APACMed and MDA Partner for Change Management Workshop 

The timely approval of reliable diagnostics and life-saving medical technologies is crucial for effective public health management. However, regulatory authorities face a complex challenge: balancing stringent safety and efficacy standards with ensuring timely access to these critical innovations. 

Capacity building and agility is key to navigating this balancing act. APACMed’s Regulatory Affairs Committee’s recent collaboration with the Medical Device Authority Malaysia (MDA) through a Change Management Workshop exemplifies this commitment.  

The 3-hour workshop, held on 2 February 2024, included a presentation on the outlook of change management globally by Dr Adelheid Schneider, which highlighted best practices from other countries, and a review of the Global Harmonisation Working Party (GHWP) guidance document and details of the Predetermined Change Control Plans (PCCP).   

This was followed by an insightful sharing by MDA on their draft Change Management Document and a brief workshop on identifying differences between MDA and international guidance documents for the attendees.   

This workshop served as a comprehensive avenue for regulators to enrich their knowledge on change management and enhance their expertise in reviewing guidance documents.  

Join us for a slew of other workshops planned by the APACMed Regulatory Affairs Committee this year as it continues in its drive to build regional regulatory capability.   

APACMed Engages with Singapore HSA – Discussing Industry Updates and Collaboration 

Leaders from APACMed and the Singapore Manufacturing Federation-Medical Technology Industry Group engaged in insightful discussions in an industry dialogue session hosted by Senior Health Sciences Authority (HSA) leaders including CEO, Dr Mimi Choong and Associate Professor Cheng Leng Chan. 

HSA shared that applications and enquiries are returning to pre-pandemic levels and issued a call for early submission of Unique Device Identification (UDI) to MedTech manufacturers. From 2025, medical device companies will need to have their ISO 13485 certifications obtained from Singapore Accreditation Council (SAC)-accredited certification bodies (CBs) in order to apply for a license. They also announced a new initiative to facilitate SaMD software changes. 

APACMed looks forward to fostering more of such collaborative advancements with the continued aim of accelerating patient access. 

APACMed Meets with Indonesian Ministry of Health on Post-Market Surveillance, Regulatory Reliance, and Software as a Medical Device (SaMD) Regulations 

APACMed had the privilege of engaging in a productive discussion with the Director General of the Indonesian Ministry of Health at the MOH Office in Jakarta on 21 March 2024. The discussion covered crucial topics, including e-IFU, Post-Market Surveillance, Regulatory Reliance, and Software as a Medical Device (SaMD) Regulations, highlighting our dedication to enabling the advancement of topics associated with MedTech’s regulatory landscape.