Medical Device Regulatory Framework

Transcription

1 Medical Device Regulatory Framework 24 July 2015 SAMED Member Meeting

2 Contents 1. Context 2. Regulatory framework Key concepts Process 3. Changes 4. What to do?

3 1. Context Act 101 of 1965 as amended Draft medical device regulations (April 2014) 3 month commentary period Draft General Guidelines Essential Principles Safety and Performance Bill 6 Revised draft medical device regulations (July 2015) 1 month commentary period 3

4 2. Regulatory Framework Key concepts Global Harmonisation Recognises regional / local nuances and health related requirements Essential Principles of Safety and Performance Risk based classification 4 classes Accreditation regulatory framework SANAS Conformity Assessment bodies Licence Authorised Representative Quality Management System 4

5 Life Cycle Approach to the Regulations of a Medical Device Stage Concept Prototype Preclinical Required regulatory action Consider the Essential Principles Incorporate the Essential Principles into the design Seek approval from or notify the Council of intention to commence clinical investigation and evaluation Clinical Follow clinical investigation guidelines Manufacturing (Establishment) Licence Registration Marketing & Distribution Supply Obsolescence Prepare clinical evaluation of clinical data Apply conformity assessment procedures and then obtain appropriate conformity assessment evidence Make application for a manufacturer licence (to manufacture, import or export a medical device or IVD) and or a wholesaler licence (to wholesale and or distribute a medical device or IVD). Quality Management System Use technical documentation, supported by certified assessment evidence, to prepare South African Declaration of Conformity and make application for inclusion of the medical device or IVD into the South African Register of Medical Devices or Register of IVDs. Adhere to Act 101 of 1965 as amended, and supporting regulations and guidelines Monitor safety and performance of the medical device or IVD during its lifetime Maintain conformity assessment evidence Report any problems with the medical device or IVD to the Council and to the users of the medical device or IVD Recall and/or correct medical devices or IVDs that have defects, design flaws, or unacceptable clinical risks or levels of performance Notify the Council so the medical device or IVD can be removed from the register. 5

6 Key Concepts & Definitions Essential principles" set out the requirements relating to the safety and performance characteristics of medical devices and IVDs as approved by Council; The worldwide adoption of fundamental design and manufacturing requirements for medical devices, (through consistent identification, selection and application of safety and performance principles to a medical device) that, when met, provide assurance the device is safe and performs to its specification, offers significant benefits to the manufacturer, user, patient or consumer, and to Regulatory Authorities, since it allows its manufacturer to design, manufacture and to demonstrate the device is suitable for its intended use. Eliminating or reducing differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments. 6

7 Classification Determining the classification of a medical device or IVD is done using a set of classification rules based on the: manufacturer s intended use of the device or IVD level of risk to patients, users and other persons (the probability of occurrence of harm and the severity of that harm) degree of invasiveness in the human body duration of use. Identical medical devices may be classified differently if they are to be used in different parts of the body. i.e. reason why the manufacturer s intended use of the device is critical to determine the appropriate classification. The intended use can be obtained from the: instructions for use (IFU) label manufacturer s advertising materials technical documentation. Controls follow the market, not the manufacturing location 7

8 Key Concepts & Definitions Control Level Classification & Risk Reg 12. (1) The following are the classes of medical devices and IVDs - (a) Class A Low Risk (b) Class B Low-moderate Risk (c) Class C Moderate-high Risk (d) Class D High Risk where risk relates to the patient or to public health. A B C D Device Risk 2) All medical devices, except custom made devices, and all IVDs shall be registered with the Council in terms of such call up notices before they may be sold or used in the Republic. (3) The classification of medical devices and IVDs shall be as determined by Council in accordance with the classification rules. (4) Where the classification of a medical device or IVD is inconclusive and places it in more than one class or between classes after following the classification rules the Council will place it in the higher of the risk classes. (5) The Council shall consider the classification of a medical device or IVD individually taking into account its design and intended use. 8

9 A Simplified Picture of Conformity Assessment (CA) & the relationships MOU SA Regulatory Authority SA Accreditation Body MCC SANAS Accredits The responsible Gate Keeper Evaluates potential Conformity Assessment Bodies on behalf of MCC vs a Standard Conformity Assessment Bodies A B C Inspect & certify Perform CA services (inspection & certification) for a manufacturer/distributor placing a product on the market in SA vs a International Standard Manufacturer / Distributor X Y Z SA Declaration of Conformity, Registers & places product on market Customer / User Purchases & uses the product 9

10 Key Concepts & Definitions Conformity assessment Conformity assessment is the demonstration that what is being supplied actually meets the requirements specified or claimed. Conformity assessment can be applied to a product (which for these purposes includes a service), a process, a system, a body or persons and includes activities such as testing, inspection and certification. The organisations undertaking these activities are referred to as conformity assessment bodies. "conformity assessment" means the systematic examination of evidence generated and procedures undertaken by the manufacturer, to determine that a medical device is safe and performs as intended and conforms to the Essential Principles of Safety and Performance for Medical Devices, as determined by Council "Conformity Assessment Body" means a body corporate or other legal entity, locally or internationally, accredited by SANAS or an international body recognized by Council, according to a standard as determined by the Council, as competent to carry out the assessment, verification and certification of medical devices or IVDs before they are placed on the market by manufacturers; 10

11 Key Concepts & Definitions Accreditation Accreditation is given when a conformity assessment body is recognised as competent, in accordance with recognised standards, to carry out specific tasks. Accreditation is used in both the regulated sector to meet the requirements of certain legislation and the voluntary area where there is no specific legislation. It is generally accepted that for an accreditation body to be authoritative it must have the support of government. In South Africa, SANAS (DTI) is the national body which audits conformity assessment bodies for accreditation to identified standards. Accreditation increases trust in conformity assessment and thus reinforces the mutual recognition of products, processes, services, systems, persons and bodies 11

12 Key Concepts & Definitions Authorised Representative "authorised representative" means any natural person, resident in the Republic of South Africa, who has the written mandate to represent a manufacturer, importer, distributor, wholesaler, retailer or service provider in the Republic and to act on his or her behalf for specified tasks with regard to the latter's obligations and in whose name the manufacturer licence, distributor licence, wholesaler licence and or certificate of registration is issued. The authorised representative is responsible for all aspects of the medical device or IVD, including performance, quality, safety and compliance with conditions of registration; 12

13 Licence 1. MANUFACTURER LICENCE: to manufacture, import, export or 2. DISTRIBUTOR LICENCE: to import, export or distribute or 3. WHOLESALER LICENCE: to act as wholesaler; of Medical Devices or IVDs a person who, in South Africa, designs, manufactures, packs, labels, assembles, reprocesses, refurbishes the goods, or arranges for another person to manufacture the goods, for supply (whether in South Africa or elsewhere); a person who imports, or arranges the importation of, the goods into South Africa; or a person who exports, or arranges the exportation of, the goods from South Africa; or a person who acts as a distributor or a wholesaler of the goods in South Africa is required to make application for a licence to manufacture, import, export or act as a wholesaler or distributor of medical devices or IVDs. 13

14 Registration of Medical Devices and IVDs "holder of a certificate of registration" (HCR) means a person in whose name a registration certificate has been granted and who is responsible for all aspects of the medical device or IVD, including quality and safety and compliance with conditions of registration; "person" means both a natural and a juristic person; "family" means a medical device comprising of the same type of device available in different models and sizes; "group" means a medical device or IVD comprising a collection of medical devices or IVDs such as a procedure pack or procedure tray or system or procedure kit, that are packaged together for a specific intended purpose and sold under a single name 14

15 3. Key Changes Draft Regulations.removed Expedited registration process for medical devices or IVDs for human or animal use Importation of medical devices and IVDs in terms of Section 15C Particulars for a prescription or order for a medical device or IVD. Returns to be furnished in respect of specified Schedule 5, Schedule 6, 7 and 8 substances contained in medical devices and IVDs. Register of specified Schedules 5, Schedule 5 and 6 substances contained in medical devices and IVDs. Skills of members of Council. Batch release for priority IVDs. 15

16 4. What to do?. Best Practice Submit comments wrt revised draft Regulations Prepare. QMS.. Post Market Surveillance STeD Authorised Representative 16

17 Thank You! Jane Rogers Strategic Healthcare Solutions (Pty) Ltd. +27 (0) PO Box 1396, Morningside, Sandton, 2057 South Africa Reg. 2013/104488/07