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IN-VITRO DIAGNOSTIC DEVICE


 

What is a medical device?

According to Section 2 of Act 737, “medical device” means 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 purpose (s) of;

  • diagnosis, prevention, monitoring, treatment or alleviation of disease;
  • diagnosis, monitoring, treatment, alleviation of or 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

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; and

b. any instrument, apparatus, implement, machine, appliance, implant, in-vitroreagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk, declare to be a medical device by order published in the 

For further information, refer Guidance Document on Definition of Medical Device

 

Overview of the Regulatory Framework

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Why Regulate Medical Devices?

  1. To address public health & safety issues
    • Assessment of safety and effectiveness of medical devices
    • Necessary information to allow public to make informed choices on medical devices
    • Usage of certain medical devices
    • Monitoring of safety and performance of medical devices in the market
  2. To facilitate medical device trade & industry
    • Growth of medical device industry
    • Local manufacturers to enter global market

Section 5(1) of Medical Device Act 2012 (Act 737) requires a medical device to be registered under the Act before it can be imported, exported or placed in the market. For that purpose, an application for the registration of a medical device must be made according to the requirement under Act 737 and in the manner determined by the Authority in Medical Device Regulation 2012.

 

Who is responsible to register a medical device?

  • Manufacturer of a medical device as defined in Section 2 of Act 737; or
  • An authorised representative appointed by a manufacturer having a principal place of business outside Malaysia, as defined in Section 2 of Act 737.

 

Overview of In-Vitro Diagnostic (IVD) Medical Device Registration

Class A In-Vitro Diagnostic (IVD) Medical Device

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 Class B, C dan D In-Vitro Device (IVD)

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For further information, refer Guidelines on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737).

Rules of Classification for In-Vitro Diagnostic (IVD) Device

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A classification of medical devices based on risk associated with the vulnerability of the human body, the technical design and the manufacture of the medical device

It uses a set of classification rules based on:

  • —Intended use
  • —The technical / scientific / medical expertise of the intended user (lay person or healthcare professional)
  • The importance of the information to the diagnosis (sole determinant or one of several), taking into consideration the natural history of the disease or disorder including presenting signs and symptoms which may guide a physician;
  • —The impact of the result (true or false) to the individual and / or to public health.

Class

Risk Level

Device examples

A

Low

Clinical Chemistry Analyser, Prepared Selective Culture Media

B

Low-Moderate

Vitamin B12, Pregnancy Self-Testing, Anti-Nuclear Antibody, Urine Test Strips

C

High-Moderate

Blood Glucose Self-Testing, HLA Typing. PSA Screening, Rubella

D

High

HIV Blood Donor Screening, HIV Blood Diagnostic

For further information, refer Guidance Document on Rules of Classification for General Medical Devices

 

Grouping for In-Vitro Diagnostic (IVD) Device

An application to register IVD devices may be made according to their grouping. For IVD devices, they may be grouped into one of the following categories as:

  1. Single
  2. Family
  3. System
  4. Set
  5. Test Kit
  6. IVD Cluster

There are 3 basic rules to determine the grouping of medical devices:

  1. One generic proprietary name;
  2. One manufacturer; and
  3. One common intended purpose.

For further information, refer Guidance Document on Product Grouping

 

Conformity Assessments

Conformity Assessments is a systematic examination of evidence generated and procedures undertaken by the manufacturer under the requirements established by the Regulatory Authority to determine that a medical device is safe and performs as intended by the manufacturer and, therefore, conforms to the Essential Principles of Safety and Performance for Medical Devices.

Elements of Conformity Assessment (CA) for the purpose of medical device registration shall comprise of the following elements:

  1. CA of quality management system (QMS);
  2. CA of post-market surveillance system (PMS);
  3. CA of technical documentation; and
  4. Declaration of conformity (DoC)

 

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Conformity assessment elements apply to Class A, B, C and D devices. According to Medical Device (Exemption) Order 2016, Class A medical devices are exempted from conformity assessment procedures by a Conformity Assessment Body under Section 7 of the Act.

 

Level of Conformity Assessment is proportional to the risk associated with a medical device (risk-based classification).

For further information, refer Guidance Document on Conformity Assessment, Guidance Document on Common Submission Dossier Template (CSDT) and Guidance Document on The Essential Principles of Safety and Performance of Medical Devices

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Conformity Assessment Procedures for Medical Devices Approved by Recognised Countries

Section 7 of Act 737 requires a medical device to undergo conformity assessment by a registered CAB prior to its registration. However, many medical devices have undergone conformity assessment and approved in countries recognized by MDA

MDA Circular Letter No 2/2014 sets the policy relating to conformity assessment for medical devices approved by countries recognized by MDA. The policy simplifies the process of conformity assessment and accelerate medical device registration under Act 737

Policy relating to conformity assessment for medical devices approved by countries recognized by MDA

  • To recognize conformity assessment and approval of medical devices placed in the market of recognized countries
  • Such medical devices need to undergo a simplified conformity assessment, ie through the process of verification of evidence obtained from the manufacturer (verification process)
  • The manner on how verification process shall be conducted is detailed out in Appendix 1 of the Circular Letter

 

For further information, refer Circular Letter of the Medical Device Authority No.2 Year 2014: Conformity Assessment Procedures for Medical Device Approved By Recognised Countries

 

Declaration of Conformity

The manufacturer shall attest that its medical device complies fully with all applicable EPSP and draws up a written Declaration of Conformity (DoC). The DoC should contain;

  • Name and address of manufacturer;
  • Particulars of medical device, classification;
  • Name, position and signature of the responsible person who has been authorized to complete the DoC on behalf of the manufacturer; and
  • CAB reviews and confirms the adequacy of the DoC by examining the supporting documents or other evidence including test report/result, applicable standards to show compliance.

Further information, refer Guidance Document on Declaration of Conformity.

 

 

Information on Fee Structure

As prescribe in the Fifth Schedule of the Medical Device Regulation; the application fee is imposed as follows; 

Application Fee for Medical Device Registration

Class

Fee Payable (RM)

A

100

B

250

C

500

D

750

Registration Fee for Medical Device Registration

Class

Fee Payable (RM)

A

-

B

1,000

C

2,000

D

3,000

A medical device that contains a medicinal product

5,000

 

For further information, refer Medical Device Regulations 2012

Related Act and Regulations:

 

Relate Circular:

Related Guidance Documents:

 

 

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my