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Circular Letter Of The Medical Device Authority

 Circular Letter Of The Medical Device Authority

In view of the problems faced by stakeholders, and an effort to facilitate the industry, Medical Device Authority (MDA) has taken into account the issues raised. After much deliberation the Authority has decided to alleviate and remove all obstacles in the implementation of Medical Device Act (Act 737) as part of our continued role in facilitating the industry.

We are pleased to inform that MDA has decided on new policies to facilitate the stakeholder and industry in the implementation of Medical Device Act (Act 737).

The policies are as follows: 

 

NO.

CIRCULAR LETTER NO.

TITLE

EFFECTIVE DATE

DOWNLOAD

1

3/2022

Refurbishment of Medical Device

9th May 2022

 Malay / English

2

2/2022

Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital or Healthcare Facilities Institution or Any Related Facilities

9th May 2022

 Malay / English

3

1/2022

Exemption from the Conformity Assessment Process by the Conformity Assessment Body (CAB) for Registration of COVID-19 Test Kit.

9th May 2022

 Malay / English

4

1/2021

Permission for Importation and Distribution of COVID-19 Self-Test Kits

14th Jul 2021

 Malay / English

5

1/2020

Transition Period for Medical Device Advertisement

20th May 2020

 Malay / English

6

1/2019

Post-Market Responsibilities for Manufacturer and Authorized Representative

Rev 1: 20th Sep 2019

15th Apr 2019

 Malay / English

7

5/2018

Additional Transition Period for Medical Device Labelling

5th Aug 2018

 Malay / English

8

4/2018

Exemption from Registration Requirement for Export Only Medical Device

Rev 1: 3rd Sep 2018

22nd May 2018

 Malay / English

9

3/2018

Recognition and Listing of Institute or Laboratory Which Is Capable to Carrying Out Clinical Evidence or Performance Evaluation for The Purpose of Conformity Assessment

22nd May 2018

 Malay / English

10

2/2018

Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital or Healthcare Facilities Institution or Any Related Facilities

Rev 2: 30th Dec 2019

Rev 1: 22nd Jul 2019

22nd May 2018

 Malay / English

11

1/2018

Licensing and Medical Device Registration of Contract Manufacturer for Application of Free Sale Certificate

Note: This circular letter withdrawn on

22nd May 2018

N/A

12

4/2017

Recognition of Institute for Medical Research (IMR) To Provide the Report or Data of Clinical Evidence or Performance Evaluation for The Purpose of Conformity Assessment by Conformity Assessment Body

2nd Oct 2017

 Malay / English

13

3/2017

Implementation and Enforcement of Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combinations Products

Rev 1: 5th Mar 2018

1st Apr 2017

 Malay / English

14

2/2017

National Preparation to Ratify Minamata Convention on Mercury

8th Jun 2017

 Malay / English

15

1/2017

Registration Requirement and Exemption from Labelling for Export Only Medical Device

Note: This circular letter withdrawn on

1st April 2017

N/A

16

5/2016

Imposition of Charges or Fees for Product Classification

8th Aug 2016

 Malay / English

17

4/2016

Transition Period for Medical Device Labelling

5th Aug 2016

 Malay / English

18

3/2016

Change of Ownership for Medical Device Registration

8th Aug 2016

 Malay / English

19

2/2016

Medical Device Procurement for Healthcare Institution

Rev 2: 15th Apr 2019

Rev 1: 1st Aug 2018

11th Jan 2016

 Malay

20

1/2016

Refurbishment of Medical Device

Rev 2: 7th Sep 2020

Rev 1: 15th Apr 2019

11th Jan 2016

 Malay / English

21

5/2014

Certification of Good Manufacturing Practice (GMP) For the Purpose of Obtaining Establishment License

22nd May 2014

 Malay / English

22

4/2014

Medical Device for Import / Export From / To Countries Without Diplomatic Ties with Malaysia

Rev 1: 3rd Sep 2018

22nd May 2014

 Malay / English

23

3/2014

Exemption of Medical Device from Registration Requirements

Note: This circular letter is no longer effective. Please refer to Medical Device Exemption (Order) 2016

22nd May 2014

N/A

24

2/2014

Conformity Assessment Procedures for Medical Device Approved by Recognised Countries

Rev 5: 25th Apr 2022

Rev 4: 13th Oct 2021

Rev 3: 15th Apr 2019

Rev 2: 20th Jan 2017

Rev 1: 4th Jan 2016

22nd May 2014

 Malay / English

25

1/2014

Establishment as Authorised Representative and Establishment Undertaking Multiple Activities

Note: This circular letter withdrawn on 17th Jun 2021. Please refer to related announcement

22nd May 2014

 Malay / English

15th June 2022

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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 [AT] mda [DOT] gov [DOT] my

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  • Last Modified: 30 November 2022.
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