MEDICAL DEVICE REGULATION

- MEDICAL DEVICE REGULATION

OVERVIEW AND GUIDING PRINCIPLES

Ir Prof. Albert POON

Department of Biomedical Engineering
Jan 2024
 Contents Page
MEDICAL DEVICE REGULATION
1. Introduction and Definition
2. Why Regulate?
3. The GHTF Model for Medical Device Regulation
4. Regulatory - Terms and Glossary
5. WHO GuideBooks for MD Regulatory Program
6. Medical Device Safety
7. Regulatory through MD Life Cycle & Implementation
8. WHO Global Regulatory Framework for MD including IVD
9. An International Model for MD Regulatory Framework
10. Harmonization Efforts*

2
Lecture on Medical Device Regulation
 MEDICAL DEVICE REGULATION

Introduction and Definitions

n Regulation is primarily concerned with enabling patient
access to safe, effective and quality medical devices,
and restricting access to those products that are
unsafe or have limited clinical use.
n When appropriately implemented, regulation ensures
public health benefit and the safety of patients, health
care workers and the community through regulatory
guidance, training, coordination and promotion of
international best practices.

3
Lecture on Medical Device Regulation
 WHY REGULATE

n MD regulation is enforced in order to upkeep the standards

for safety, efficacy, quality and accessibility of quality
medical device products to patients and the community for
the intended use of the product.
n Regulation specifies the regulatory controls and
requirements on the MD products and thus ensure proper
implementation of the SEQA and EPs required.
n Provides proper requirements on labelling, risk
classification and identification of the device products
n Ensures transparency and information openness to
patients of product safety and potential risk of application.

4
Lecture on Medical Device Regulation
 MEDICAL DEVICE REGULATION

Safety Govern
S-E-Q-A Efficacy
ment

Medical
EP Devices
ESSENTIAL
PRINCIPLES OF Quality
SAFETY & Public
PERFORMANCE Health &
Access Safety
by
Patient

5
Lecture on Medical Device Regulation
 GHTF
Global Harmonization Task Force (GHTF) was created in 1992
by Canada, European Union, Japan, USA and Australia and is
known as the “Father of MD Regulation & Harmonization”

• Informal forum for regulators and industry of medical devices and IVDs
• Consisted of a Steering Committee, 5 Study Groups and several Ad Hoc
Working Groups
• Has links with several partners including: ISO, IEC, WHO, PAHO, AHWP
and LAHWP

Re-structured in 2012 and regulators only changed to form

International Medical Device Regulators Forum (IMDRF). See
www.imdrf.org
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Lecture on Medical Device Regulation
 THE THEN GHTF (PRIOR 2012)

GHTF Steering Committee, with rotation of Chairmanship and

secretariat
5 Study Groups
n SG1 – Pre-market Evaluation
n SG1, IVD Subgroup – Pre-market Evaluation for IVDD
n SG2 – Post-market Surveillance/ Vigilance
n SG3 – Quality Systems
n SG4 – Auditing
n SG5 – Clinical Safety/ Performance

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Lecture on Medical Device Regulation
 DEFINITION FOR MEDICAL
DEVICES

n The Global
Harmonization Task
Force proposed
harmonized definition for
medical devices (see
GHTF document
SG1/N029R13) is
adopted

8
Lecture on Medical Device Regulation
 DEFINITION FOR MEDICAL
DEVICES
“Medical device” means any instrument, apparatus, implement, machine,
appliance, implant, in vitro reagent or calibrator, software, material or other
similar or related article, intended by the manufacturer to be used, alone or
in combination, for human beings for one or more of specific purposes of:
n • diagnosis, prevention, monitoring, treatment or alleviation of disease
n • diagnosis, monitoring, treatment, alleviation of or compensation for an
injury
n • investigation, replacement, modification, or support of the anatomy or of
a physiological process
n • supporting or sustaining life
n • control of conception
n • disinfection of medical devices
n • providing information for medical purposes by means of in vitro
examination of specimens derived from the human body and 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 function by such means.
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Lecture on Medical Device Regulation
 Definition of MD (Cont’d)

n Note 1: Products which may be considered to be medical

devices in some jurisdictions but for which there is not yet a
harmonized approach, include:
Ø disinfection substances,
Ø aids for persons with disabilities,
Ø accessories to a medical device (see Note 2),
Ø components of a medical device,
Ø devices incorporating animal and/or human tissues.
n Note 2: Some jurisdictions include accessories to a medical
device within the definition of a medical device. Other
jurisdictions do not adopt this approach but still subject an
accessory to the regulatory controls (e.g. classification,
conformity assessment, quality management system
requirements etc.) that apply to medical devices.

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Lecture on Medical Device Regulation
 DEFINITION FOR DEVICE
EFFECTIVENESS / PERFORMANCE

n Effectiveness means clinical effectiveness

n Efficacy generally means effectiveness under an ideal
controlled setting.
n Performance means technical performance including
clinical effectiveness
_________________________________________________
n A device is clinically effective when it produces the effects
intended by the manufacturer relative to the medical
condition.
n Direct effectiveness (DE) refers to objective evidence of
the intended purpose.
n Relative effectiveness (RE) is the comparison of DE with
that of other similar devices

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Lecture on Medical Device Regulation
 GLOSSARY

n Manufacturer, Distributor, Vendor

n Person (Legal person)
n Effectiveness, Efficiency and Performance
n Act, Law, Ordinance, regulation, code of practice
n Nomenclature Systems
n Unique Device Identifier (UDI), Bar Code (GS1)

n Custom-made device
n Control number (lot, batch, serial for traceability)
n IFU (Instructions), DFU (Directions) and Package Insert (PI)
n Recall, safety incident and near miss
n Product validation
n Process validation
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Lecture on Medical Device Regulation
 GLOSSARY (CONT’D)

n Safety and Effectiveness requirements

n Clinical trial and Objective evidence
n Significant change
n Implants and device traceability records
n Medical Device, MD Group (Kit) and MD Family
n Active Device, Diagnostics and Therapeutics

n Body orifice
n Invasive device, Surgically invasive
n In-vitro Diagnostics Device (IVDD)
n Near patient IVDD’s; Point of Care (POC)
n Central Cardiovascular System
n Central Nervous System
n Closed loop system
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Lecture on Medical Device Regulation
 WHO - BLUE BOOK

The International Guide

1.The primary goal is to protect public health and safety.

2. New technologies are made available to the clinical
community and to patients
3. Regulatory decisions based on clear science and
consistent with the directives of law.
4. Enforcement of the law must be vigorously, fairly and
uniformly carried out
5. Government-protected rules and procedures must be
clearly articulated for those who must comply with
them.
6. Assuring medical device safety requires oversight of
the use of medical devices.
7. Information on product risks must be openly
communicated with health professionals and
consumers.
8. Countries instituting medical device programs should
be cognizant of ongoing international harmonization
efforts.
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Lecture on Medical Device Regulation
 WHO – GREEN BOOK

The Global Overview & Guiding Principles

1. Definition of Medical Device

2. Medical Device Safety

3. Standards

4. Regulation of Medical Devices

5. Optimising Use of Regulatory Resources

6. International Harmonization Efforts

7. Priorities on International Agenda

(Author: Canadian Chinese Mr. Michael CHENG)
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Lecture on Medical Device Regulation
 DEVELOPMENT OF MD REGULATION
THE RED BOOK

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Lecture on Medical Device Regulation
 WHO RED BOOK – A Guide for
DEVELOPMENT OF MD REGULATIONS

1. Introduction

2. Nature of Medical Device Safety

3. Government Regulation of Medical

Devices

4. Global Harmonization Task Force

5. Optimising Use of Regulatory Resources

6. Interpreting MD “Export Certificates”

17
Lecture on Medical Device Regulation
 Medical Device Safety
(Introducing QMS and RMS)

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Lecture on Medical Device Regulation
 MEDICAL DEVICE SAFETY

n The nature of medical device safety is a risk management

process that must encompass the life span of medical
devices from their conception to disposal. A Life Span
Diagram facilitates understanding and serves as a memory
anchor. (Refer to later slides)
n Optimum safety and performance require cooperation
among all those involved in the life span of a medical
device: the manufacturer, importer/vendor, government,
user and public – each stakeholder has a specific role to
play in risk management.

RM
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Lecture on Medical Device Regulation
 MEDICAL DEVICE SAFETY

Re-cap - The optimum assurance of medical device safety

has several essential elements:
n • Absolute safety cannot be guaranteed
n • It is a risk management issue
n • It is closely aligned with device effectiveness/
performance
n • It must be considered throughout the life span of the
device
n • It requires shared responsibility among the stakeholders
n IEC 60601-1

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Lecture on Medical Device Regulation
 DEVICE SAFETY AND RISK
MANAGEMENT

n Hazard is a potential for an adverse event, a source of

danger. Risk is a measure of the combination of
(1) the hazard;
(2) the likelihood of occurrence of the adverse event;
(3) the severity or overall impact.
n Risk assessment begins with risk analysis to identify all
possible hazards, followed by risk evaluation to estimate
the risk of each hazard.
n In general, risk assessment is based on experience,
evidence, computation, or even guesswork.
n In practice, risk assessment of medical devices is based
on the experience of health care professionals and on
safety design engineering.
n ISO 13485 (QMS) plus ISO 14971 (RMS)
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Lecture on Medical Device Regulation
 HAZARD, RISK AND SAFETY OF MD

n Hazard is a condition that could jeopardize safety, a source of

potential danger
n Risk is a measure of the incidence, likelihood and severity of a hazard
n A medical device shall be designed and manufactured to be safe and
manufacturer shall take measures to
1. Identify the risks inherent in the device
2. If the risks can be eliminated, eliminate them;
3. If the risks cannot be eliminated,
- Reduce the risks to the extent possible
- Provide appropriate protection and include alarms
- Provide device information related to any remaining risks
n Minimise hazard from the potential failures during the projected useful
life of the device
n Acceptable risk when weighed against the benefits to patient
22
Lecture on Medical Device Regulation
 Regulation through
Medical Device Life Cycle

23
Lecture on Medical Device Regulation
 PRODUCT LIFE SPAN OF
A MEDICAL DEVICE

2.Manufacture
1. Conception
3. Packaging and
and Development
Labeling

Medical 4.Advertising
7.Disposal
Device

6.Use 5.Sale

24
Lecture on Medical Device Regulation
 CRITICAL ELEMENTS FOR
REGULATORY ATTENTION

n 1. Product
Pre-market review contributes to product control
n 2. Presentation of Product to User
This is controlled through labelling (during the pre-
market stage) and advertising of the product
n 3. Use
Post-market surveillance ensures that medical devices
in use continue to be safe and effective.

n The control of these three critical elements by

relating them to the Product Life Span diagram

25
Lecture on Medical Device Regulation
 REGULATORY TOOLS

Pre-market (Some examples)

n Product Design Control (Part of QSR)
n Product listing or register by regulator
n Approval number (CE12234, HKMD1234)
n Device License
n Compliance Label or Mark (e.g. CE Mark)
n Manufacturer Notification
n Approval Letter (PMA)
n Market Clearance (510K)
26
Lecture on Medical Device Regulation
 REGULATORY TOOLS

Placing on market
n Establishment control and listing or registration
n Establishment License
n Responsible Person Registration
n Manufacturer License
n Importer License
n Enterprise Identification

27
Lecture on Medical Device Regulation
 REGULATORY TOOLS

Advertising Control
n Generally, prohibition of advertisement before product is
approved and cleared to enter market
n Prohibition of any misleading or fraudulent advertisement
n Must comply with legal requirements on product
advertisements with medical claims
Post Market Control
n Vendor after-sale obligations
n Problem reporting
n Implant registration
n Distribution records
n Recall procedure
n Complaint handling

28
Lecture on Medical Device Regulation
 Product life span of a medical device
n CONCEPTION AND DEVELOPMENT (Manufacturer)
n MANUFACTURE (Manufacturer)
n PACKAGING AND LABELLING (Manufacturer)

n ADVERTISING (Vendor)
n SALE (Vendor)

n USE (User)
n DISPOSAL (User)

29
Lecture on Medical Device Regulation
 STAKE-HOLDERS RELATIONSHIP

Manu-
facturer
Govern
Vendor
STAKEHOLDERS -ment
RELATIONSHIP FOR SHARED
RESPONSIBILITY
ENSURING THE COMMUNICATION
SAFETY AND PARTICIPATION
EDUCATION
PERFORMANCE OF RISK/COST
ASSESSMENT
MEDICAL DEVICES
User Public

Patient

30
Lecture on Medical Device Regulation
 The Manufacturer
n Creator of the medical device
n Manufactures product to comply design standards
n Establishes the intended use
n Devises product quality, safety, efficacy and cost
The Vendor
n Facilitates product to user; presents IFY and PI
n Ensures compliance to government regulations
n Maintains safety and performance
n Handles PMS and Customer complaints
n SOP or COP
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Lecture on Medical Device Regulation
 The User
n Avoid user error
n Qualification and training to use, IFU and PI
The Public
n Awareness for safety and performance
n Information education and market pressure
The Government
n Oversees efforts of manufacturers and vendors
n Establishes policy and regulations

32
Lecture on Medical Device Regulation
 IMPLEMENTATION OF REGULATION

1. Pre-market
n Product control, application for licensing or listing
n Product submitted for technical review

Country NCA Control Mechanism / Tools

Australia TGA ARTG Number
Canada HC Device license
Europe EU CE Mark
Japan MHLW Approval notification
USA FDA Approval Letter / notice
Hong Kong MDCO Listing certificate

33
Lecture on Medical Device Regulation
 IMPLEMENTATION OF REGULATION

2. On-Market
n Presentation by vendor to user / public education
n Labeling and advertisement control

Country NCA Control Mechanism / Tools

Australia TGA Enterprise Identification ENTID
Canada HC Establishment license
Europe EU Registered Person or QP
Japan MHLW Manufacturer or Import License
USA FDA Establishment Registration
Hong Kong MDCO Manufacturer or Importer Regn

34
Lecture on Medical Device Regulation
 IMPLEMENTATION OF REGULATION

3. Post-Market
n Product in use continues to be safe and effective
n Maintain system of PMS and vigilance
n Problem reporting
n Implant registration
n Distribution record
n Recall procedure
n Complaint handling

35
Lecture on Medical Device Regulation
 IMPLEMENTATION OF REGULATION

4. Quality System
NCA QMS Responsible Party
TGA ISO 13485 Government and third
party
HC ISO 13485 Third party
EU ISO 13485 (EN46001) Third party
MHLW GMP #40 ordinance Government
Government
GMPI #63 ordinance
QS Standard for medical
devices #1128 notice
FDA QS (21 CFR part 820) Government
MDCO ISO 13485 Third party
** MDCO is renamed as MDD as of 1 Oct 2019
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Lecture on Medical Device Regulation
 WHO GREENISH YELLOW BOOK

The Rise of IVD MD

n 2017 WHO Publication
n Global Model regulatory
framework for MD including
IVD MD

37
Lecture on Medical Device Regulation
 Definition, classification, essential principles and
conformity assessment of medical devices
n 1 Definition of medical device and IVD
n 2 MD classification and classification rules
n 3 Essential principles of safety and performance
§ Clinical evidence for non-IVDs
§ Assessing conformity to the Essential Principles (EP)

38
Lecture on Medical Device Regulation
 Special considerations for regulation of IVDs
n 1 Classification of IVDs
n 2 Essential Principles of safety and
performance for IVDs
n 3 Clinical evidence for IVDs
n 4 Lot verification testing of IVDs

39
Lecture on Medical Device Regulation
 Enabling for effective regulation of medical devices
n 1 Legal requirements
n 2 Gap analysis of existing controls
n 3 Implementation plan
n 4 Monitoring implementation
n 5 Regulatory authority
n 6 Funding the regulatory system
n 7 Conflict of interest and impartiality
n 8 Regulatory competencies and resources
40
Lecture on Medical Device Regulation
 THE FIRST STEPS

n 1. Publish law, including definition, and

regulations, implementation plan with
transition period
n 2. Establish medical device classification
for regulatory purposes
n 3. Establish Essential Principles of safety
and performance

41
Lecture on Medical Device Regulation
 Basic and Expanded Regulatory Controls

Basic regulatory controls

n Scope of control system
n Classification and declaration
n Quality System Requirement
n Labelling and Identification

Expanded Regulatory Controls

n Efficacy and Clinical Performance
n Compliance to Recognized International Standards
n EP (Essential Principles of Safety & Performance

42
Lecture on Medical Device Regulation
 PREMARKET –
BASIC-LEVEL CONTROLS

n 1 Establish a basis for reliance and recognition

n 2 Establish requirements for declaration of
conformity
n 3 Establish requirement for manufacturers to have
a QMS
n 4 Establish requirements for labels and labelling
n 5 Prohibit deceptive, misleading and false
advertising
n 6 Establish provisions for exceptional premarket
situations
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Lecture on Medical Device Regulation
 PREMARKET –
EXPANDED CONTROLS

n 1 Create oversight of clinical investigations

n 2 Appoint and have oversight of CAB
n 3 Recognition of standards
n 4 Adopt a medical device nomenclature
system
n 5 Control advertising and promotion

44
Lecture on Medical Device Regulation
 PLACING ON MARKET –
BASIC-LEVEL CONTROLS

n 1 Registration of establishments
n 2 Listing of medical devices
n 3 Import controls

45
Lecture on Medical Device Regulation
 PLACING ON MARKET –
EXPANDED CONTROLS

n 1 Perform in-country QMS audits

n 2 Perform review of submissions for
compliance with Essential Principles

46
Lecture on Medical Device Regulation
 POSTMARKET – BASIC CONTROLS

n 1 Establish a system for vigilance reporting

n 2 Require mandatory notification by the
manufacturer of FSCA
n 3 Establish a procedure to withdraw unsafe medical
devices from the market
n 4 Establish procedure to issue safety alerts to users
n 5 Undertake market surveillance

47
Lecture on Medical Device Regulation
 POSTMARKET – EXPANDED CONTROLS

n 1 Establish within the regulatory authority

processes for postmarket surveillance and vigilance
n 2 Require mandatory reporting of adverse events
n 3 Inspections of registered establishments
n 4 Provide for testing laboratories

48
Lecture on Medical Device Regulation
 ADDITIONAL REMARKS

n 1 Establish whether a medical product is an MD

n 2 Disposal
n 3 Donations
n 4 Reprocessing of single-use medical devices
n 5 Refurbishing electromedical devices
n 6 Substandard and falsified products
n 7 WHO Prequalification Team for IVDs;
n 8 United Nations Population Fund Prequalification
Programme for intrauterine devices and condoms
Stepwise approach, harmonization, reliance, recognition

49
Lecture on Medical Device Regulation
An International Model of
Medical Device Regulatory
Framework
 CONTROL MECHANISMS

51
Lecture on Medical Device Regulation
 THE ROLE OF THE GOVERNMENT REGARDING
MEDICAL DEVICE REGULATION

n The critical elements of the life span of medical

devices that require regulatory attention are
highlighted. (Pre-market, On-market and Post-
market)
n A common regulatory framework is proposed
integrating the regulatory systems with the most
advanced medical device regulations, along with
the applicable regulatory tools.

52
Lecture on Medical Device Regulation
 Governmental regulation of medical devices
n 1 Critical elements for regulatory attention
n 2 Stages of regulatory control
n 3 A common framework for medical device regulations
n 4 Regulatory tools and general requirements
4.1 Product control
4.2 Vendor establishment control
4.3 Post-market surveillance/vigilance
4.4 Quality system requirements

53
Lecture on Medical Device Regulation
 Regulatory
Controls
and
Reasons
Behind

54
Lecture on Medical Device Regulation
 REGULATORY CONTROLS OVER PRODUCT
LIFE SPAN OF A MEDICAL DEVICE

n CONCEPTION AND DEVELOPMENT (Pre-market)

n MANUFACTURE (Pre-market)
n PACKAGING AND LABELLING (Pre-market)

n ADVERTISING (Placing on market)

n SALE (Placing on market)

n USE (Post-market Surveillance/ Vigilance)

n DISPOSAL (Post-market Surveillance/ Vigilance)

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Lecture on Medical Device Regulation
 THE STAGES OF MD REGULATORY
CONTROL - PURPOSES

n Pre-market control is performed on the device to

ensure that the product to be placed on market
complies with regulatory requirements. Labelling
and advertising control is maintained for correct
product representation.
n Placing-on-market control ensures establishment
registration, device listing and after-sale obligations.
n Post-market surveillance/vigilance ensures the
continued safety and performance of devices in
use.

56
Lecture on Medical Device Regulation
 PRE-MARKET

57
Lecture on Medical Device Regulation
 ON-MARKET

58
Lecture on Medical Device Regulation
 Post market

59
Lecture on Medical Device Regulation
 A COMMON FRAMEWORK FOR MEDICAL
DEVICE REGULATIONS

STAGE PRE-MARKET PLACING ON-MARKET POST-MARKET

CONTROL/ Product Sale After-sale/ use

MONITOR
PERSON Manufacturer Vendor Vendor/ user
Device attributes Establishment registration
Items or • Safety and • List products available or in
Surveillance/vigilance
activities performance use
regulated • Requires vendor to fulfill • After-sale obligations
Manufacturing after-sale obligations • Monitoring of device’s
•Quality systems clinical performance
Advertising (representation)
•Prohibits misleading or • Problem identification
Labelling fraudulent advertisement and alerts
• Accurate description of
product
• Instructions for use

60
Lecture on Medical Device Regulation
 REGULATORY TOOLS

Quality Control
n Quality System Requirements (QSR)
n ISO 13485
n GMP
n QS standard (21 CFR part 820 for US FDA)

61
Lecture on Medical Device Regulation
 Medical Device
Regulation Harmonization

(REFER TO SUB-MODULE
ON Regulation Harmonization)

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Lecture on Medical Device Regulation
 INTERNATIONAL EFFORTS ON
REGULATION HARMONIZATION

n GHTF
n PAHO and LAHWP
n ALADDIV
n AHWP
n PAHWP
n IMDRF
n ASEAN

(Refer to sub-module on Regulation Harmonization)

63
Lecture on Medical Device Regulation
 BENEFITS OF HARMONIZATION

n The work of the Global Harmonization Task Force (GHTF),

whose mission is to harmonize the implementation of
medical device regulations across the globe.
n The objectives of its five Study Groups relate to the
Medical Device Life Span Diagram.
n Facilitate ease of reference for countries wishing to adopt
final GHTF documents as they relate to the common
regulatory framework.
n In 2012, GHTF has been replaced by the International MD
Regulatory Forum (IMDRF) which has a more authoritative
role in the implementation of medical device regulation.

64
Lecture on Medical Device Regulation
 Goal for Regulation Harmonization

n The objective would be to

establish a common system that
might compromise majority of
interests and concern for most
communities and countries in the
world.

65
Lecture on Medical Device Regulation
 THE IDEAL MD REGULATION MODEL

Two actions are proposed that could be undertaken at the international

level to address priority needs for product control and their safe and
effective use:
n i) The establishment of a uniform certification format that will be used
globally so that different countries can certify that medical devices being
exported comply with their domestic regulatory requirements. This
certification will help the importing countries to regulate medical devices.
n ii) Support for a centre to coordinate and relay medical device problems,
recalls, and alerts to the global community. This will enhance the safety
and performance of medical devices in use around the world.

66
Lecture on Medical Device Regulation
 ESSENTIAL FEATURES

n Adoption of a clear legal definition of the term “medical device”

in order to distinguish this commodity from others that are
subject to regulation e.g. pharmaceuticals.
n The Global Harmonization Task Force proposed harmonized
definition for medical devices (see GHTF document
SG1/N029R11) is adopted

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Lecture on Medical Device Regulation
 ESSENTIAL FEATURES

Two basic categories apply to importer countries as well as

those with native medical device industries.
n Establishment of a procedure for identifying manufacturers
with business operations in the country for which the
regulatory program is being devised, as well as for
imported and domestically-produced products distributed
within national borders.
n Initiation of a system to maintain vigilance over marketed
products to ensure their continued safety and quality, as
well as ongoing regulatory compliance by manufacturers
after obtaining market clearance. A method for information
sharing among users and national health authorities of
similar devices is vital to preventing additional adverse
incidents and their unwanted health effects.

68
Lecture on Medical Device Regulation
 ESSENTIAL FEATURES

Two other basic categories apply chiefly to countries with

domestic producers of medical devices.
n Implementation of a board-based regularized program of
manufacturing site inspections and audits allow verification
of corporate conformance with clearly-defined
manufacturing standards and methods for validating
quality assurance in commercial production of devices.
n Construction of a regulatory system that is risk-based, that
is, a system that stratifies and applies premarket controls
based on risk potential of a product, as well as the
potential for misuse and the breadth of commercial
distribution, known or projected.

69
Lecture on Medical Device Regulation
70