Snapshot

Why AMTZ (Vizag) is iconic:
The Andhra Pradesh MedTech Zone (AMTZ) in Visakhapatnam is India’s first and largest integrated medical devices manufacturing park. Established over 270+ acres, AMTZ is a government-supported initiative to make India self-reliant in medical devices manufacturing. The park houses over 100 companies, providing end-to-end infrastructure including R&D labs, prototyping centers, regulatory facilities, and high-end testing equipment.

Industrial edge:

• Offers plug-and-play facilities for startups, SMEs, and global medtech giants.
  
• Centralized shared services like MRI/CT calibration labs, sterilization, 3D printing, and regulatory support reduce manufacturing costs.
  
• Acts as a “one-stop solution” for innovation, testing, manufacturing, and exports.
  

Scale: Over 100+ medtech companies and 50+ specialized testing labs, serving diagnostics, imaging, consumables, and life sciences industries.

Product Range

Category	Key Products
Medical Devices	Syringes, needles, stents, implants, orthopaedic devices
Diagnostics Equipment	Blood analyzers, hematology systems, diagnostic kits
Imaging Systems	MRI, CT, ultrasound, digital X-ray, radiology components
Critical Care Equipment	Ventilators, oxygen concentrators, infusion pumps
Consumables & Disposables	Catheters, surgical gloves, masks, wound care
High-End Electronics	PCB modules, sensors, IoT-enabled devices
Custom Solutions	Product development & contract manufacturing (CDMO/ODM)

Cluster Strengths

Feature	Details
Largest Integrated Park in India	Spread over 270+ acres, specialized exclusively for medical devices
Shared Services Ecosystem	Testing, calibration, sterilization, packaging, R&D support
R&D and Innovation Hubs	Centres for 3D printing, electronics prototyping, and medical-grade materials
Export-Focused	SEZ units for global medical device markets
Government Support	Backed by Govt. of India & Andhra Pradesh Industrial Infrastructure Corporation
Start-up & SME Friendly	Dedicated incubation centers, subsidized rentals, plug-and-play modules

Materials & Sustainability

Key Materials: Medical-grade polymers (PP, ABS, PVC, silicone), stainless steel, titanium, bio-compatible alloys, PCB assemblies, medical electronics.

Sustainability Edge:

• ISO 14001-certified, green manufacturing park with solar power integration
  
• Centralized waste treatment and sterilization facilities
  
• Eco-friendly packaging solutions and reusable device R&D initiatives
  
• Focus on import substitution, reducing India’s medical device import dependency
  

Cluster Infrastructure

• Testing & R&D Labs:
  
  • MRI/CT calibration & testing lab
    
  • Radiological equipment evaluation center
    
  • Electromagnetic Compatibility (EMC) and EMI labs
    
  • Sterilization and biocompatibility testing centers
    
• Manufacturing Facilities:
  
  • Cleanroom-enabled plug-and-play factories
    
  • Tooling and injection molding facilities
    
  • IoT-enabled production lines
    
• Institutions & Support:
  
  • MedTech Skill Development Center
    
  • National Medical Device Regulatory Support Unit (NMRU)
    
  • Collaboration with IITs, NITs, AIIMS for clinical validation
    
• Connectivity:
  
  • Visakhapatnam Port (20 km) and International Airport (15 km)
    
  • Road and rail connectivity via NH-16 along the Golden Quadrilateral
    

Compliance & Certifications

• ISO 13485 (Medical Devices QMS), ISO 9001, ISO 14001, OHSAS 18001
  
• CE, FDA, and TGA certification facilitation for global market access
  
• NABL-accredited labs for pre-clinical, calibration, and biocompatibility testing
  
• CDSCO registration and DCGI approvals under India’s Medical Device Rules
  
• UDI (Unique Device Identification) support per EU/USFDA standards
  

Production Timelines & MOQs

Product Type	Sampling Lead Time	Bulk Lead Time	MOQ Guidance
Disposables (Syringes, Gloves)	1–2 weeks	3–5 weeks	50,000+ pcs per SKU
Diagnostic Equipment	3 weeks	6–8 weeks	100–500 units
Imaging Systems (MRI/CT)	4–6 weeks	8–12 weeks	Project-based
Ventilators & Critical Care Kits	3–4 weeks	6–8 weeks	200+ units
PCB & Electronics Modules	2–3 weeks	4–6 weeks	5,000+ modules

Branding & Packaging

• Branding: Laser-etched UDI codes, GS1 serialization, private-label branding options
  
• Packaging:
  
  • Sterile barrier packaging, vacuum-sealed pouches
    
  • Shock-proof crates for imaging and diagnostic equipment
    
  • ISPM-15 compliant pallets for export
    
  • Temperature-controlled packaging for sensitive devices
    

Quality Control (IndiaUnbox Protocol)

• Biocompatibility and ISO 10993 testing for medical-grade materials
  
• EMC/EMI compliance testing for electronics
  
• Sterility validation and ISO 11135/ISO 11137 compliance
  
• Process validation with batch traceability and CoA for each lot
  
• Third-party audits (SGS, TÜV, Intertek) for export shipments
  

Price Drivers

• High precision manufacturing and cleanroom requirements
  
• Certification and clinical validation costs for global markets
  
• Import content of sensors, semiconductors, and specialized materials
  
• Packaging and temperature-control logistics for exports
  
• Economies of scale from shared services within AMTZ
  

Buyer Confidence Signals

• AMTZ is India’s only integrated medtech park, reducing device manufacturing costs by up to 40%.
  
• Over 100+ companies operational, including Siemens, GE Healthcare suppliers, and homegrown innovators.
  
• Backed by Govt. of India and WHO-collaborating centers, ensuring regulatory alignment.
  
• Preferred destination for diagnostics, imaging, and disposable devices manufacturing in South Asia.
  
• SEZ and plug-and-play ecosystem enables fast-track exports to 70+ countries.