagnostic result on public health. IVDs are categorized into low, moderate, and high-risk classes, with corresponding increases in the rigor of documentation requirements.
For classes I and II IVDs, the process of obtaining a health registration goes through what is called automatic health registration. Up to 15 IVDs of the same class or similar type / function can be on the same registration. In order to obtain an automatic health registration, you must fill out the application form from INVIMA and submit to them information on; the principle of the test, the quality specifications of the finished product, the classification and the content of the applied labeling. INVIMA will then verify that the application is complete and as soon as they do that you may begin marketing your device.
For class III (high risk) IVDs, a formal technical review of the device must be completed prior to receiving authorization. The technical evaluation will cover everything from the capacity of the manufacturer, the manufacturing processes, the safety and efficacy and even the relative effectiveness of the device compared to other devices marketed for the same intended use(s). In addition to the information required for class I and II IVDs, for class III IVDs you must include detailed information of the exact procedure, including all required tools, specifying tools or equipment needed but not included with the product. Details on the manufacturing processes and preparation, storage and stability of the reagent and all internal quality control procedures are also required. You must also provide the means of and explanations for any calculations the device performs, as well as information on the repeatability and reproducibility of the test. For class III you must wait until INVIMA finishes their technical review and approves the device before you can market it.
Conclusion
Preparing for market authorization in Colombia requires a thorough understanding of both general and device-specific documentation requirements. General requirements, including administrative, quality management, and language standards, form the backbone of all submissions. Specific requirements for medical devices and IVDs reflect their unique classification and risk profiles, with higher-risk products subjected to increased regulatory scrutiny to ensure public safety. By aligning your documentation with INVIMA’s standards, ensuring proper translations, and working closely with an experienced local representative, you can navigate the process efficiently and secure market access. Stay tuned for more insights as we continue exploring global compliance strategies!
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