Page 25 - AMMI Annual Report 2016

COMMITTEE LEADER:
Ÿ Ong Yean Ting (Johnson & Johnson Sdn. Bhd.) – un l September 2016
Ÿ Dato' Dr Haminnuddin Hj. Abdul Hamid (Ideal Healthcare Sdn. Bhd.) – from October 2016

MEMBERS:
Ÿ Mr Christophe Marque (Stereo Sdn. Bhd.)
Ÿ Ms Gan Poh Siew (Haemone cs Malaysia Sdn. Bhd.)
Ÿ Ms Chuah Chiew Teng (3M Malaysia Sdn. Bhd.)
Ÿ Ms Chuah Siew See (Teleflex Medical Sdn. Bhd.)
Ÿ Ms Quek Lang Fah (B.Braun Medical Industries Sdn. Bhd.)
Ÿ Mr Jason Ng (UWC Healthcare Manufacturing Sdn. Bhd.)
Ÿ Mr Muhammad Juzaili Jamil (Ideal Healthcare Sdn. Bhd.)
Ÿ Mr Alfred Ho (Texchem Life Sciences Sdn. Bhd.)
Ÿ Ms Queenie Lee Ching Hoay (KLS Mar n Sdn. Bhd.)
Ÿ Ms Grace Wong (Johnson & Johnson Sdn. Bhd.)
Ÿ Ms Chloe Tan (Medtronic-Mediquip Sdn. Bhd.)

MEETINGS AND FEEDBACK

25 May: Industry Standards Commi ee – Medical Device (ISC R) mee ng, SIRIM, Shah Alam
Ms Chuah Chiew Teng (3M Malaysia Sdn. Bhd.) represented AMMI in the mee ng.
Key takeaways from the mee ng:
1. Updates on Good Lab Prac ce (GLP) facili es in Malaysia
• Biocompa bility Lab or “Makmal Bioserasi” in UKM (for biocompa bility studies only)
- will be ready soon.
• MyBioScienceLab (MBSL) in Malacca (for full range of ISO10993 tests)
- 90% of its infrastructure is completed.
• Ins tute for Medical Research (IMR) lab is cer fied and available for toxicology tests.
2. ISC R is officially adop ng the ISO13485: 2016. Companies cer fied to the earlier versi on.
(MS ISO13485: 2006) has 3 years for transi on to the latest version, which ends March 2019.

30 May : AMMI Feedback to Medical Device Authority (MDA) on Medical Device Labelling
Implementa on
AMMI collec vely proposed a 3-year transi onal period. Among jus fica ons given were me and
capital investments required for purchase of new label prin ng equipment. Refer to full details on
page 25.

AMMI Annual Report 2016 23