Overview of Regulatory Framework for Medical Devices & IVDs and likely Implementation Roadmap. Jane Rogers SAAPI Conference 13 April 2016

Transcription

1 Overview of Regulatory Framework for Medical Devices & IVDs and likely Implementation Roadmap Jane Rogers SAAPI Conference 13 April 2016

2 Regulatory Framework for Medical Devices & IVDs HAZARDOUS SUBSTANCES ACT 15 of 1973 (as amended) Historically, only electronic medical devices were controlled in South Africa Licensing from the Directorate of Radiation Control is required in order to import medical devices which incorporate / utilise a source of energy (including electro medical & radiation devices) into the country. Authorization for these devices in South Africa requires prior EU approval.

3 Regulatory Framework for Medical Devices & IVDs Act 101 of 1965 (as amended) Act 14 of 2015 Key changes: Transition from Medicine Control Council (MCC) to South African Health Products Regulatory Authority (SAHPRA), the operations & function thereof Clarity wrt regulatory control of medical devices, including licensing, registration, labelling, advertising, bonusing, sampling, marketing code of practice disposal of undesirable MDs appeals process, penalties specific regulation for medical devices & IVDs, and transitionary matters

4 Regulatory Framework - changes (cont.) New Regulations for Medical Devices and IVDS (to be finalised) Licensing of medical device establishments Manufacturing (including importation and refurbishing); Distributors of Medical Devices (including importers) Wholesalers

5 Regulatory Framework - changes (cont.) New Regulations for Medical Devices and IVDS (to be finalised) Licensing of medical device establishments Manufacturing (including importation and refurbishing); Distributors of Medical Devices (including importers) Wholesalers Authorised Representative

6 Regulatory Framework - changes (cont.) New Regulations for Medical Devices and IVDS (to be finalised) Licensing of medical device establishments Manufacturing (including importation and refurbishing); Distributors of Medical Devices (including importers) Wholesalers Authorised Representative Registration of the medical device / IVD Compliance with essential principles of safety & performance Conformity assessment Standards Requirements for labelling, instructions for use, advertising; Risk classifications (A, B, C, D) determined by Council / Authority;

7 Regulatory Framework - changes (cont.) New Regulations for Medical Devices and IVDS (to be finalised) Licensing of medical device establishments Manufacturing (including importation and refurbishing); Distributors of Medical Devices(including importers) Wholesalers Authorised Representative Registration of the medical device / IVD Compliance with essential principles of safety & performance Conformity assessment Standards Requirements for labelling, instructions for use, advertising; Risk classifications (A, B, C, D) determined by Council / Authority; Post-market surveillance, adverse event reporting;

8 Regulatory Framework - changes (cont.) New Regulations for Medical Devices and IVDS (to be finalised) Licensing of medical device establishments Manufacturing (including importation and refurbishing); Distributors of Medical Devices (including importers) Wholesalers Authorised Representative Registration of the medical device / IVD Compliance with essential principles of safety & performance Conformity assessment Standards Requirements for labelling, instructions for use, advertising; Risk classifications (A, B, C, D) determined by Council / Authority; Post-market surveillance, adverse event reporting; Regulation of clinical trials & clinical performance studies NOTE: Regulations are supported by Guidelines - some of which have been published for comment

9 Essential Principles of Safety & Performance 9

10 Essential Principles of Safety & Performance 1. Use of medical devices not to compromise health and safety 2. Design and construction of medical devices to conform to safety principles 3. Medical devices to be suitable for intended purpose 4. Long-term safety 5. Medical devices not to be adversely affected by transport or storage 6. Benefits of medical devices to outweigh any side effects PRINCIPLES ABOUT DESIGN AND CONSTRUCTION (9) 7. Chemical, physical and biological properties 8. Infection and microbial contamination 9. Construction and environmental properties 10. Medical devices with a measuring function 11. Protection against radiation 12. Medical devices connected to or equipped with an energy source 13. Information to be provided with medical devices. 14. Clinical evidence 15. Principles applying to IVD medical devices only 10

11 Principles of Classification in the South African context 11

12 4 Risk based classes where risk relates to the patient or user or to public health Class Risk Medical Device Examples IVD Examples A Low individual risk & minimal or no public health risk Surgical retractors/tongue depressors Reagents, instruments, specimen receptacle, microbiological culture medium B Low-moderate Hypodermic needle/suction equipment Pregnancy self-test kit, urine self-test strips to detect glucose; biochemistry tests for blood gases, hormones, vitamins C Moderate-high Lung ventilator/orthopaedic implants Malaria rapid test; Human genetic testing, STD test; Prenatal screening tests, tumour markers, self monitoring of blood glucose D High Heart valves/implantable defibrillator Screening for HIV / Hepatitis B; detection of Rhesus markers; testing red blood cell antigens or antibodies within ABO blood group system 12

13 Classification Rules for Medical Devices Classification is intended to determine the level of regulatory control based on risk assessment There are principles and factors to be considered before assigning the classification Classification is a critical activity! 13

14 Rules based system The Manufacturer should: a) Decide if the product is a medical device or IVD, based on the definition, and b) the intended use of the medical device or IVD. c) Consider all the rules in order to establish the proper classification for the device (if a medical device has features that place it into more than one class, classification and conformity assessment should be based on the highest class indicated). 14

15 IVD Rules 15

16 Registration activities and application The Registration process utilises qualified third party conformity assessment followed by application for addition to the Medical Device / IVD register. Information required will include: Classification of the medical device; Certification of conformity of the medical device to the Essential Principles (risk based); Declaration of Conformity by the SA Authorised Representative; Labelling and Instruction for Use (IFU) including the intended use; Technical Documentation details of which are not yet clarified. Likely to align to the IMDRF harmonized Table of Contents (RPS) - electronic format to be confirmed

17 Post market surveillance requirements The Medical Device & IVD regulations require post market surveillance and reporting This includes: The medical device establishment must have formal procedures in place (as part of QMS) to record, review, report to the Council / Authority and implement appropriate corrective actions relating to adverse events and product complaints. Draft Guidelines for Adverse event and post marketing vigilance reporting of medical devices and IVDs and Recalls were published for comment.

18 In Summary: Regulatory control of Medical devices Pre market: 1a) License to Manufacture, Import & distribute or export; or Wholesale medical devices and IVDs Refer Act 101 Section 22C (1)b 1b) Registration of medical devices and IVDs - using conformity assessment framework. Post market: QMS: ISO13485 (2016) 2. Post market surveillance & reporting

19 How are controls likely to be implemented? Refer Act 101 Section 22C (1)b STEP 1: LICENSING Regulations specific to Medical Devices & IVDs are to be finalised & published in the Gov Gazette with dates for implementation of the Regulations -?? 2016 Step 2: REGISTRATION of High Risk (new) medical devices

20 Licence to Manufacture. Import, Export or Distribute Medical Devices & IVDs activities & application On implementation of the guideline there will be six months to make application to license a medical device establishment. Requirements include providing: Full details of the Authorised Representative and company; Confirmation of the existence of a Quality Management System (in time this is likely to change to become a QMS certified to ISO13485); Full list of medical devices / IVDs marketed in SA by classification group; For Class C & D medical devices / IVDs evidence of pre-market approval in at least one of USA FDA or Health Canada or EU (CE market) or TGA or Japan or ANVISA Brazil or WHO Pre-qualification for IVDs = originating approval(s) A free sales certificate; Summary Technical Documents (STeD) for Class C and Class D medical devices and IVDs. Licence holders must be able to provide full technical documentation on request by the Authority; Where relevant, certificate of conformance / analysis.

21 Implementation approach Licence to a) manufacture; b) Import & distribute or c) Wholesale Six months notice: Authorised Representative Quality Management System ----> ISO13485 (2016) Full list of Medical Devices by company & classification Class C & D: Evidence of pre-market approval in either: USA (FDA); EU (CE marking); Japan; Canada; Australia; Brazil or WHO Pre-Qualification IVD Registration - New High Risk Medical Devices (Class D, Class C) Technical Documentation including quality standard certifications depending on risk classification SA Authorised Rep s Declaration of Conformance Call up Registration of High risk Medical Devices SANAS: Development of Conformity Assessment Framework for Medical Devices ISO (2016) 21

22 What is current state of readiness? 22

23 Crosby s Quality Management Maturity Grid Stage 1: Stage 2: Stage 3: Stage 4: Stage 5: Uncertainty Awakening Enlightenment Wisdom Certainty Management understanding and attitude No comprehension of quality as a management tool. Tend to blame quality department Recognising that quality management may be of value but not willing to While going through quality improvement programme learn more about quality Participating. Understand absolutes of quality management. Recognise Consider quality management as an essential part of company system. for "quality problems". provide money or time to management; becoming their personal role in make it all happen. supportive and helpful. continuing emphasis. Quality organisation status Quality is hidden in manufacturing or A stronger quality leader is appointed but main Quality department reports to top management, all Quality manager is an officer of company; effective status Quality manager on board of directors. Prevention is main engineering departments. emphasis is still on appraisal appraisal is incorporated and reporting and preventive concern. Quality is a thought Inspection probably not part and moving the product. Still manager has role in action. Involved with leader. of organisation. Emphasis on part of manufacturing or management of company. customer affairs and special appraisal and sorting. other. assignments. Problem handling Problems are fought as they Teams are set up to attack Corrective action Problems are identified early Except in the most usual occur; no resolution; major problems. Long-range communication established. in their development. All cases, problems are inadequate definition; lots of solutions are not solicited. Problems are faced openly functions are open to prevented. yelling and accusations. and resolved in an orderly suggestion and way. improvement. Cost of quality as % of sales Reported: Unknown Actual: 20% Reported: 3% Actual: 18% Reported: 8% Actual: 12% Reported: 6.5% Actual: 8% Reported: 2.5% Actual: 2.5% Quality improvement actions No organised activities. No understanding of such Trying obvious "motivational" short-range efforts. Implementation of a multistep programme (e.g. Continuing the multi-step programme and starting Quality improvement is a normal and continued activities Crosby's 14-step) with other pro-active / preventive activity. thorough understanding and product quality initiatives. establishment of each step. Summary of company quality posture "We don't know why we have problems with quality". "Is it absolutely necessary to always have problems with quality?" "Through management commitment and quality improvement we are "Defect prevention is a routine part of our operation." "We know why we do not have problems with quality." identifying and resolving our problems."

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25 Questions?