Surat Pekeliling

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	1/2024	Medical Devices Imported From or Exported to Countries Without Diplomatic Ties with Malaysia Which Are Subjected to Trade Restrictions	26th April 2024	Malay / English
2	1/2023	Permission for Placement in The Market of Human Immunodeficiency Virus (HIV) Disease Self-Test Kits	14th August 2023	Malay / English
3	3/2022	Refurbishment of Medical Device	9^th May 2022	Malay / English
4	2/2022	Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital or Healthcare Facilities Institution or Any Related Facilities	9^th May 2022	Malay / English
5	1/2022	Exemption from the Conformity Assessment Process by the Conformity Assessment Body (CAB) for Registration of COVID-19 Test Kit. Note: This circular letter withdrawn on 23rd February 2024.	9^th May 2022	Malay / English
6	1/2021	Permission for Importation and Distribution of COVID-19 Self-Test Kits	14^th Jul 2021	Malay / English
7	1/2020	Transition Period for Medical Device Advertisement	20^th May 2020	Malay / English
8	1/2019	Post-Market Responsibilities for Manufacturer and Authorized Representative	Rev 1: 20^th Sep 2019 15^th Apr 2019	Malay / English
9	5/2018	Additional Transition Period for Medical Device Labelling	5^th Aug 2018	Malay / English
10	4/2018	Exemption from Registration Requirement for Export Only Medical Device	Rev 1: 3^rd Sep 2018 22^nd May 2018	Malay / English
11	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	22^nd May 2018	Malay / English
12	2/2018	Control of Orphaned, Obsolete and Discontinued Medical Device in Hospital or Healthcare Facilities Institution or Any Related Facilities Note: This circular letter has been revoked and replaced with MDA Circular Letter No.2/2022.	Rev 2: 30^th Dec 2019 Rev 1: 22^nd Jul 2019 22^nd May 2018	Malay / English
13	1/2018	Licensing and Medical Device Registration of Contract Manufacturer for Application of Free Sale Certificate Note: This circular letter withdrawn on	22^nd May 2018	N/A
14	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	2^nd Oct 2017	Malay / English
15	3/2017	Implementation and Enforcement of Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combinations Products	Rev 1: 5^th Mar 2018 1^st Apr 2017	Malay / English
16	2/2017	National Preparation to Ratify Minamata Convention on Mercury	8^th Jun 2017	Malay / English
17	1/2017	Registration Requirement and Exemption from Labelling for Export Only Medical Device Note: This circular letter withdrawn on	1^st April 2017	N/A
18	5/2016	Imposition of Charges or Fees for Product Classification	8^th Aug 2016	Malay / English
19	4/2016	Transition Period for Medical Device Labelling	5^th Aug 2016	Malay / English
20	3/2016	Change of Ownership for Medical Device Registration	8^th Aug 2016	Malay / English
21	2/2016	Medical Device Procurement for Healthcare Institution	Rev 2: 15^th Apr 2019 Rev 1: 1^st Aug 2018 11^th Jan 2016	Malay
22	1/2016	Refurbishment of Medical Device Note: This circular letter has been revoked and replaced with MDA Circular Letter No.3/2022.	Rev 2: 7^th Sep 2020 Rev 1: 15^th Apr 2019 11^th Jan 2016	Malay / English
23	5/2014	Certification of Good Manufacturing Practice (GMP) For the Purpose of Obtaining Establishment License	22^nd May 2014	Malay / English
24	4/2014	Medical Device for Import / Export From / To Countries Without Diplomatic Ties with Malaysia Note: This circular letter has been revoked and replaced with MDA Circular Letter No.1/2024	Rev 1: 3^rd Sep 2018 22^nd May 2014	Malay / English
25	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	22^nd May 2014	N/A
26	2/2014	Conformity Assessment Procedures for Medical Device Approved by Recognised Countries	Rev 5: 25^th Apr 2022 Rev 4: 13^th Oct 2021 Rev 3: 15^th Apr 2019 Rev 2: 20^th Jan 2017 Rev 1: 4^th Jan 2016 22^nd May 2014	Malay / English
27	1/2014	Establishment as Authorised Representative and Establishment Undertaking Multiple Activities Note: This circular letter withdrawn on 17^th Jun 2021. Please refer to related announcement	22^nd May 2014	Malay / English

6th May 2024