updates on medical device regulatory requirement … · 2018-02-12 · pihak berkuasa peranti...

Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA

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UPDATES ON MEDICAL DEVICE REGULATORY REQUIREMENT AND

HARMONISATION OF MEDICAL DEVICES REGULATORY REQUIREMENTS IN THE

ASEAN REGION -

IR.SASIKALA DEVI MEDICAL DEVICE AUTHORITY

MINISTRY OF HEALTH MALAYSIA

MEDICAL DEVICES AUTHORITY, Ministry of Health Malaysia Level 5, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya,MALAYSIA

http://www.mdb.gov.my ● [email protected]


CONTENT

• UPDATES ON MEDICAL DEVICES REGULATORY SYSTEM

• BACKGROUND AMDD

• HARMONISATION OF MD REGULATORY REQUIREMENTS

• INTRODUCTION TO AMDD

• AMDD ARTICLES

• UPDATES ON AMDD

MEDICAL DEVICES REGULATION: REGULATORY FRAMEWORK IN MALAYSIA:

Stages of Regulatory Control throughout the life cycle of medical device

WHO Regulatory Model

MEDICAL DEVICES AUTHORITY MALAYSIA . http://www.mdb.gov.my

http://www.mdb.gov.my/

TIMELINE

14 June 2012 : Establishment of Medical Device Authority

30 June 2013 : Effective date of Act 737

1 July 2013 : Effective date of MDR 2012

1 July 2013 : 1 July 2014 : Transitional period for Licensing of Establishment

I July 2013- 1 July 2015 : Transitional Period for Registration of Medical Devices

MANDATORY

REGISTRATION OF

MEDICAL DEVICES

1 JULY 2015

…extended to

1 JULY 2016

Market Access and Control

Medical Device Product Control Facilitate

trade and Industry

Ensure public

health and safety

Establish. Control

Export Permit List of

Products

Int. Standards

List of Licensed Est

Harmonised Regulations

Permit Of DMD

Usage

Maint. Disposal

Product Registration

C

D

B

A

CAB

Regist Manuf.

Dist. Importer

AR

Establish. License

Advertisement QMS

Product

POST-MARKET VIGILANCE AND SURVEILLANCE SYSTEMS & ENFORCEMENT

Medical Device Act 2012 (Act 737) Objective and control

List of Registered Conformity Assessment Body (16-CAB)

http://www.mdb.gov.my/mdb/index2.php?option=com_docman&task=doc_view&gid=216&Itemid=59














REGISTERED CAB_SKOP&PERSONEL Rev13.pdf

REGISTERED CAB_SKOP&PERSONEL Rev13 (1).docx

REGISTERED CAB_SKOP&PERSONEL Rev13.pdf

REGISTRATION Medical Device

GM& IVD

NUMBER OF APPLICATION RECEIVED 23,567

TOTAL NUMBER OF MEDICAL DEVICE UNDER

EVALUATION 427,043

TOTAL NUMBER OF MEDICAL DEVICES APPROVED FOR

REGISTRATION (Include Class A) 50,728

ESTABLISHMENT LICENSE NO

APPLICATION SUBMITTED 2470

APPROVED 1663

POLICY DETAILS

2014 1 / 2014 - Establishment As Authorised Representative And

Establishment Undertaking Multiple Activities

2 / 2014 - Conformity Assessment Procedures For Medical

Device Approved By Recognised Countries

3 / 2014 - Exemption Of Medical Device From Registration

Requirements

Note:The Circular Letter will no longer effective. Please Refer

to Medical Device Exemption 2016

4 / 2014 - Medical Device For The Purpose Of Export And Transit And

Medical Device For Import/Export From/To Countries Without

Diplomatic Ties With Malaysia

5 / 2014 - Certification Of Good Manufacturing Practice (GMP)

For The Purpose Of Obtaining Establishment License

http://www.mdb.gov.my/mdb/index.php?option=com_content&task=view&id=283

YEAR DETAILS

POLICY STATUS

2015 Advertisement of Medical Device During Transition Period Beyond Jurisdiction of

Act 737

Gazettement Of Non-Corrective Contact Lens As A Medical

Device Draft ORDER

Post Market Responsibility For Local Manufacturer / AR Who

Has Closed Their Business

Beyond Jurisdiction of

Act 737

Requirement For Registration Of Orphaned Medical Device In

Hospital Or Institutional Healthcare Facilities

Beyond Jurisdiction of

Act 737

Issuance Of Certificate Of Free Sale (CFS)/

Manufacturing Certificate (MC) Completed

Fast Track Medical Device Registration During Transition Period Dropped

2016 1 / 2016 - Refurbishment of Medical Device

2 / 2016 - Medical Device Procurement For Healthcare Institution

3 / 2016 - Change Of Ownership For Medical Device Registration

4 / 2016 - Transition Period For Medical Device Labeling

5 / 2016 - Imposition Of Charges Or Fees For Product Classification

REGULATORY &

GUIDANCE

DOCUMENTS

DETAILS

2014 1. Product Grouping First Edition October 2013

2. IVD Medical Device Classification System First Edition July 2013

3. Essential Principles of Safety & Performance of IVD Medical Device, First Edition

July 2013

4.Principles Of Conformity Assessment For In- Vitro Diagnostic (IVD) Medical

Devices First Edition July 2013

5.Common Submission Dossier Template of IVD Medical Device First Edition July

2013

6.Definition of Medical Device, First Edition March 2014

7.Essential Principles of Safety & Performance of Medical Device, First Edition March

2014

8.Common Submission Dossier Template, First Edition March 2014

9. The rules of classification for general medical devices, First Edition March 2014

2015 Good Distribution Practice for Medical Devices (GDPMD), First Revision

November 2015

2016 1. Good Refurbishment Practice of Medical Devices (GRPMD) First edition 2016

2. Guidance Document Declaration of Conformity First Edition February 2016

3. Guidance Document On Licensing for Establishment

4. Guidance Document On Requirements For Labelling Of Medical Devices

CFS NO CERTIFICATES

2008-2015 10823

NUMBER OF CERTIFICATES (AS OF JULY 2016) 713

CONSULTATION SESSION` NO ESTABLISHMENT

2013-2015 534

2016 71

AWARENESS PROGRAM NO PROGRAMS

AWARENESS PROGRAMME ON 2013-2015 21

AWARENESS PROGRAMME ON 2016

16

AWARENESS PROGRAM 2015

USER:6 ZONE

JOHOR,PERLIS,

PERAK,PUTRAJAYA,

SHAH ALAM,SABAH&

SARAWAK

INDUSTRY: 10

JOHOR,PENANG,

PUTRAJAYA, KL,

MELAKA, AWARENESS PROGRAME

2016


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BACKGROUND ON AMDD


ASSOCIATION OF SOUTHEAST ASIAN NATIONS(ASEAN)

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ASEAN

ASEAN is a geo political and economic organization of ten countries located in Southeast Asia which was formed on 1967

10 MEMBER STATES: Malaysia,

Philippines,

Thailand,

Indonesia,

Singapore,

Vietnam,

Brunei

Darussalam,

Lao PDR,

Cambodia,

Singapore


ASEAN FREE TRADE AREA (AFTA)

• In 1992, ASEAN Heads of Government declared that ASEAN Free Trade Area (AFTA) shall

be established in the region and in 1995, agreed to accelerate its implementation to the

year 2003.

• ASEAN Economic Consultative Committee,

• ASEAN Social Consultative Committee &

• ASEAN Consultative Committee on Standards and Quality (ACCSQ)

• ASEAN Consultative Committee for Standards and Quality (ACCSQ) was formed by the ASEAN Economic Minister in 1992.

− Aim of ACCSQ is to remove technical barriers to trades in order to facilitate and realize the ASEAN Free Trade Area (AFTA).

− Focus:

harmonisation of standards- technical requirements

development of MRA on conformity assessment and

development of harmonised regulatory regime

• The establishment of the ASEAN Economic Community has been accelerated from 2020

to 2015 which will create ASEAN as a single market and production base.

ASEAN HARMONIZATION

The Activities of ACCSQ is Formalizing Harmonization between all ASEAN members countries with developing technical, standard and legal aspect to implementation the harmonization of regulation


PRODUCT WORKING GROUP ON MEDICAL DEVICE (ACCSQ-MDPWG)

• Product Working Group on Medical Device (ACCSQ-MDPWG) was established to fast- track

integration of the medical device within ASEAN Member Economies, 2005.

• Objectives: to implement measures to facilitate the integration of medical device within

ASEAN Member Economies.

• Role and responsibilities of MDPWG

Developing a CSDT template for product approval in ASEAN

Exploring the feasibility of an abridged approval process for medical devices of approved or

benchmarked countries

Exploring the feasibility of adopting a harmonized system of placement of medical devices into

the ASEAN markets, based on a common product approval process

Formalizing of a post-marketing alert system for defective or unsafe medical devices.

Exchange of information on standards, regulations, procedures and mandatory

requirements in Member Countries related to medical devices;

Review and analyze the comparative study of regulatory regimes among Member Countries;

Identify the technical infrastructure needs and build-up mutual confidence in testing and

conformity assessment

• ASEAN MEDICAL DEVICE DIRECTIVE (AMDD) was signed on 21 November 2014

• In 2015 establishment of ASEAN Medical Devices Committee (AMDC)

Goal of creating an ASEAN Economic Community by 2015, with fast-

track integration of the 12 priority sectors

1. Agro-base product 5. Electrical 9. Health care product

( drug, traditional drug,

cosmetic and Medical

Devices)

2. Air Travel 6. Rubber base

product

10. Textiles and

apparels

3. Automotive 7. Tourism 11. Wood-based product

4. e-ASEAN 8. Fisheries 12. Logistics Services

ASEAN Economic Consultative Committee

ASEAN Social Consultative Committee

ASEAN Consultative Committee on Standards and Quality (ACCSQ)

HARMONIZATION OF

MEDICAL DEVICES

REGULATION in ASEAN


HARMONIZATION OF MEDICAL DEVICES REGULATION

GROUP OF HARMONIZATION

IMDRF (GLOBAL)

AHWP (ASIA)

ACCSQ (ASEAN)

Voluntary Voluntary

Mandatory

MDPWG WORK PROGRAMME

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ACSDT CAPACITY

BUILDING

GHTF Recommendations

NOMENCLATURE for

medical devices

AMDD …..signed 2014

POST

MARKETING

ALERT SYSTEM..

To facilitate the integration of the medical devices sector through

elimination of technical barriers to trade in ASEAN

HARMONIZATION IN AMDD

Definition of medical device

Risk based classification

Standards -a similar level of quality assurance

(major features)

CSDT

EPSP

PMAS

Registration of product

Licencing of establishment

QMS ISO13485/ISO14971

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INTRODUCTION TO ASEAN MEDICAL DEVICE DIRECTIVE

(AMDD)




WHAT IS AMDD?

The AMDD is a legal and institutional framework for

the ASEAN Community to harmonise medical devices

regulation in the region. It is a common medical

device directive in ASEAN among Member States

(MS)

A key objective of the AMDD is to ensure only safe,

effective and quality medical devices are placed in

the ASEAN region.

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• The primary goal is to protect public health and safety

• The level of regulatory control should be proportional to the degree of risk

• Expedites timely availability and access to safe and beneficial medical

devices and to prevent unsafe and ineffective medical devices from

entering the market

• Elements of control from design, manufacture and placement in the

market shall be put in place to ensure continued safety and quality

• In-line with global harmonization effort to minimize regulatory barriers,

facilitate international trade, improve access to new technologies and to

reduce the cost of implementing regulation

AMDD Guiding Principles

AMDD STRUCTURE

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National Laws of Member States for Medical

Device Control

Transpose AMDD into National Laws

ARTICLE1

ARTICLE2

ARTICLE3

ARTICLE5

ARTICLE4

ANNEX1 ANNEX2 ANNEX3 ANNEX4 ANNEX5 ANNEX6 ANNEX7 ANNEX8

ARTICLE6

ARTICLE7

ARTICLE8

ARTICLE9

ARTICLE10

ARTICLE11

ARTICLE12

ARTICLE13

ARTICLE14-24

AMDD

ARTICLE

PROVISION

ARTICLE1 GENERAL PROVISION

ARTICLE 2 DEFINITION AND SCOPE

ARTICLE 3 ESSENTIAL PRINCIPLES OF SAFETY AND

PERFORMANCE OF MEDICAL DEVICE

ARTICLE 4 CLASSIFICATION OF MEDICAL DEVICES

ARTICLE 5 CONFORMITY ASSESSMENT OF MEDICAL DEVICE

ARTICLE 6 REGISTRATION AND PLACEMENT ON THE MARKET

ARTICLE 7 LICENSING OF PERSON RESPONSIBLE FOR PLACING

MEDICAL DEVICES ON THE MARKETS OF MEMBER

STATES

ARTICLE 8 TECHNICAL DOCUMENTS FOR MEDICAL DEVICES

ARTICLE 9 REFERENCE TO TECHNICAL STANDARDS

ARTICLE 10 LABELLING

ARTICLE 11 MEDICAL DEVICES CLAIMS

ARTICLE 12 POST-MARKETING ALERT SYSTEM

ARTICLE 13 CLINICAL INVESTIGATION 28

AMDD

ARTICLES

AMDD PROVISION

ARTICLE 14 INSTITUTIONAL ARRANGMENTS

ARTICLE 15 SAFEGUARD CLAUSES

ARTICLE 16 CONFIDENTIALITY

ARTICLE 17 SPECIAL CASES

ARTICLE 18 IMPLEMENTATION

ARTICLE 19 REVISIONS, MODIFICATIONS AND

AMENDMENTS

ARTICLE 20 DISPUTE SETTLEMENT

ARTICLE 21 RESERVATIONS

ARTICLE 22 ENTRY INTO FORCE

ARTICLE 23 ANNEXES

ARTICLE 24 DEPOSITARY

AMDD ANNEXES

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ANNEX CONTENTS

ANNEX1 ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL

DEVICES

ANNEX 2 Risk Classification Rules for Medical Devices other than IVD Medical

Devices

ANNEX 3 Risk Classification Rules for IVD Medical Devices

ANNEX 4 ASEAN Common Submission Dossier Template

ANNEX 5 Post Marketing Alert System (PMAS) Requirements

ANNEX 6 Components Elements of a Product Owner’s or Physical Manufacturer’s

Declaration of Conformity (DOC)

ANNEX 7 Labelling Requirements

ANNEX 8 Clinical Investigation

AMDD

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ARTICLE PROVISION CONTENTS

ARTICLE1 GENERAL PROVISION

Only medical devices which conform to the provisions

of this ASEAN Agreement on Medical Device Directive

and its Annexes may be placed on the markets of

that Member State

Medical device shall be registered with the

Regulatory Authority of that Member State.

The person responsible for placing the medical

device in that Member State or the authorised

representative shall be licensed.

ARTICLE 2 DEFINITION AND SCOPE “authorised representative” means any person in

a Member State who, explicitly designated by the

product owner, acts and may be addressed by

authorities and bodies in a Member State instead

of the product owner with regard to the latter’s

obligations under this Agreement, and relevant

laws and regulations of the Member State.

“authorised distributor”, in relation to the placing

on the market of a medical device, means any

person who has been authorised by the product

owner or authorised representative to distribute

the medical device in that Member State.

“manufacture”, in relation to a medical device,

means to make, fabricate, produce or process the

medical device and includes:

any process carried out in the course of so

making, fabricating, producing or processing the

medical device; and/or the packaging and

labelling of the medical device before it is

supplied.

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ARTICLE 3 ESSENTIAL PRINCIPLES OF

SAFETY AND PERFORMANCE

OF MEDICAL DEVICE

Medical devices shall meet the essential

principles set out in Annex 1

ANNEX 1: ESSENTIAL PRINCIPLES OF SAFETY AND

PERFORMANCE OF MEDICAL DEVICES

ARTICLE 4 CLASSIFICATION OF

MEDICAL DEVICES

Medical devices shall be classified into the

following four classes, in accordance with risk

classification rules set out in Annex 2 (Risk

Classification Rules for Medical Devices other

than IVD Devices) and Annex 3 (Risk Classification

Rules for IVD Devices):

Class Risk Level

A Low risk

B Low-moderate risk

C Moderate-high risk

D High risk

ANNEX 2 ;RISK CLASSIFICATION RULES

FORMEDICAL DEVICES OTHER THAN IVD MEDICAL

DEVICES

ANNEX 3; 3RISK CLASSIFICATION RULES FOR IVD

MEDICAL DEVICES

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ARTICLE 5 CONFORMITY ASSESSMENT OF

MEDICAL DEVICE

Assessed by the Regulatory Authority of that Member

State, or any appointed bodies recognised by that

Member State, for conformity and compliance unless

the medical device has been exempted

ARTICLE 6 REGISTRATION AND

PLACEMENT ON THE MARKET

A medical device which has been assessed by the

Regulatory Authority of that Member State or any

appointed bodies recognised by that Member State to

be in conformity and in compliance with the

requirements laid down in this Agreement may be

placed on the market of that Member State.

A medical device to be placed on the market of a

Member State shall be registered with the Regulatory

Authority of that Member State. The Regulatory Authority

of the Member State may exempt certain medical

devices from the requirement for registration where

appropriate.

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ARTICLE 7 LICENSING OF PERSON

RESPONSIBLE FOR PLACING

MEDICAL DEVICES ON THE

MARKETS OF MEMBER STATES

Each Member State shall require a person who is

responsible for placing medical devices on the market to

be licensed by the Regulatory Authority of that Member

State before the medical devices are placed on the

market of that Member State.

ARTICLE 8 TECHNICAL DOCUMENTS FOR

MEDICAL DEVICES

ANNEX 4 ASEAN COMMON SUBMISSION DOSSIER

TEMPLATE

ANNEX5;POST MARKETING ALERT SYSTEM (PMAS)

REQUIREMENTS

ANNEX 6:COMPONENTS ELEMENTS OF A PRODUCT

OWNER’S OR PHYSICAL MANUFACTURER’S

DECLARATION OF CONFORMITY (DOC)

ARTICLE 9 REFERENCE TO TECHNICAL

STANDARDS

Technical standards recognised by the AMDC or other

technical standards accepted by the Regulatory

Authority of a Member State

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ARTICLE PROVISION ANNEX

ARTICLE 10 LABELLING ANNEX 7: LABELLING REQUIREMENTS

ARTICLE 11 MEDICAL DEVICES CLAIMS Claimed benefits of a medical device shall be justified by

substantial evidence in accordance with the

requirements as set out in Annex 1

ANNEX 1: ESSENTIAL PRINCIPLES OF SAFETY AND

PERFORMANCE OF MEDICAL

ARTICLE 12 POST-MARKETING ALERT

SYSTEM

Each Member State shall require

• keep all relevant records

• inform the Regulatory Authority, any adverse

• inform the Regulatory Authority, to perform

FSCA.

AMDD STRUCTURE

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ARTICLE PROVISION ANNEX

ARTICLE 13 CLINICAL

INVESTIGATION

Member States shall put in place an appropriate system for the

conduct of clinical investigation of medical devices.

The product owner, or his authorised representative, or the sponsor of

the clinical investigation in a Member State, register with the

Regulatory Authority of that Member State in which the investigations

are to be conducted.

Where a clinical investigation is refused or halted , inform all Member

States and the AMDC.

Where a Member State has called for a significant modification or

temporary interruption of a clinical investigation, that Member State

may inform all Member States and the AMDC concerned about its

actions and the grounds for the actions taken.

Notify of the end of the clinical investigation

In the case of early termination of the clinical investigation on safety

grounds, this notification may be communicated to the Regulatory

Authority of all Member States where the clinical investigation is

carried out.

ANNEX 8:CLINICAL INVESTIGATION

AMDD CONT…

36

AMDD

ARTICLES

AMDD PROVISION ANNEX

ARTICLE 14 INSTITUTIONAL ARRANGMENTS (1) The AMDC shall be established with the

overall responsibility of coordinating,

reviewing and monitoring the

implementation of this Agreement and shall

comprise representatives from the

Regulatory Authority of each Member State.

(2) The AMDC may establish an ASEAN Medical

Device Technical Committee (AMDTC) to

assist the AMDC in reviewing the technical

and safety issues.

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AMDD

ARTICLES


ARTICLE 15 SAFEGUARD CLAUSES Acknowledgment by each Member State

that a medical device placed on its

market shall not compromise health or

safety of patients

Member State shall immediately inform

other Member State of measures taken, it

shall take all appropriate interim

measures to withdraw such medical

device from the market or prohibit or

restrict their being placed on the market

or put into service

- Failure to conform to EPSP

- Incorrect application of Technical

Standards

- Shortcomings in the Technical

Standards

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AMDD

ARTICLES


ARTICLE 16 CONFIDENTIALITY Without prejudice to the existing national laws

and regulations, Member States shall require

that all the parties involved in the application

of this Agreement are bound to observe

confidentiality with regard to all confidential

information obtained in carrying out their tasks

ARTICLE 17 SPECIAL CASES Flexibility given to Member States for reason of

religious and cultural difference

Acknowledged by ASEAN to strictly observe the

provisions

39

AMDD

ARTICLES


ARTICLE 18 IMPLEMENTATION Member States shall undertake appropriate

measures to implement this Agreement

ARTICLE 19 REVISIONS, MODIFICATIONS

AND AMENDMENTS

(1) The provisions of all or any part of this

Agreement may be revised, modified or

amended, by written agreement of all Member

States.

ARTICLE 20 DISPUTE SETTLEMENT The ASEAN Protocol on Enhanced Dispute

Settlement Mechanism signed on 29 November

2004 in Vientiane, Lao PDR and amendments

thereto, shall apply to the settlement of disputes

concerning the interpretation or implementation

of this Agreement

ARTICLE 21 RESERVATIONS Member States shall make no reservation with

respect to any of the provisions of this

Agreement.

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AMDD

ARTICLES


ARTICLE 22 ENTRY INTO FORCE This Agreement shall be subject to

ratification and/or acceptance by

Member States in accordance with their

internal domestic requirements.

This Agreement shall enter into force on 1

January 2015 and shall be in force only

among the Member States that have

ratified and/or accepted it.

ARTICLE 23 ANNEXES The Annexes to this Agreement constitute an

integral part of this Agreement.

ARTICLE 24 DEPOSITARY This Agreement shall be deposited with the

Secretary- General of ASEAN, who shall

promptly furnish each Member State a

certified copy thereof.


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UPDATES ON

AMDD CURRENT TRANSPOSITION STATUS

IN MEMBER COUNTRIES



Member States

Status

Brunei Darussalam

Ratification process expected to be completed by 2017

Cambodia Still in the process of ratification, expected to be ready by 2017.

Indonesia Still in the domestic process for ratification; The ratification of AMDD is targeted by 1st quarter of 2017;

Lao PDR AMDD has been ratified on 25 May 2015;

Malaysia Ratification of AMDD is expected by mid-2017.

Philippines

Ratification of AMDD is expected to be submitted by 2016.

Singapore

Instrument of ratification has been submitted to the ASEAN Secretariat on 10 November 2015;Ready to fully implement AMDD.

Thailand

Ratification of AMDD is expected to be submitted 2017.

Viet Nam

Viet Nam has submitted the Instrument of Acceptance of AMDD to the ASEAN Secretariat on 21 March 2016.

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PROGRESS OF MDPWG TO AMDC

• Establishment of the ASEAN Medical Device Committee (AMDC)

• To coordinate,review and monitor the implementation of AMDD

• Comprise of representatives from Regulatory Authority of each Member

State

• The ACCSQ and ASEAN Secretariat shall support in coordinating and

monitoring the implementation of AMDD

• AMDC may establish ASEAN Medical Device Technical Committee (AMDTC)

to assist the AMDC in reviewing the technical safety and safety issues.

• Milestone for completion of transposition process and submission of

instrument of ratification by 2020. The milestone will include, among

others, the following items

(i) Development of Guidelines for implementation of AMDD,

(ii) Implementation of AMDD in phases,

(iii) Monitoring of the implementation of AMDD

(iv) Development of a matrix on common interpretation of AMDD


AMDC

GOAL 1

Harmonization of

Medical Device

Regulations in

ASEAN

GOAL 2 :

Implementation of

Program to improve

technical

infrastructure and

capacity building

GOAL 3 :

Co-operation/

collaboration with

international/

regional organization


General Principles

Medical device should be designed & manufactured in such a way that:

1. no compromise to clinical condition or safety of patients, or safety and health of users or other persons

2. control the risk so that residual risk is brought down to an acceptable level

3. Shall achieve the performance intended and designed , manufactured and packaged in such a way that they are suitable for one or more of the functions within the scope of the definition of a medical device

4. characteristics and performances in clause1,2 and 3 shall not be adversely affected to such a degree that they compromise the health or safety of patient or user and other persons during the lifetime of the device

5. characteristics and performances during their intended use will not be adversely affected under transport and storage conditions

6. benefits must be determined to outweigh any undesirable side effects

7. shall require clinical evidence, demonstrate it complies with epsp

Design and Manufacturing Principles

1. Chemical, physical and biological properties of the material used to minimise risk

2. Infection and microbial contamination eliminate or reduce as far as reasonably practicable and appropriate the risk of infection to any person

3. Manufacturing and environmental properties to remove or reduce as far as reasonably practicable the risk

4. Devices with a diagnostic or measuring function sufficient accuracy , precision and stability

5. Protection against radiation , exposure reduced as far as reasonably practicable and appropriate compatible with the intended purpose

6. Requirements for medical devices connected to or equipped with an energy source, ensure repeatability . reliability and performance according to intended purpose

7. Protection against mechanical risks

8. Protection against the risks posed to the patient by supplied energy or substances

9. Active implantable medical devices shall incorporate identification code

10. Protection against the risks posed to the patient for devices for self-testing or self- administration

11. Information supplied by manufacturer; identify device, product owner, how to use device

12. Clinical investigation

Essential Principles of Safety & Performance of Medical Device

updates on medical device regulatory requirement … · 2018-02-12 · pihak berkuasa peranti...

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