Manufacturers seeking licenses to sell high-risk medical devices in Thailand will have a route to do so more rapidly and at less cost under a new agreement struck between regulatory authorities in the country and their counterparts in Singapore.
Under the agreement, the Food and Drug Administration of Thailand will allow fast-track registration of Class 4 devices already approved by regulators in Singapore. That will save manufacturers the cost of and time of conducting a separate expert review process in Thailand. To be eligible, applicants will have to submit evidence that the device has been registered in Singapore, among other proof and documentation.
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://uk.practicallaw.thomsonreuters.com/6-500-8489?transitionType=Default&contextData=(sc.Default)