India’s Ministry of Health and Family Welfare has proposed amendments to the 2017 Medical Devices Rules to simplify and speed up the licensing process for medical device manufacturing. A draft notification was published in the Official Gazette for public comment, with the changes intended to improve ease of doing business while maintaining existing safety, quality, and performance standards. Under the proposal, the timeline to get a new medical device manufacturing license for Class B devices (such as blood pressure monitors, hypodermic needles, and pulse oximeters) would be cut from 140 days to 115 days. For Class C and D devices (including cardiac stents and hip and knee implants), the timeline would drop from 105 days to 90 days. The draft also introduces clearly defined sub-timelines for each stage of the process — application evaluation, audits by notified bodies, compliance verification, and license issuance.
Malaysia’s Medical Device Authority is moving device product classification applications fully online starting August 1, 2026, retiring the current Google Form in favor of a dedicated Product Classification Application System. The agency says the switch is meant to make submissions more organized and easier to track. Once an application is approved, the classification letter will go out by email only, as the MDA is discontinuing mailed hard copies. Applicants are encouraged to get familiar with the new system ahead of the rollout, with more detailed instructions expected closer to the launch date.
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.