INTRODUCTION TO HALAL MEDICAL DEVICE. 9 TH Halal Certification Bodies Convention 2018 April 2018

Transcription

1 INTRODUCTION TO HALAL MEDICAL DEVICE 9 TH Halal Certification Bodies Convention 2018 April 2018

2 INTRODUCTION Understanding medical devices and its regulatory requirements Understand WHY the need for a standard for halal medical devices -Understand the role of each of the stakeholders in developing the halal medical devices -Understand how the requirements of the standard in the certification of halal medical devices -Understand the certification and regulatory process governing halal medical devices. Way forward

3 Definition What is a medical device? Medical device is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease; compensation for an injury; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices; providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means Medical Devices Bureau MINISTRY OF HEALTH MALAYSIA

4 Source: Malaysia Statistics Department, MITI, MIDA, PEMANDU Malaysia Exports of Medical Devices 7% 5% 11% Medical 12% RM RM Devices 12% (Excluding 13% 2.3 Billion Billion Gloves) 12% Gloves Others Orthopedic implants Electro mechanical MD Contraceptives Catheters, syringes, needles & sutures Ophthalmic Radiation devices 28% Reusable instruments Total Exports in 2011: RM11.7 Billion

5 Medical Device Industry Ecosystem in Malaysia Materials: Rubber, Plastics, Steel, Electronics, etc. Consumables Surgical Instruments, Implants & Clinical Devices Healthcare Equipment Technology Latex Plastic Metal Machining Electronics Furniture Products Glove, Contraceptives, Catheters, woundcare, Orthalmology, IVD, SUD Pacemaker, Orthopedics, Surgical instrument Radiation equipment, Life Science Instrument, Electrodes, Hospital beds Companies Supporting Infrastructure Sterilization Packaging Certification Biocompatibility And Clinical Trial Industry Group Education Training Regulatory UKM, Info Kinetics UM, USM, UKM, UniMap, PSDC, Medsociate, Neville Clarke Medical Device Act 2012

6 The regulation of Medical Devices in Malaysia Integral part of the health care delivery system Important in terms of safety and effectiveness of the medical device It is well regulated through its regulatory framework Under the current laws, (Act 737) Malaysia has in place a national regulatory system designed to protect public health and ensure safety and performance Thus the system ensures that the medical device its safety and performance is maintained throughout its lifespan The regulatory framework is well harmonised with international forums Current national law in Malaysia requires each establishment to be licenced and the medical device registered

7 Medical Device Lifecycle What are the Regulatory Activities?

8 Overview of The Regulatory System PRE-MARKET PLACEMENT ON-MARKET POST-MARKET PRE-MARKET REVIEW Manufacturers of medical devices shall - ensure their products conform to EPSP ensure their products are manufactured in accordance with GMP collect evidence of conformity CAB verifies evidence of conformity MEDICAL DEVICES REGISTRATION Manufacturers (or LARs) apply for register medical devices & establishment license to manufacture DISTRIBUTORS LICENSING Distributors shall - ensure compliance to GDP & advertising requirements apply for establishment license to distribute medical devices MDA allows - registered medical devices to be placed into the market licensed establishments to do their business MEDICAL DEVICES WILL BE MADE AVAILABLE ON THE MARKET SURVEILLANCE & VIGILANCE Establishments shall- monitor safety & performance of their products carry out post-market obligations, eg user training, complaint handling, FSCA, recall USAGE & MAINTENANCE Users shall use, maintain & dispose off medical devices appropriately Users shall apply for permit to use/operate designated medical devices MDA monitors compliance to requirements & takes appropriate actions in accordance with the provisions of the law

9 MEDICAL DEVICES LIFE CYCLE IN HEALTHCARE FACILITIES Establishments licenced Devices registered Disposal Replacement Planning, User requirements Procurement Device Assessment-HTA MDA register devices and license establisments Maintenance Installation/Testing & Commissioning/Acceptance Use Devices Inventory of Hosp Field Safety Corrective Actions Incident reporting Training

10 Why the need for Halal Medical Devices Standard Demand in proposals for specific new products Changing of classification of medical products For certification purposes by the halal certification body Hence there is a need for a standard on Halal to be developed for medical devices

11 Use of Halal Standard on Medical Devices New Proposals for development of Malaysian Standard:- as an example on Halal Synthetic Bone Graft and other Halal Medical Devices received prior to Pharmaceutical products that were reclassified as Medical devices could not continue to be certified halal under MS 2424 and this caused confusion in consumers. Enables certification bodies to certify Halal for medical devices

12 Objectives of the Standard Is to assist industry in obtaining halal certification, not to mandate Develop a standard that is implementable according to the Syariah laws No testing of products but built into the entire system

13 Main Benefits of the Standard Enables pharmaceutical products that were reclassified as medical devices to be certified halal under the new scheme to be developed by JAKIM The Standard is voluntary Safety and performance is assured as the products need to be registered and the establishments licensed by MDA as the main requirement of all medical devices is its safety and performance as such, all medical device has to comply with the Medical Device Act 2012 (Act 737) before it can be certified halal.

14 FRAMEWORK OF HALAL MEDICAL DEVICE CERTIFICATION Department of Standards Malaysia Owner of Malaysian Standards Medical Device Authority Regulates Medical Devices JAKIM Halal competent authority (together with various State Islamic Religious Councils) Determines scope of halal certification through offering of schemes Certifies and monitors halal certifications 14

15 SCOPE OF CERTIFICATION To be determined by JAKIM following internal procedures Priority to be given to medical devices that were reclassified from pharmaceuticals

16 MS ON HALAL MEDICAL DEVICE: Committee representation Foreword Introduction Scope Normative references Terms and definitions Compliance Halal certificates Halal certification logo Annex A Method of washing and sertu according to Shariah law for najs al-mughallazah CONTENTS Requirements Quality management Management responsibility Halal Assurance Management System Fundamentals for halal medical devices Halal quality control Personnel and responsibility Training Personal hygiene Manufacturing premise and equipment Manufacturing and storage areas Quality control areas Ancillary areas Documentation Manufacturing Materials Packaging, labelling and advertising Outsourced activities Self-inspection Legal requirements 16

17 Introduction to meet the challenges of the growing demand for halal products and services to complement the halal ecosystem based on the concept of halal built-in Not tested into products, but built-in into the entire system Obtaining halal certification is a business strategy and is seen as a value added element. 17

18 SCOPE OF THE STANDARD This Malaysian Standard specifies the requirements in the manufacturing and handling of particular medical devices as specified by the halal competent authority for the purpose of halal certification. SCOPE OF CERTIFICATION SHALL BE DETERMINED BY JAKIM 18

19 3. TERMS AND DEFINITION 3.1 competent authority The competent authority for medical device is the Medical Device Authority established under Medical Device Authority Act 2012 (Act 738) 3.4 halal competent authority In Malaysia, the halal competent authorities are JAKIM and the various State Islamic Religious Councils 19

20 4. REQUIREMENTS 4.1 Quality management The manufacturer shall ensure that the medical device for halal certification are manufactured in accordance with ISO

21 4.2 MANAGEMENT RESPONSIBILITY The management shall: ensure that the halal assurance management system shall be comprehensively designed, developed, implemented, monitored and maintained to incorporate application of halal and ISO appoint muslim halal executive and establish an internal halal committee who is responsible to ensure the effectiveness in implementation of internal halal control system. provide training regularly to relevant personnel on the halal principles and its application. ensure that sufficient resources (i.e. manpower, facility, financial and infrastructure) are provided. ensure all related activities for manufacturing and handling of halal medical devices are properly recorded. All documents and records shall be maintained and traceable. allow the workers to fulfill the obligation of their religious practice. ensure that the participation and commitment by staffs in various departments and at all levels within the company, the company s suppliers and distributors. 21

22 3.8 INTERNAL HALAL COMMITTEE (IHC) 3.8 A committee established by the organisations to be responsible for developing, monitoring and controlling the halal assurance management system to ensure its effectiveness. 22

23 4.3 HALAL ASSURANCE MANAGEMENT SYSTEM The halal assurance management system shall be appropriate for the manufacturing of halal medical devices and shall be ensured that: a) the medical devices are designed and developed to comply with the requirements of halal and ISO 13485; b) the production and control operations are clearly specified and in compliance with ISO 13485; c) the processing line shall be operated for halal medical devices only and in the case of converting the processing line which contained or contaminated with najs al-mughallazah to a halal production line then the sertu method by Shariah law shall be required. 23

24 4.4 FUNDAMENTALS FOR HALAL MEDICAL DEVICES The requirements described in the ISO are integral part of the standard and shall be referred to for the recognition for halal medical devices. The main control point is on the source of materials, equipment and utilities that is in direct contact with the products All records shall be maintained. Any significant deviations shall be fully investigated and documented. All records of manufacturing including distribution which enable the complete history of a batch to be traced are retained and maintained in a comprehensible, legible and accessible form. 24

25 FUNDAMENTALS FOR HALAL MEDICAL DEVICES All materials are clearly defined with evidence of complying with Shariah law and fatwa. All necessary facilities and resources for halal compliance are provided including availability of: i) qualified and competent personnel; ii) adequate premises, spaces, utilities and services; iii) dedicated equipment and production lines; iv) materials, containers and labels approved by IHC; v) procedures and instructions approved by IHC; and vi) dedicated storage and transport 25

26 FUNDAMENTALS FOR HALAL MEDICAL DEVICES The distribution of the products minimises any risk to their halal integrity. A post-market halal surveillance system is established and maintained. Any complaint about marketed products are examined and the causes of halal non-compliance investigated. The appropriate measures in respect of the non-compliance are taken and shall prevent re-occurrence. 26

27 4.5 HALAL QUALITY CONTROL Halal quality control is to ensure all materials used in manufacturing and laboratory are halal compliant. The purchase, handling and sourcing of chemicals, reagents, apparatus, equipment and other items required for sampling and testing shall not be made from any source that is decreed as non-halal by Shariah law and fatwa. 27

28 4.6 PERSONNEL AND RESPONSIBILITY 4.7 TRAINING The organisation shall ensure that there are sufficient qualified and competent personnel available to establish and maintain a satisfactory halal assurance management system. All personnel shall be aware of the principles of halal and receive initial and continual training relevant to their needs. training programmes shall be developed which include halal related training to ensure personnel involved in the operation are trained and/or instructed to a level appropriate to the operations to be performed. Continual training shall be given, and the practical effectiveness shall be periodically assessed. The training programmes shall be available and approved by the internal halal committee. All training records shall be maintained.

29 4.8 PERSONAL HYGIENE Strict personal hygiene is an integral requirement for halal and shall be adequately addressed, and in compliance with ISO

30 4.9 MANUFACTURING PREMISE AND EQUIPMENT manufacturing premise shall be situated in an environment which, when considered together with measures to protect the manufacturing process, presents no risk of causing contamination of non-halal materials or products. The layout and design shall conform to the requirements of the ISO The manufacturing premise shall be effectively separated and well insulated from pig, dog and other animal farm activities and others, in order to prevent cross contamination through air, water, sewerage, personnel and equipment. The manufacturing premise shall not have any presence of non-conformance items such as non halal food and beverages. The manufacturing facility shall not have any tool and elements of religious worship. 30

31 MANUFACTURING PREMISE AND EQUIPMENT Repetition in converting the production line to najs almughallazah line and back to halal line, shall not be permitted. Pets and other animals shall be prohibited from entering the manufacturing premises. 31

32 4.10 MANUFACTURING AND STORAGE AREAS 4.12 QUALITY CONTROL AREAS 4.13 ANCILLARY AREAS There shall be dedicated and self-contained facilities available for the manufacturing and storage of halal medical devices to avoid the risk of nonhalal contamination. When handling and conducting quality control activities in the manufacturing area, the operations for control laboratories shall take precaution to prevent contamination on production line which may cause product to be non-halal. Muslim praying area shall be provided and appropriately located. Animal houses shall be well isolated from other areas, with separate entrance (animal access) and air handling facilities. 32

33 4.11 TRANSPORTATION Transportation vehicles shall be dedicated and appropriate to the type of the halal medical device and satisfy hygiene and sanitation condition. 33

34 4.14 Documentation The halal assurance management system shall be documented including evidence of materials origin and shall be approved, signed and dated by the internal halal committee. The documents required for the materials shall include but are not limited to: a) halal certificates from recognised certification bodies; b) product data sheet which contains complete description on the source or origin of materials and method of processing; and c) manufacturing formula and processing instructions. 34

35 4.15 MANUFACTURING 4.16 MATERIALS The manufacturing operations shall follow clearly defined documented procedures and comply with halal principles. All materials used in manufacturing of medical devices shall comply with halal requirements. Materials may be from synthetically or naturally derived sources or genetically modified organisms (GMO). All najs are prohibited. 35

36 SYNTHETIC MATERIALS NATURAL MATERIALS PLANTS Synthetic materials The sources and processing of synthesized materials shall comply with halal requirements. The usage of synthetic ethanol is permissible. Natural materials The usage of all natural materials such as plants, animals, minerals, microorganisms, naturaloccuring chemicals and genetically modified organisms (GMO) may be used in medical devices as approved by the competent authority. Natural materials that are poisonous, intoxicating or hazardous for health may also be used for medical purposes as approved by the competent authority. Plants All types of plants and plant products and their derivatives are halal except those prohibited by the competent authority. 36

37 ANIMALS LAND ANIMALS All land animals are halal except for the following: animals that are not slaughtered according to Shariah law; najs al-mughallazah animal, i.e. pigs, dogs and their derivatives; animals with long pointed teeth or tusks which are used to kill prey such as tigers, bears, elephants, cats, monkeys, etc.; predator birds such as eagles, owls and etc.; pests and/or poisonous animals such as rats, cockroaches, centipedes, scorpions, snakes, wasps and other similar animals; animals that are forbidden to be killed in Islam such as bees (al-nahlah), woodpeckers (hud-hud), etc.; creatures that are considered repulsive such as lice, flies, etc.; farmed halal animals which are intentionally and continually fed with najs; other animals forbidden to be eaten in accordance with Shariah law and fatwa; and other animals that are prohibited by the competent authority. 37

38 ANIMALS AQUATIC ANIMALS All aquatic animals are halal except those that are poisonous, intoxicating or hazardous to health; animals that live both on land and water such as crocodiles, turtles and frogs; animals which live in najs or intentionally and/or continually fed with najs; and Other aquatics animals forbidden to be eaten in accordance with Shariah law and fatwa. 38

39 MICRO-ORGANISMS NATURAL-OCCURING CHEMICALS GMO Micro-organisms Microscopic organism ranging from 10-6µ to 10-9µ of medical interest include bacteria, rickettsiae, viruses, fungi and protozoa. All micro-organisms are halal except those prohibited by the competent authority. Natural-occurring chemicals All natural-occuring chemicals are halal except those prohibited by the competent authority. Genetically modified organisms (GMO) Products and/or by-products of genetically modified organisms (GMOs) or ingredients made by the use of genetic material of animals that are decreed as halal by Shariah law.

40 4.17 PACKAGING, LABELLING Halal medical devices shall be suitably packed. Packaging materials shall be halal and fulfill the following requirements: a) the packaging materials shall not be made from any raw materials that are decreed as najs by Shariah law and fatwa; b) it is not prepared, processed or manufactured using equipment that is contaminated with najs as decreed by Shariah law and fatwa; c) during its preparation, processing, storage or transportation, it shall be segregated from any other materials that does not meet the requirements stated in item a) or b); d) the packaging material does not have any toxic effect on the halal medical devices; e) packaging design, sign, symbol, logo, name and picture shall not be misleading and/or contravening the principles of Shariah law and fatwa; f) packing process shall be carried out in a clean and hygienic manner and in sound sanitary conditions; and g) labelling material used in contact with primary packaging of halal medical devices shall be non-hazardous and halal. Packaging shall not display indecent elements and contravene with the principles of Shariah law and fatwa as well as Medical Devices 2012 (Act 737) and its subsidiary regulations. 40

41 4.18 OUTSOURCED ACTIVITIES 4.19 INTERNAL AUDIT 4.20 LEGAL REQUIREMENTS Outsourced activities shall be correctly defined, agreed and controlled in order to avoid misunderstandings. Outsource activities shall result in a product or work of satisfactory quality and that is decreed as halal by Shariah law and fatwa. There shall be a written contract between the contract giver and the contract acceptor which clearly establishes the duties of each party which include complying with the halal requirements. Internal audit shall be conducted annually in order to monitor the implementation and compliance with halal and ISO and to propose necessary corrective measures. Halal medical devices shall comply with legislation including other relevant requirements currently in force in Malaysia and/or producing country. 41

42 5 COMPLIANCE This standard shall be used to demonstrate compliance towards certification of halal medical devices by the halal competent authority. The procedure and requirements for certification will be as specified by the halal competent authority. 42

43 6 HALAL CERTIFICATES 7 HALAL CERTIFICATION LOGO The halal certificates shall be issued by the halal competent authority in Malaysia. Each halal medical device, upon approval by the competent authorities in Malaysia, shall be marked with the halal certification logo of that authority provided the product conforms to the requirements of this standard. 43

44 Thank You