Risk Based Classification of Medical Devices and grouping
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The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
Risk Based Classification of Medical Devices and grouping
- 1. www.pharmacyboardkenya.org Pharmacy and Poisons Board REPUBLIC OF KENYA MINISTRY OF HEALTH PHARMACY AND POISONS BOARD RISK BASED CLASSIFICATION AND GROUPING OF MEDICAL DEVICES DR PAULYNE WAIRIMU 25th October 2018 Stakeholders sensitization PPB Boardroom, Lenana Road. 1
- 2. www.pharmacyboardkenya.org Pharmacy and Poisons Board 2 Introduction -Risk Based Classification of MD’s -STED -Grouping of MD’s -Overviews & Summary Medical Devices Roadmap
- 3. www.pharmacyboardkenya.org Pharmacy and Poisons Board Medical Devices Roadmap §2015-Setting up of the department under DPER §2016 Listing of Medical Devices with a view of knowing products in the market §2016-Import/Export control with requirements for permit for importation §2017-Establishment of Online Platform, creating a national Database of all Products coming into the country §2017-Enactment of the Health Act • Reference: AHWP-PLAY BOOK 3
- 4. www.pharmacyboardkenya.org Pharmacy and Poisons Board RBC AND GROUPING • Risk based classification of MD’s • For MD’s risk based on invasiveness to the body • For IVD’s, risk is based on degree of public health • Grouping is a system to help in the registration of similar product categories • Grouping of products in the same class. 4
- 5. www.pharmacyboardkenya.org Pharmacy and Poisons Board Risk Based Classification • Classification of Medical Devices to follow the A,B,C,D model. • Classification is based on the following factors ü Duration of contact with the body with the Medical Device ü The degree of Invasiveness ü medical device delivers medicinal products or energy to the patient ü intended to have a biological effect on the patient ü Local Versus Systemic Effect 5
- 6. www.pharmacyboardkenya.org Pharmacy and Poisons Board RISK BASED CLASSIFICATION OF IVD MEDICAL DEVICES 6 CLASS RISK LEVEL DEVICE EXAMPLES A Low Individual Risk and Low Public Health Risk Clinical Chemistry Analyser, prepared selective culture media B Moderate Individual Risk and/or Low Public Health Risk Vitamin B12, Pregnancy self-testing, Anti-Nuclear Antibody, Urine test strips C High Individual Risk and/or Moderate Public Health Risk Blood glucose self-testing, HLA typing, PSA screening, Rubella D High Individual Risk and High Public Health Risk HIV Blood donor screening, HIV Blood diagnostic
- 7. www.pharmacyboardkenya.org Pharmacy and Poisons Board STED • “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)”. 7
- 11. www.pharmacyboardkenya.org Pharmacy and Poisons Board Grouping Defined • For example, TRS MDB ORTHOPAEDIC SYSTEM consists of the following constituent- components (refer to Figure 1): • Instruments from ABC Bhd (a subsidiary of TRS MDB Kenya), • Instruments from XYZ Bhd (a subsidiary of TRS MDB Mexico), • Plates from TRS MDB Uganda; and • Screws from TRS MDB Zimbambwe • For the purpose of grouping, the manufacturer of TRS ORTHOPAEDIC SYSTEM will be TRS MDB KENYA (The Headquarters representing) 11
- 12. www.pharmacyboardkenya.org Pharmacy and Poisons Board Single Medical Device • A SINGLE medical device is a medical device from a manufacturer identified by a medical device proprietary name with a specific intended purpose. It is sold as a distinct packaged entity and it may be offered in a range of package sizes. • Examples • Condoms that are sold in packages of 3, 12 and 144 can be registered as a SINGLE medical device. • A company manufactures a software program that can be used with a number of CT scanners produced by other manufacturers. Although the software cannot function on its own, it can be used on different scanners. The software can be registered as a SINGLE medical device. • A company that assembles and registers a first aid kit has now decided to also supply each of the medical devices in the first aid kit individually. Each medical device supplied individually must be registered separately as a SINGLE medical device. 12
- 13. www.pharmacyboardkenya.org Pharmacy and Poisons Board Device family • A medical device FAMILY is a collection of medical devices and each medical device FAMILY member: • is from the same manufacturer; • is of the same risk classification; • has the same generic proprietary name; • has a common intended purpose; • has the same design and manufacturing process; and • has variations that are within the scope of the permissible variants. 13
- 14. www.pharmacyboardkenya.org Pharmacy and Poisons Board Device system • A medical device SYSTEM comprises of a number of constituent-components that are: – from the same manufacturer; – intended to be used in combination to complete a common intended purpose; – compatible when used as a SYSTEM; and – sold under a SYSTEM name or the labeling, instruction for use (IFU), brochures or catalogues for each constituent component states that the constituent component is intended for use with the SYSTEM 14
- 15. www.pharmacyboardkenya.org Pharmacy and Poisons Board Device System as a Family • In addition, if several SYSTEMs ful-fill the following conditions to be grouped as a FAMILY, they may be registered as a FAMILY: • the SYSTEMs are from the same manufacturer; • the SYSTEMs are of the same risk classification class; • the SYSTEMs have a common intended purpose; • the SYSTEMs have the same design and manufacturing process; and • key constituent-components of the SYSTEMs have variations that are within the scope of • the permissible variants. • has the same generic proprietary name 15
- 16. www.pharmacyboardkenya.org Pharmacy and Poisons Board Device System Example 16
- 17. www.pharmacyboardkenya.org Pharmacy and Poisons Board Dental Grouping Term • Similar to the system grouping • Dental material falling in the same categories 17
- 18. www.pharmacyboardkenya.org Pharmacy and Poisons Board Thank You! • Email: pwairimu@pharmacyboardkenya.org • Medicaldevices@pharmacyboardkenya.org 18