Asia
(Less China Mainland)
The Asia-Pacific medical device market has experienced substantial growth, driven by factors like increased healthcare spending, technological advancements, and a growing awareness of health issues. Countries such as Japan, Korean and India have emerged as key players, witnessing a rise in demand for medical devices and diagnostic technologies. The market reflects a dynamic landscape with both global and local companies contributing to competition, offering a range of innovative solutions from advanced medical technologies to cost-effective alternatives.
Navigating the Asia-Pacific medical device market poses challenges due to a diverse regulatory landscape across countries. Regulatory compliance, post-market surveillance, language barriers, and inconsistencies in enforcement further contribute to the complexities, requiring manufacturers to stay vigilant and informed to successfully navigate the varied regulatory environments in the region.
Accel can play a pivotal role in assisting medical device manufacturers in overcoming regulatory challenges in the Asia-Pacific region. Our expertise lies in providing comprehensive regulatory intelligence and guidance, helping clients navigate the diverse and evolving regulatory landscapes of different countries. We can assist in the development of effective regulatory strategies, streamline documentation processes, and facilitate communication with local regulatory authorities. With a deep understanding of language nuances, cultural considerations, and the intricacies of each regulatory environment, Accel can act as a valuable partner, enabling medical device companies to successfully navigate the complex regulatory terrain in the Asia-Pacific region.
Japan
Explore Accel’s expertise in guiding you through the intricate landscape of medical device registration and regulatory pathways for the distribution of medical devices and IVDs in Japan. Connect with Accel to initiate a complimentary consultation delving into the possibilities for your medical device or IVD within the Japanese medical device market.
- Medical Device/IVD Registration in Pharmaceuticals and Medical Device Agency (PMDA)
- Pre-Market Submission (PMS), Pre-Market Certification (PMC), Pre-Market Approval (PMA)
- PMDA Clinical Evaluation/Study Consultation
- Local Clinical Trial
- GLP/GCP/GPSP Compliance Consultation
- GMP/QMS/GCTP Inspections Support
- Local Independent License Holding
- Post Market Surveillance
Hong Kong
Accel is at your service to help you navigate the complex procedures involved in registering medical devices and understanding the regulatory pathway for distributing medical devices and IVDs in Hong Kong. Feel free to contact Asia Actual for a complimentary consultation where we can discuss the potential for your medical device or IVD in this thriving market.
- Medical Device/IVD Registration in Medical Device Division (MDD)
- Medical Device Classification: Class I, Class II, Class III, Class IV
- IVD Classification: Class A, Class B, Class C, Class D
- Local Responsible Person (LRP)
- Registration Modification
- Adverse Event Reporting
India
Accel is ready to assist you in navigating the intricate process of registering medical devices and following the regulations for distributing medical devices and IVDs in India.
- Medical Device/IVD Registration in Central Drugs Standard Control Organization (CDSCO)
- Medical Device/IVD Classification: Class A, Class B, Class C & Class D
- Medical Device/IVD Grouping
- Local Clinical Trial for Risky Medical Device without Predicates
- Good Manufacturing Practice (GMP) Compliance
- Authorized Representative
South Korea
Accel is here to assist you in understanding the rules for getting your medical device approved and distributed in South Korea. Contact us for a free chat about the possibilities for your medical device or IVD in the South Korean market.
- Medical Device/IVD Registration in Ministry of Food and Drug Safety (MFDS)
- Medical Device/IVD Classification: Class I, Class II, III, IV with Substantial Equivalent (S.E.), Class II, III, IV without S.E.
- Pre-Market Notification (PMN) and Pre-Market Approval (PMA)
- Korean Good Manufacturing Practice (KGMP) Certification
- Local Clinical Trial in Qualified Clinical Centers
- Korean License Holder (KLH)
- Post Market Surveillance: Sales Data Record & Adverse Event Reporting
Singapore
Accel is here to assist you in understanding the rules for getting your medical device approved and distributed in Singapore. Contact us for a free chat about the possibilities for your medical device or IVD in the Singaporean market.
- Medical Device/IVD Registration in Health Sciences Authority (HSA)
- Medical Device/IVD Classification: Class A, Class B, Class C, Class D
- Registration Pathways: Immediate, Expedited, Abridged, and Full Registration
- Good Distribution Practice for Medical Devices (GDPMDS) Certification
- Local Clinical Trial in Qualified Clinical Centers
- Singapore License Holder (SLH)
- Post Market Surveillance: Sales Data Record & Adverse Event Reporting
Malaysia
In Malaysia, Pacific Bridge Medical has knowledgeable partners available locally to assist with regulatory affairs for medical devices and pharmaceuticals, along with the development of business strategies.
- Medical Device/IVD Registration in Medical Device Authority (MDA)
- Medical Device/IVD Classification: Class A, Class B, Class C, Class D
- Medical Device Grouping
- Conformity Assessment: Quality Management System (QMS), Post-Market Surveillance System (PMS), Technical Documentation
- Local Clinical Trial
- Labeling Requirements
- Change Notification for Registered Medical Device
- Malaysia License Holder
