Regulatory Service
LICENSE HOLDING SERVICES
Expanding into new markets is a key milestone for any company looking to grow its business. ASEAN countries, with its large and dynamic economy, presents an attractive opportunity for companies seeking to tap into Southeast Asia’s potential. However, entering the Asean market requires careful consideration and compliance with local regulations.
A Company has three options:
1. Establishing a Local Entity
Advantages :
- Greater control over operations, distribution, and branding.
Disadvantages :
- Requires a significant commitment to time, resources, and a deep understanding of local regulations.
2. Appointing a Local Distributor
Advantages :
- Local distributor can help with sales and commercial activities.
Disadvantages :
- There will be exclusivity prohibiting on appointing more than one distributor.
- Companies should carefully select a reliable and reputable distributor to maintain brand reputation and ensure compliance
3. appointing an Independent License Holder - Mursmedic
Advantages :
- Margin-Free Importation
- Product Registration Assistance:
- E-Catalogue Submission and Monitoring
- Post-Market Support
- Multiple Distributor Appointments
Disadvantages :
- Requires back-to-back process due to the transparency.
Product Registration Service
All regulated products distributed in ASEAN countries must be registered to the authority. The requirement for product registration consists of administration and technical documents such as certificate of free sales (CFS), ISO of manufacturing site, and product specification documents. The timeline for product registration will takes 3 months until 2 Years depending on the product category.
Why registering your product with us?
01. Has 14 years of experience in product registration
02. Seamless and smooth process
03. Guarantee of approved submission
04. Faster process
Permit and Certification
Permit management and certification plays a crucial role in ASEAN’s business environment by enhancing customer satisfaction, competitiveness, and compliance with international standards. It also contributes to increased productivity, cost reduction, risk management, and sustainability, ultimately supporting the growth and success of businesses in the country.
Why choosing us as your certification partner?
01. Help with the system establishment
02. Meticulous assessment to the facility and system
03. Assistance in audit process
04. Provides basic training
Training & Development
Training and development encompass educational efforts that boost employee knowledge, productivity, and skills while enhancing task performance. This is essential for organizations to stay competitive by improving their human capital, reducing turnover, and fostering a positive corporate culture. At Mursmedic Group, we’re committed to sharing our expertise to equip clients with the skills and knowledge needed for sustained market competitiveness. As an approved HRDF training provider, our registered trainers and courses help companies deliver effective employee development opportunities.
ISO Consultation
- ISO 9001 – Quality Management System
- ISO 14001 – Environmental Management System
- ISO 45001 – OSH Management System
- ISO 27001 – Information Security Management System
- ISO 50001 – Energy Management System
- IATF 16949 – Automotive Quality Management System
- ISO 13485 – Medical Device Quality Management System
- ISO 22301 – Business Continuity Management System
Technical & Quality Consultation
- DMAIC / Six Sigma Program
- Kaizen : Continuous Improvement Program
- Quality & Productivity Improvement Program
- Risk Assessment Management Program
- Safety & Health Program
- Total Quality Management
- 7 QC Tools
- SPC Control
- Failure Effect & Mode Analysis
- 8D Problem Solving
- Root Cause Analysis
- Measurement System Analysis
- ISO Gap Analysis & Auditing
- Good Manufacturing and Distribution for Medical Device
- Supervisory / Leadership Skill
Regulatory Advise & Due Diligence
Determining regulatory pathway for your product
By using regulatory advise service and due diligence service, we will assess your current situation into detail and consult it to relevant authorities.
Product Category Identification
Suppose you want to register your product but want to know the category of your product in a particular country.
Product Registration Process
Or you want to know the estimated timeline for product registration process for product launch plan.