Definition:

A medical device mean any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings and animals for one or more of the specific medical purpose.

About NDA (National Drug Authority):

National Drug Authority (NDA) was established in 1993 by the National Drug Policy and Authority Statute which in 2000 became the National Drug Policy and Authority (NDP/A) Act, Cap. 206 of the Laws of Uganda (2000 Edition). The Act established a National Drug Authority to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory healthcare and safeguarding the appropriate use of drugs.(1)  The control of surgical instruments and appliances will be based on risk assessment and risk management such that the level of regulatory control applied to them is proportional to the degree of perceived risk associated with the surgical instrument and appliance. The requirements of the review process differ for each class, type and technology of the appliance.(1)

Introduction of USA:

The FDA's Center for Devices and Radiological Health (CDRH) oversees the regulation of companies involved in producing, packaging, labeling, and importing medical devices available for sale in the US. Furthermore, CDRH is tasked with regulating electronic products that emit radiation, including medical equipment like lasers and x-ray systems, as well as non-medical devices such as microwave ovens and color televisions.

CDRH role in Medical device:

CDRH places every kind of equipment into the proper class according to the regulatory control requirements (Class I: merely general controls; Class II: standards; and Class III: premarket approval).

OBJECTIVE:

The objective of this study is to conduct a comprehensive comparison of the regulatory requirements for medical device dossiers in Uganda and the United States Food and Drug Administration (USFDA).  This comparison will focus on regulatory framework, dossier requirement, market dynamics, technical documentation, and approval process.

DISCUSSION:

MEDICAL DEVICE DOSSIER IN UGANDA:

Overview:

Surgical instruments and appliances will undergo classification according to a risk assessment and management framework. Regulatory oversight will correspond to the perceived risk level of each device, ensuring a proportional approach. The review process varies depending on the class, type, and technological complexity of the appliance, tailored to meet specific requirements.(2)

Market cap of UGANDA

• Revenue in the medical devices market in Uganda is projected to reach US$118.90m in 2024.
• The market largest market is Cardiology Device with a project market volume of US$18.56m in 2024.
• Revenue is expected to show an annual growth rate (2024-2028) of 7.57%, resulting in a market volume of US$159.20m by 2028.
• In global comparison, most revenue will be generated in the United States US$182.0bn in 2024.

Device classification:

The classification of medical devices is essential to ensure their safety, efficacy, and quality. In Uganda, the National Drug Authority (NDA) is responsible for regulating medical devices. The risk-based classification system categorizes medical devices based on the potential risk they pose to patients and users. This document outlines the criteria and classes used in the classification of medical devices in Uganda.(1)(3)

Application processing required document:

• Accurately detail application letter (Hard copy & soft copy)
• Bank deposit slip (prove of payment)
• Sample of the product (if applicable)
• Documentation / Dossier
• Prior market history and approval

Product registration dossier required technical document:

1. provided in English,
2. in a permanent and prominent manner,
3. Legible and
4. in terms that are easily understood by the intended user.

Market cap in USA

The U.S. medical devices market is anticipated to grow from $192.78 billion in 2023 to $291.04 billion by 2030, at a CAGR of 6.1% during the forecast period. According to the U.S census bureau report, by 2060, the number of patient suffering from diabetes is projected to increase by 25.1% to 162 million.(8)

Device Classes and Regulatory Oversight:

1. Class I General Controls

With Exemptions

Without Exemptions

2.Class II General Controls and Special Controls

With Exemptions

Without Exemptions

3.Class III General Controls and Premarket Approval(9)

 510(k) Notification:

Any individual looking to market a Class I, II, or III device in the US, intended for human use, and not requiring a Premarket Approval application (PMA), must file a 510(k) with the FDA, unless the device falls under an exemption from 510(k) requirements as specified in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and complies with the limitations outlined in .9 of the relevant device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).(10) A 510(k) is a submission made to the FDA before marketing a device. It's meant to show that the device is similarly safe and effective, or substantially equivalent, to an already legally marketed device as per Section 513(i)(1)(A) of the FD&C Act.(10) The submitter must wait until they receive an order confirming that the device is substantially equivalent (SE) before proceeding with marketing. Upon receiving the SE determination, the device can then be marketed in the US. Typically, the SE determination is made within 90 days based on the information provided by the submitter.

510(k) Required when:

1. Any new device market in first time
2. Substantial change
3. Change in intended use
4. Different technological characteristic
5. Combination product

510 (k) Submission process:

Acknowledgement of receipt:

You can submit your 510(k) application by sending either an e-STAR or an e-Copy.(10) Once you submit your 510(k) application to the FDA, they assign it a unique control number upon receipt. This number, known as the "510(k) number" or "K number," starts with the letter "K" followed by six digits.(10) The last four digits represent the sequential submission number for that year, starting with 0001 and increasing with each succeeding submission, while the first two digits indicate the calendar year the submission was received.

“KXXZZZZ”

Where, K = 510(k)

XX = years of submission

ZZZZ = sequence number

For example: the first 510(k) submission for calendar year 2022 is “K220001”

510(k) Submission process flow chart:

The FDA's premarket approval (PMA) process involves a thorough scientific and regulatory review to assess the safety and efficacy of Class III medical devices. Class III devices are categorized as those crucial for supporting human life, significantly preventing health impairments, or posing a potential and unacceptable risk of illness or injury The regulation for premarket approval is found in Title 21 of the Code of Federal Regulations (CFR), Part 814, which covers Premarket Approval of Medical Devices.

When PMA is required:

Class III devices, which are classified under the strictest regulatory category for medical devices, are subject to PMA criteria. The Product Classification Database can be used to find product classifications for devices. The device name, classification, and, if available, a link to the pertinent section of the Code of Federal Regulations (CFR) are included in the database search results. The device type name, device ID, and categorization data are all listed in the CFR.

The CFR provides a regulatory number for Class III devices that were sold before the Medical Device Amendments of 1976.  Use the three-letter product code to check the Premarket Approval (PMA) and the 510(k) Premarket Notification databases if you're not sure if the unclassified device needs a PMA. Furthermore, a new type of device may not be found in the product classification database. If the device is a high risk device, (Supports or maintains human life, is critically important in preventing health impairments, or poses a significant and unreasonable risk of illness or injury) Before being commercialized in the United States, a device must receive an approved PMA if it is found to be not substantially equivalent (NSE) to a Class I, II, or III [Class III needing 510(k)] device. Nevertheless, some devices may be eligible for the De Novo process to be classed as a Class I or Class II device if it is determined that they are not substantially equivalent to a certified Class I, II, or III (not requiring PMA) device.

Labelling:

Define ‘labeling’ as a:

First of all, let’s establish what labeling is and what it isn’t. Labeling is written, printed, or graphic matter affixed to or associated with a medical device that is related to its identification, technical description, or use.

Documents

Example of US labelled:

UDI requirement:

COMPARISON: