11 October 2022, Nilai
Industry Discussion Between Industrial Centre of Innovation (IC-I) Biomedical (SIRIM) and Persatuan Pengilang-Pengilang Peranti Perubatan Malaysia (PERANTIM)
Some of Crucial Points Discussed:
There is a dire need to review and relook into the Meddev eco-system workflow especially when come to new innovation filing, testing, registration, support and sales at the authority’s level. There are various claims and complaints of delays which demand to be improvised. Some effected stakeholders include MDA, KKM, MRANTI, Ethical Committee etc.
Malaysian Medical Audit eco-system lacks expert personnel either at senior level, especially during auditing and testing processes, reviews, confirmation to authorities (especially Malaysian based CABs), all the way to the entry level (post graduates in bio medical). The meeting quorum expressed its concern on shortages of Bio Medical talents in the industry. It also took note of SIRIM’s current engagement with Universities and PERANTIM’s engagements with UIA, USIM, UNIMAP and UUM to counter this issue.
Critical take home points from PERANTIM:
• SIRIM has proven to have some of the world standard labs, test facilities and high qualified personnel. However, many of the test and reviews are not recognized internationally especially so when the local manufacturers pursuing International certification like CE and USFDA. This was also related by one company who has been on SIRIM’s incubators program only to redo all the tests when applying for CE Mark. PERANTIM would like to urge SIRIM to be look into becoming an international certifying body like TUV, BSI, SGS, DNV and able to certify CE MARK to Malaysian MEDDEV Manufacturers.
• Many Grant recipient members feel that the stringent due diligences and strict company financial reviews done by certain financial institutions during selection and disbursement have cause more delays and unnecessary bureaucracies. These sometimes defeat the purpose of fast and rapid development the grants supposed to do. PERANTIM suggest that MEDDEV Industrialist with financial/banking background to be part of monitoring process at the GRANT agencies.
PERANTIM would like to thank members who participated including Dato’ Sri Dr Hj Haminuddin (Ideal Health Care Sdn Bhd), Mr Ng Keong Ho (Epsilon), Ms Nasraya Marlina (Muzamal Industries Sdn Bhd), Dr Hyzan Mohd Yusof and En Zulkifli (OSA Technology Sdn Bhd), Dr Fazilah Fazan (Granulab (M) Sdn Bhd), Dr Norayati Abd Majid (Hana Medic Sdn Bhd), Mr Zulkefli Mohd Nor (Worldwide Medivest Sdn Bhd), Mr Azrin Affendi (Ummah Synergy Ventures (M) Sdn Bhd, and President himself Mr. Johari Abu Kasim (Star Medik Sdn Bhd). Special Thank Star Medik Sdn Bhd and Datuk Haji Tajuddin for hosting the venue of the meeting.
