Malaysia: Medical Device Regulatory Updates

August 28, 2019

Circular Letter

 

No. 1 Year 2019: Post-market Responsibility for Manufacturer and Authorized Representative Who Have Closed Their Business; And AR Who Have Closed Their Business, Replaced By Another AR After Placing the Medical Device in the Market

 

  • Manufacturer/AR shall be responsible for post-market issues at least in accordance with the projected useful life of the medical device as determined by the manufacturer.

  • The newly appointed AR shall be responsible for post-market issues of the medical device.

 

No. 2 Year 2018 Revision 1: Control of Orphaned, Obsolete and Discontinued Medical Device In Hospital, Healthcare Facilities Institution or Any Related Facilities

 

  • The purpose of the circular is to set the implementation and enforcement under the Medical Device Act 2012 (Act 737) relating to control of orphaned, obsolete and discontinued medical device in hospital, healthcare facilities institution or any related facilities in Malaysia.

  • All medical devices must be registered before being imported, exported or placed in Malaysian market. However, there are orphaned, obsolete and discontinued medical devices in hospitals or healthcare facilities institution which is not registered and still being used. Some of these medical devices cannot be registered because the technical documentation of the medical device is unavailable and unable to comply with registration requirements.

  • Therefore, to impose certain controls to the healthcare facilities institution that are still continuing to use such medical devices, as well as ensure that medical services in hospital or healthcare facilities institution are uninterrupted, a policy is developed to control this medical device.

  • The circular shall be used as part of requirements under Act 737 and shall be effective from the date it is issued (22nd July 2019).

 

 

Guidance Documents

 

1 regulatory requirement and 15 guidance documents has been published in MDA website.

22 guidance documents are still under development process.

 

 

New Release MDA/GD/0051: Guidance Document on Notification Of Export Only Medical Device


Medical Device Authority (MDA) has prepared a Guidance Document, MDA/GD/0051: Notification of Export Only Medical Device to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.
 
The importation, exportation, or placement of a medical device in the Malaysia market requires the medical device to be registered under Medical Device Act 2012 (Act 737). The Circular Letter of Medical Device Authority No. 4 Year 2018 exempts medical devices that are for export only from registration requirements and only require notification to the Authority. An “Acknowledgement on Notification” letter issued by MDA then permits the device to be exported.

 

The new document is to provide guidance on notification of export only medical device. This document applies to all products that fall within the definition of medical device, as defined in Guidance Document MDA/GD/0006, Definition of Medical Device, including in vitro diagnostic (IVD) medical devices.

 

 

Requirements for Application of Certificate of Free Sale (CFS) for Contract Manufacturers (MDA/GD/0045)

 

• Section 5(1) of Act 737, requires all medical devices are registered before they can be imported, exported or placed in the market.

• However, export only medical devices are exempted from registration as per Circular Letter of Medical Device Authority No. 4 Year 2018 Exemption from registration requirement for export only medical device.

• Contract manufacturing is where production of medical devices is done by one firm, under the label of another firm. Therefore, a contract manufacturer does not fall into the definition of “manufacturer” as defined in Section 2 of Act 737.

• For the purpose of exporting their medical devices, contract manufacturers often require issuance of CFS. This guidance document is developed to assist contract manufacturers in their application for CFS.

 

 

Guidance Documents To Be Published Soon

 

1. Distribution Records

2. Complaint Handling

3. Field Corrective Action

4. Mandatory Problem reporting

5. Medical Device Recall

6. Requirement of Installation, Testing & Commissioning, and Acceptance of Medical Device

7. Codes of Advertisement for Medical Devices

8. Requirements for application of certificate of free sale (CFS) for contract manufacturers

9. Requirements for conformity assessment body (CAB) registration

 

 

Reference: Medical Device Authority, Ministry of Health Malaysia

 

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