Johari Abu Kasim’s Post

If you are in Medical Industry or have interest in it, you are welcome to hear thought provoking talk on: “Medical Device Industry : Challenges and Opportunities”.

Hyperbaric Oxygen Therapy

2-5th September 2024 KLCC- International Rubber Globe Conference & Exhibition (IRGCE) by MARGMA and Medihealth Asia 2024 (MHA2024) by PERANTIM. SEA biggest congregation of Medical Devices & Healthcare Players Malaysian Medical Devices Manufacturers Association (PERANTIM) President Mr Johari Abu Kasim together with Malaysian Rubber Gloves Manufacturers Association (MARGMA) President Mr Oon Kim Hung, The Plastic & Rubber Institute Malaysia (PRIM) Presiden Mr Ng Kha Chan , and Malaysia Rubber Council (MRC) Directors Ms Uthaya & Ms Yip in the first joint coordination meeting meeting for the upcoming 11th International Rubber Globe Conference & Exhibition (IRGCE) and Medihealth Asia 2024 (MHA2024). All parties will be collaborating to host the biggest gathering of medical devices and healthcare players in South East Asia. Margma was also represented by Dr Supra (Immediate Past President) and Mr Raymond (The Honorary Advisor). Perantim was accompanied by Mr Desmond Chong Secretary General , Treasurer Mr Muhd Muza and Chief Association Officer Ms Elaine Hew

Selamat Hari Raya Aidil Fitri Maaf Zahir & Batin from Star Medik Group

PERANTIM President putting up his case to YB Rafizi Ramli Minister of Economy in the recent Sesi Libat Urus New Deal for Business (NDFB) at Hotel Palm Garden Putrajaya. 1. Where is the reciprocal arrangement in all the FTAs if Malaysian Medical Devices Exporters have to go through 2 year of rigorous audit regime and be subjected to up to RM0.5M audit fee per product family to enter European Market when they can just walk in our Authority Office, register , pay nominal fee and start selling in our market after 2weeks? 2. We need to nurture new medical devices manufacturers & exporters as the country really lacks new players. We have huge opportunities to do this as stat shows we imported RM8.27Billion medical devices in 2023. Furthermore, last year PMX announced highest ever KKM budget at RM42.3Billion. Granted that 60%-70% was meant for managemnt, salary, maintenance etc. Yet there is good portion for business development for the local player if good structured program can be formulated. In 2021 , Indonesian Presiden mandated the govt to stop importing meddev if they can be manufactured locally. This has spurred rapid meddev manufacturing activities locally. Malaysia can learn a thing or two from this.

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FTAs - MITI Dialogue 2024 1. Thank you YB Mulia Senator DSU Tengku Zafrul Aziz & MITI for providing an avenue for industrialists to voice our feedbacks , concerns, comments and complaints 2. The country is signing a record breaking FTAs especially with EU Countries and European Non EU Countries. The industries are very much welcome this effort and initiative as it help expedite the market expansion and boost opportunities 3. Nonetheless many are concerned and some are still in the dark of the how the reciprocal part of these FTAs work. 4. During the dialogue , we gave an example how fast an European Medical Device company can enter our market. They can just walk in into our Medical Device Authority (MDA) office, or do the online and other necessary registration, and can start selling after approval in 7 days 5. For us to enter their market, Malaysian Meddev manufacturers have to obtain CE Certifications by undergoing rigorous international audit between 6-30 months with the cost of USD50K-USD150K per product family. 6. Where is the reciprocal part? 7. We are hoping that our country is not being short-changed in the name of market liberalisation and equal opportunities 8. Of course there are other issues of ESG, HR especially Local Certified Auditors , Taxes inconsistencies, Innovations, and many others which have been brought forward during the dialogue and also previously. 9. Industrialists sees the record RM41.2Billion for MOH in 2024 as a huge opportunity to develop more local manufacturers and exporters. 10. We also in support Sementa’s Lai-Lyn Fong suggestions to bring back ETA grants to associations We remain. Johari Abu Kasim Perantim President

The Minister of Entrepreneur and Cooperatives Development, YB Datuk Ewon Benedick hosted Dialogue with The Key Industry players on 15 January 2024. YB Minister was accompanied by his Deputy Minister, Madam Chief Secretary, Chairman & CEO of SmeCorp. PERANTIM relayed the following feedbacks and concerns: 1. There must be more efforts to develop more local players in medical device manufacturing & exporting. Last year when tabling the budget, PMX announced the highest ever KKM allocation for 2024 at RM41.2Billion. There are huge opportunities to create initiatives for local industry enhancement and development. We should emulate Bapak President Joko Widodo direction in 2022 after announcing USD140Billion KKM budget : “Jika bisa di fabrikasi di sini, kami tidak akan impor”. 2. The barrier to entry is getting higher and cost escalation in maintaining certifications and audits are almost prohibitive. Export to Europe is currently dampened by increase in insurances and logistics costs due to war, weakened ringgit and competition. There must be a well concerted & structured effort by both government and industry to manage & combat these. 3. The govt is signing record numbers of FTAs. The industry is in total support as this will help expedite the market expansion and boost opportunities. Nonetheless many are concerned and some are still in the dark of the how the reciprocal part of these FTAs work. We are hoping not to be short-changed in the name of market liberalisation. 4. When there are problems, there lies opportunities. · The new Ibu Kota Negara Nusantara Indonesia pose logistical advantage to Borneo Meddev manufacturers and exporters ( #1) · There is dire need to develop Malaysian very own audit establishment sanctioned by EU. This will expedite audit process and lower the cost. The cream is at the opportunity to develop local talents for international auditing. #perantim #kuskop #smecorp #meddevissues