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Malaysia MDA Product Classification: Mandatory Online Submissions by August 2026
Malaysia's Medical Device Authority (MDA) is mandating fully online submissions for all medical device product classification applications starting A…
2 months, 2 weeks ago
FDA's MDUFA VI Draft Commitment Letter: Key Proposals and the August 7 Comment Deadline
This episode details the US FDA's newly released draft commitment letter for the sixth Medical Device User Fee Act (MDUFA VI), which will govern fisc…
2 months, 2 weeks ago
South Korea MFDS Proposal for Digital Medical Device Testing: What Manufacturers Need to Know
South Korea's Ministry of Food and Drug Safety (MFDS) has released Legislative Notice No. 2026-341, a proposal to amend the rules for medical device …
2 months, 2 weeks ago
Saudi Arabia SFDA Medical Device Advertising: New MDS-REQ 8 Requirements for Manufacturers
This episode provides a detailed analysis of the Saudi Food and Drug Authority's (SFDA) new requirements for medical device advertising, outlined in …
2 months, 3 weeks ago
India's 2026 CDSCO Guidance on Medical Device Software (MDSW): Key Compliance Steps
This episode covers India's CDSCO final guidance for Medical Device Software (MDSW), released on July 23, 2026. We discuss the key compliance require…
2 months, 3 weeks ago
FDA eMDR System Enhancements 2026: A Guide for Medical Device Manufacturers
On July 20, 2026, the US FDA announced major enhancements to the electronic Medical Device Reporting (eMDR) system, impacting all manufacturers requi…
2 months, 3 weeks ago
China NMPA Draft GMP Inspection Guideline: Risk-Based Audits and Critical Check Items
China's NMPA has released a draft 'Guideline for Inspection under the Medical Device Good Manufacturing Practices', signaling a major shift towards a…
2 months, 3 weeks ago
ANVISA Medical Device Regulation 2026: Brazil and Chile's Technical Exchange and Its Impact
Brazil's ANVISA and Chile's ISP held a technical exchange from July 6-10, 2026, to deepen regulatory cooperation. This episode explores the key topic…
2 months, 3 weeks ago
ANVISA Technovigilance Changes in Brazil: What to Expect After the Public Consultation
This episode covers the recent closure of Brazil ANVISA's public consultation (Call for Contributions No. 4/2026) on a new technovigilance framework.…
2 months, 3 weeks ago
South Korea Medical Device Act 2026: MFDS QMS and Distribution Rule Changes
This episode details the significant amendments to South Korea's Medical Device Act, effective July 1, 2026. We cover the two key changes from the Mi…
2 months, 3 weeks ago