Post Market Step up enforcements by Singapore HSA and Malaysia MDA

June 28, 2019

SINGAPORE: HSA Informs Public Regarding Risk of Breast Implants 

 

BIA-ALCL is a cancer of the immune system and not a type of breast cancer. It usually involves a swelling around the implant and has been reported to occur as early as 1 year and as late as 37 years after the breast implant surgery. If diagnosed early, BIA-ALCL can be successfully treated with surgery. However, in cases where the cancer has spread to other parts of the body, further treatment such as radiation or chemotherapy and targeted immunotherapy have been used.

 

Since 2017, following emerging scientific reports on BIA-ALCL, HSA has required manufacturers of breast implants to include cautionary statements regarding the risk of BIA-ALCL in the package inserts of breast implants registered in Singapore.  HSA had also informed relevant healthcare professionals in October 2017 to highlight the risk of BIA-ALCL and the possible association with textured surface breast implants to patients, and to report any BIA-ALCL cases they encounter to HSA.   There are currently eight registered brands of breast implants in Singapore. Macro-textured breast implants are associated with the highest risk of BIA-ALCL, and the Allergan Natrelle breast implant is the only macro-textured breast implant registered in Singapore.  HSA has taken the precautionary measure of disallowing the sale of the Allergan Natrelle breast implant in Singapore since April 2019. This decision was supported by the Expert Panel.

 

HSA advises persons considering breast implants for reconstruction or augmentation purposes to discuss their options with their doctors, including the risks and benefits of different types of implants.  

 

Link: https://www.hsa.gov.sg/content/hsa/en/News_Events/Press_Releases/2019/biaalcl.html

 

 

MALAYSIA: Post-Market Responsibilities for Manufacturer and Authorized Representative (AR)

 

The purpose of this news is  to set the implementation and enforcement under the Medical Device Act 2019 (Act 737) relating to post-market responsibilities for manufacturer and authorized representative who have cease business after placing medical device in the Malaysian market. There are 3 situations involving establishment in Malaysia:

 

 (a) Authorized Representative (AR) closed its business and no replacement after placing medical device in the market

 (b) AR closed its business after placing medical device in the market and being replaced by another AR

 (c) Manufacturers closed its business and have no replacement after placing medical device in the market

 

This will cause problems in the even of a post-market issue such as complaints, incidents and recall of the medical device. The need for accountability for post-market issues should be developed to ensure that safe and effective medical devices can be controlled.

The Medical Device Authority Meeting No 1/2019 has decided to set the implementation and enforcement control of post-market responsibility for manufacturer and authorized representative as follows:

 

 (a) AR closed its business and no replacement after placing medical device in the market:

  • 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.

 

 (b) AR closed its business after placing medical device in the medical device in the market and being replaced by another AR

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

 

 (c) Manufacturers closed its business and have no replacement after placing medical device in the market

  • The manufacturer 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.

 

Therefore, all local and foreign manufacturers of medical devices keen in entering the market for medical devices in Malaysia must consider the above and find methods to handle the post-market activities of their devices efficiently until the expiry of the expected useful life.

 

Click here for more information. 

 

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