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 | 1/2025 | Conformity Assessment Procedures for Medical Device Approved by Recognised Countries | 11 March 2025 | Malay / English |
| 2 | 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 |
| 3 | 1/2023 | Permission for Placement in The Market of Human Immunodeficiency Virus (HIV) Disease Self-Test Kits | 14th August 2023 | Malay / English |
| 4 | 3/2022 | Refurbishment of Medical Device | 9th May 2022 | Malay / English |
| 5 | 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 |
| 6 | 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 Note: This circular letter withdrawn on 23rd February 2024. |
9th May 2022 | Malay / English |
| 7 | 1/2021 | Permission for Importation and Distribution of COVID-19 Self-Test Kits | 14th Jul 2021 | Malay / English |
| 8 | 1/2020 | Transition Period for Medical Device Advertisement | 20th May 2020 | Malay / English |
| 9 | 1/2019 | Post-Market Responsibilities for Manufacturer and Authorized Representative | Rev 1: 20th Sep 2019 15th Apr 2019 |
Malay / English |
| 10 | 5/2018 | Additional Transition Period for Medical Device Labelling | 5th Aug 2018 | Malay / English |
| 11 | 4/2018 | Exemption from Registration Requirement for Export Only Medical Device | Rev 1: 3rd Sep 2018 22nd May 2018 |
Malay / English |
| 12 | 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 |
| 13 | 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: 30th Dec 2019 Rev 1: 22nd Jul 2019 22nd May 2018 |
Malay / English |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 |
| 17 | 2/2017 | National Preparation to Ratify Minamata Convention on Mercury | 8th Jun 2017 | Malay / English |
| 18 | 1/2017 | Registration Requirement and Exemption from Labelling for Export Only Medical Device Note: This circular letter withdrawn on |
1st April 2017 | N/A |
| 19 | 5/2016 | Imposition of Charges or Fees for Product Classification | 8th Aug 2016 | Malay / English |
| 20 | 4/2016 | Transition Period for Medical Device Labelling | 5th Aug 2016 | Malay / English |
| 21 | 3/2016 | Change of Ownership for Medical Device Registration | 8th Aug 2016 | Malay / English |
| 22 | 2/2016 | Medical Device Procurement for Healthcare Institution | Rev 2: 15th Apr 2019 Rev 1: 1st Aug 2018 11th Jan 2016 |
Malay |
| 23 | 1/2016 | Refurbishment of Medical Device Note: This circular letter has been revoked and replaced with MDA Circular Letter No.3/2022. |
Rev 2: 7th Sep 2020 Rev 1: 15th Apr 2019 11th Jan 2016 |
Malay / English |
| 24 | 5/2014 | Certification of Good Manufacturing Practice (GMP) For the Purpose of Obtaining Establishment License | 22nd May 2014 | Malay / English |
| 25 | 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: 3rd Sep 2018 22nd May 2014 |
Malay / English |
| 26 | 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 |
| 27 | 2/2014 | Conformity Assessment Procedures for Medical Device Approved by Recognised Countries Note: This Circular letter has been revoked and replaced with MDA Circular Letter No. 1/2025 |
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 |
| 28 | 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 |
Last updated: 9th April 2025
