In early October, Malaysia’s Medical Device Authority (MDA), has released a guidance document for companies in the medical device space. An Establishment License delineates the local requirements for manufacturing, exporting, and importing of devices in Malaysia. The guidance document provides definitions for distributors, good distribution practices, tendering agents, etc. To qualify for an establishment license, first, an authorization letter is required. Also, the entity must have an office in Malaysia and a specified person to manage any regulatory issues. In addition, the entity must have a quality system (QMS) and be responsible for post-market activities. Both the authorized representative and the manufacturer are responsible for post-market activities even if they terminate authorization or manufacturing for a period of time.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.mda.gov.my/documents/guidance-documents/2217-guidance-document-licensing-for-establishment-second-edition/file.html