The South East Asian medical device market is growing rapidly. Medical device companies are importing products into these emerging markets and also looking to set up collaborations for local manufacturing in the South East Asian region including Malaysia, India, Philippines, Indonesia etc. Regulatory consultants assist medical device manufacturers navigate the differential landscapes of these markets. Choosing the right medical device distributors and manufacturing partners in these emerging economies is essential.
The medical device industry growth of Malaysia is projected to be 12% by the Association of Malaysian Medical Industries (AMMI) this year. The exports are expected to be RM 15.11 bil based on the projections said Chairman Hitendra Joshi. The organic growth of the industry and reinvesting companies is the reason why the growth rate is expected to be higher than the global growth rate of 8%. READ ALSO: Regulatory Process of South East Asian markets, Indian Medical Device Market.
“Representing the leading medical device companies, the 56 member AMMI accounts more than half the export revenue of medical devices Made in Malaysia. Due to the shift towards higher value medical devices the members of AMMI spent around RM54.83mil on R and D which is increase from RM43mil spent two years before” added Hitendra. LEARN MORE about Registration process in other SE Asia markets.
Other News
CDSCO Issues Guidelines on Medical Device License Retention
New Delhi, May 15, 2024 — The Central Drugs Standard Control Organization (CDSCO) has released a circular (F. No. MED-15/35/2024-eOffice) on the retention of medical device licenses and certificates under the Medical Devices Rules, 2017. […]
Read More
India Medical Device Pricing Strategy: Ensuring Growth & Affordability
India’s National Pharmaceutical Pricing Authority (NPPA) is developing a specialized India medical device pricing strategy for medical devices, transitioning away from the conventional drug-centric framework. This innovative strategy will incorporate international pricing tactics tailored to […]
Read MoreImports of High-Value Medical Equipment
High-Value Medical Equipment The Central Drugs Standard Control Organization (CDSCO) and the Central Board of Indirect Taxes & Customs have released a new circular, “F.No.401/40/2021-Cus.III,” detailing updated policies on the import of used high-end medical […]
Read MoreSEC Committee: Pioneering Medical Approvals
New important article released by Central Drugs Standard Control Organization (CDSCO) titled “SEC – Special Expert Committee, Medical Devices”. Key highlights include the streamlined processes for CDSCO application evaluations, preparation and significance of briefing materials, […]
Read More
ErlySign Oral Cancer Detection Technology Gets CDSCO Nod
ErlySign, a Nagpur-based biotech startup, has received approval from the Central Drugs Standard Control Organization (CDSCO) to conduct large-scale clinical trials for its novel oral cancer detection technology. The approval for ErlySign follows a rigorous […]
Read MoreAdditional Steps Announced by FDA to Modernize Clinical Trials
The U.S. Food and Drug Administration has made draft guidance available with updated recommendations for good clinical practices (GCPs), which are intended to modernize the clinical trial design and conduct while maintaining data integrity and […]
Read MoreAccreditation and Registration Numbers for Foreign Manufacturers Publication by PMDA
This article deals In accordance with the Pharmaceuticals and Medical Devices Act (PMD Act) of Japan, foreign businesses that wish to produce pharmaceuticals, quackery products, active pharmaceutical ingredients (APIs), or medical devices abroad and import […]
Read MoreBSI New Certification to Mitigate Antimicrobial Resistance Risk in Antibiotic Manufacturing
BSI, the business improvement and standards company, has developed a new certification to mitigate the risk of antimicrobial resistance (AMR) in antibiotic manufacturing. The certification, called the Minimized Risk of Antimicrobial Resistance (AMR) certification, will […]
Read More
