Accreditation
Procedure by which an authoritative body e.g. KMLTTB gives formal recognition that an organization e.g. medical laboratory is competent to carry out specific tasks against defined standards.
Clinical Evaluation
The assessment and analysis of clinical data pertaining to Medical laboratory Reagents and equipment in order to verify the clinical safety and performance of the Medical laboratory Reagents and Equipment.
Conformity Assessment
The systematic examination of evidence generated and procedures undertaken by the manufacturer, under requirements established by the KMLTTB, to determine that a medical laboratory reagent and equipment device is safe and performs as intended by the manufacturer.
Dossier
The documented evidence, normally an output of the quality management system, which demonstrates conformity of medical laboratory reagents and equipment to the Essential Principles of Safety and Performance of Medical Devices.
Medical Laboratory Reagents and Equipment
a reagent, an instrument, apparatus, or system, whether used alone or in combination, intended by the manufacturer (including laboratory developed tests) for in-vitro examination of a specimen derived from the human body solely or principally to provide information for diagnosis, screening, monitoring, predisposition, prognosis, prediction, or determination of physiological status.
Local Dealer (Local Distributors)
): any corporate body registered in Kenya that has received an authorization from the manufacturer with regard to matters pertaining to the sale and registration of the Medical laboratory Reagents and Equipment in Kenya. (the local distributors can be a distributor, importers, or suppliers).
Manufacturer
any person or company with responsibility to design and/or manufacture an Medical laboratory Reagents and equipment with the intention of making the Medical laboratory Reagents and equipment available for use, under his name; whether or not such an Medical laboratory Reagents and equipment is designed and/or manufactured by that person himself or on his behalf by another person(s).
Nonconformity
Non-fulfillment of a requirement.
Quality
Consistent and reliable performance of services or products conforming with specified standards.
Quality Management System (QMS)
Management system to direct and control an organization with regard to quality.
Post Market Surveillance (PMS)
the process of monitoring the safety of a device after it has been released to the market; it can further refine, confirm or deny, the safety of a device when it is used in the general population by large numbers of people.
Reciprocal Recognition (RR)
the process whereby an Medical laboratory Reagents and equipment diagnostic) already in use in the country, bearing the approval of an external Regulatory Authority, is recognized by KMLTTB upon meeting a given criteria
Validation
confirmation, through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled.
Verification
Comparison of performance characteristics with package insert or documented specifications.
Scope of the Medical Laboratory Reagent and Equipment Protocol
This section covers the evaluation and quality assurance activities required to ensure that premarket and post-market assessment activities of the Medical laboratory Reagents and Equipment are conducted to meet the needs of the users.
The protocol also provides conformity assessment and removes real and perceived barriers to marketing of Medical laboratory Reagents and equipment in Kenya. The audience for the protocol includes all manufacturers and local dealers who are marketing Medical laboratory Reagents and equipment as well as other professionals whose work relates to Medical laboratory Reagents and equipment use.
The protocol overall goal is to ensure public trust and confidence in medical laboratory diagnostics and in the administrative systems, by which they are regulated, based on the safety and performance of these products. Specifically, the protocol seek to:
a) establish minimum standards for quality of medical laboratory devices and diagnostics for use in Kenya;
b) Ensure quality and efficiency in the registration, validation and licensure of medical laboratory equipment and reagents.
POLICY STATEMENT
KMLTTB shall ensure compliance of Medical laboratory Reagents and equipment devices in accordance with MLTT Act, CAP 253A.
The protocol sets out the requirements relating to the safety and performance characteristics of reagents and equipments.
.
Essential Principles (EPs)
The essential principles set out the requirements relating to the safety and performance characteristics of Medical laboratory Reagents and Equipment. Compliance with relevant essential principles ensures that use of the reagents and equipment’s does not compromise the health or safety of patients, users or any other person, and that benefits arising from use of the reagents and equipment outweigh the risks. For Medical laboratory Reagents and equipment to be supplied in Kenya, it must be demonstrated that the relevant essentials principles have been met. It is a manufacturer's responsibility to demonstrate that their reagents and equipment complies with the relevant essentials principles. This information must be the local distributors and maintained by the manufacturer and must be made available to KMLTTB upon request
Reciprocal Recognition (RR)
Reciprocal Recognition (RR) shall be applicable to Medical laboratory Reagents and equipment already in use in the country and bear the approval of an external Regulatory Authority recognized by KMLTTB upon meeting a given criteria.
Through conformity assessment documentation, it is assumed that these Medical laboratory Reagents and equipment have a proven quality track record. Laboratories may continue using the Medical laboratory Reagents and equipment until the final verdict from the KMLTTB is issued.
Premarket Evaluation
This section applies to Medical laboratory Reagents and equipment that don’t meet or satisfy the criteria for reciprocal recognition.
Pre-Market Controls
The manufacturer shall provide technical documentation detailing conformity of the Medical laboratory Reagents and equipment to the essential principles (EPs) of safety and performance of Medical laboratory Reagents and equipment medical devices prior to placing the product on the Kenyan market.
The manufacturer needs to receive a notice of approval to market the Medical laboratory Reagents and equipment before it can be introduced into Kenyan market.
The complexity of the required technical documentation will vary according to the classification of the Medical laboratory Reagents and equipment.
Medical laboratory Reagents and equipment Classification
Medical laboratory Reagents and equipment devices are grouped into four classes based on the level of risk as shown in Table 1 below. The Medical laboratory Reagents and equipment manufacturer is required to demonstrate compliance with the classification principles based on:
• The manufacturer’s intended use of the device and
• The level of risk to the patient and the public.
Table 1: Classification System for the Medical laboratory Reagents and Equipment
Medical Laboratory Reagents and Equipment Classification
Medical laboratory reagents and equipment are classified into four classes based on risk. Manufacturers must demonstrate compliance based on the intended use and level of risk to the public and patients.
| CLASSIFICATION | LEVEL OF RISK | EXAMPLES |
|---|---|---|
| Class A | no public health risk or low personal risk | Clinical Chemistry Analyser, prepared selective culture media |
| Class B | low public health risk or moderate personal risk | Vitamin B12, Pregnancy self testing, Anti-Nuclear Antibody, Urine test strips |
| Class C | moderate public health risk or high personal risk | Blood glucose self testing, HLA typing, PSA screening, Rubella |
| Class D | high public health risk | Blood donor screening, HIV Blood Testing |
Coding System of Medical Laboratory Reagents and Equipment
KMLTTB shall adopt the Global Medical Device Nomenclature (GMDN) coding system used by international bodies to consistently describe the Medical laboratory Reagents and equipment.
The GMDN codes are used to assist in the:
- Consistent assessment of the Medical laboratory Reagents and equipment before they are released into the market.
- Continuous monitoring of Medical laboratory Reagents and equipment once they are available in the Kenyan market.
The code will be assigned by KMLTTB upon validation and approval of Medical laboratory Reagents and equipment.
Clinical Studies
The manufacturer shall notify KMLTTB prior to commencement of any clinical study to be undertaken in Kenya that involves Medical laboratory Reagents and equipment but has not received and/or is undergoing regulatory approval process.
Validation of Medical Laboratory Reagents and Equipment
Evidence to demonstrate the analytical performance characteristics of the Medical laboratory Reagents and Equipment is a requirement under Essential Principle and forms a critical part of the manufacturer’s performance evaluation studies, as required for clinical evidence.
KMLTTB shall contract Accredited Agencies (AAs) to carry out validation in accordance with the criteria set by KMLTTB (See Annex 2).
All AAs shall have a Validation Policy and Validation Master Plan (VMP) that detail the arrangements for undertaking validation and qualification.
The Manufacturer or local dealers (LOCAL DISTRIBUTORSs)/Vendors (on behalf of the manufacturer) shall submit a dossier of the Medical laboratory Reagents and Equipments prior to commencement of validation activities (See Annex 3 for the application form).
KMLTTB shall publish and make widely available a list of all approved medical laboratory reagents and equipments in Kenya for the information of end users and manufacturers. The list shall be periodically reviewed and updated.
When validation procedures are changed so that results or their interpretation may be significantly different, the implications shall be explained to KMLTTB, prior to the introduction of the change.
Post Market Surveillance and Responsibilities
Once Medical laboratory Reagents and Equipment has been introduced in the Kenyan market, the must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval.
The requirements facilitate the systematic investigation of failures and/or deviations in the way a device performs, in an attempt to prevent an adverse event occurring again.
Manufacturers, local dealers, local distributors/vendors, KMLTTB and users have responsibility for post-market monitoring of the approved Medical laboratory Reagents and Equipment.
- utilize the Medical laboratory Reagents and Equipment as specified by the manufacturer
- monitor and document routine performance and safety of the Medical laboratory Reagents and Equipment. Any non-conformance associated with the Medical laboratory Reagents and Equipment should local distributors be reported to KMLTTB.
- Establish and operate active surveillance programmes for approved Medical laboratory Reagents and equipment, have a mechanism for collecting Medical laboratory Reagents and equipment safety and performance data, and have a well-defined reporting system to track adverse events associated with the use of Medical laboratory Reagents and equipment in the country.
- investigate alleged breaches of the legislation; and initiate prosecutions where appropriate
- Disseminate information that local distributors be used to prevent or minimize the consequences of adverse events, where appropriate; - remove the device from the market
- actively monitor the performance of their products in the market
- ensure that necessary steps are taken to correct non-conformities
- The new product is validated and registered with KMLTTB within a time period 3 to 6 months after approval and before importation into the country.
- the Medical laboratory Reagents and Equipment is correctly classified
- The Medical laboratory Reagents and equipment is properly handled before it reaches the end user.
- Adverse events involving their Medical laboratory Reagents and Equipment are reported to KMLTTB within statutory timeframes that depend on the seriousness of the incident.
- An annual report including all complaints relating to problems with the use of the device is submitted to KMLTTB.
- Repackaging of the Medical laboratory Reagents and equipment,
- Removing or adding components to the test kit or;
- Altering the product labelling.
Users shall
KMLTB shall:
Manufacturers shall:
The local distributors shall ensure that:
The distribution records of the device are kept to:
-expedite any recalls of batches of the Medical laboratory Reagents and Equipments -identify the manufacturer of each batch of Medical laboratory Reagents and EquipmentsLocal Dealers shall not engage in adulteration of Medical laboratory Reagents and equipment; this includes, but is not limited to:
Fees and Charges:
All costs relating to registration of the Medical laboratory Reagents and Equipments shall be met by the manufacturer or a local distributors appointed by the manufacturer.
The schedule of fees and charges under the Medical laboratory Reagents and Equipments framework will be available on the KMLTTB website. The fees and charges will be reviewed on a regular basis and published on the KMLTTB website.
Non-payment of annual fees and charges for medical devices will result in the cancellation of the relevant products from the Board database. Once cancelled, a new approved application is required before supply of the device can resume.
Corrections and Recalls:
Once Medical laboratory Reagents and Equipment device is in the Kenyan market, the device must continue to meet all the regulatory, safety and performance requirements.
If there is a problem with a device or the way in which it is being used, the local distributors and manufacturer shall conduct an analysis and make a decision on the appropriate action.
Some actions that may need to be taken could local distributors include to:
- Follow corrective actions / preventive actions procedures under the manufacturer‘s quality management system
- Inform the users of the device .
- Make corrections to the device
- Recall or remove the device from the market
When the need for a recall of Medical laboratory Reagents and equipment device has been established, the local distributors or manufacturer of the affected device shall be responsible for the recovery of the devices.
Where recall is refused, or is not carried out satisfactorily, KMLTTB shall order a mandatory recall. Failure to comply with such an order shall result in substantial fines.
Flowchart of supplying Medical laboratory Reagents and equipment to Kenya
Criteria for Selection of Medical Laboratory
KMLTTB shall conduct an evaluation of each prospective validation medical laboratory prior to any engagement between the medical laboratory and KMLTTB.
Criteria for Selection of Validating Laboratories:
- The Medical laboratory must be licensed and/or accredited for the test under evaluation.
- Availability of suitably trained, adequate and competent personnel.
- The test under evaluation should be routinely performed at the evaluating medical laboratory.
- Adequate, relevant, and functional medical laboratory facilities for conducting the evaluation.
- Ability to obtain, prepare, and characterize specimens.
- Capacity to store specimens in appropriate conditions.
- Capacity and ability to ensure safety and security of specimens and Medical laboratory Reagents and equipment.
- The medical laboratory must have an established, and demonstrate compliance to, an accepted Quality Management System.
- Availability of appropriate Standard Operating Procedures (SOPs). Ability and willingness to comply with the given SOPs.
- Sufficient data-handling capacity (staff and computers) and able to perform data analysis (on-site, if possible).
Confidentiality Requirements:
The Medical laboratory management and personnel involved in verification/validation activities shall be independent of both the manufacturers and Local Dealers for Medical laboratory Reagents and equipment under study.
Following appointment, the validating laboratories will be monitored at intervals determined by KMLTTB. The board reserves the right to withdraw services of a validation agency if the agency fails to maintain and comply with set standards.
The Validation agencies shall have made adequate arrangements to ensure confidentiality of the information obtained in the course of carrying out a Verification/Validation study. This shall ensure no details, records, results, or any other information is disclosed to any party except KMLTTB and the manufacturer.
The validation agency must demonstrate impartiality in the assigned validation activities.