Compliance & Certificates

Meeting global regulatory standards for medical device excellence

At R&G BioTech Medical, compliance isn’t just about meeting requirements—it’s about exceeding them. Our comprehensive quality management system ensures every product meets the highest global standards.

Our Certifications

Globally recognized quality and compliance standards

  • CE
    CE-MDR
  • CE Rohs
    CE-RoHS Verification
  • FDA
    FDA Registration
  • ISO 9001
    ISO 9001:2015
  • ISO 13485
    ISO 13485:2016

ISO 9001:2015

Quality Management System Certification

IAF and CNAS recognized. Covers the design, development, production, and service of disposable sterile syringes with needles, disposable infusion sets with needles, and disposable dispensing syringes, plus the design and development of disposable medical and surgical masks.

ISO 13485:2016

Medical Device Quality Management System Certification

Specifically for medical devices: design, development, production, and service of disposable sterile syringes with needles, disposable infusion sets with needles, and disposable dispensing syringes, plus the design and development of disposable medical and surgical masks.

FDA Registration

U.S. FDA Registration Verification

Registered with the U.S. Food and Drug Administration. Registered products include: hypodermic single lumen needles, piston syringes, surgical apparel accessories, irrigation catheters, and single-use acupuncture needles.

CE-MDR

EU Medical Device Regulation (MDR)

We have submitted a formal application and signed a written agreement with TÜV Rheinland LGA Products GmbH, a Notified Body under EU Regulation (EU) 2017/745 (MDR), designated under NANDO number 0197.

CE-RoHS Verification

EU RoHS Compliance

Our full range of Tattoo Needle Cartridges complies with RoHS Directive 2011/65/EU and EN IEC 63000:2018.

  • For Distributors: CE-MDR certified products clear EU customs faster with zero regulatory hold-ups
  • For Tattoo Studios: Using compliant needles reduces liability risk and shows your clients you care about safety
  • For OEM Partners: Our ISO 13485 QMS and complete technical documentation make co-branding effortless

CE vs FDA: Regulatory Comparison

Understanding different compliance pathways

Regulatory Body

European Commission / Notified Bodies

US Food & Drug Administration

Classification System

Class I, IIa, IIb, III (Risk-based)

Class I, II, III (Risk-based)

Microblading Needles

Typically Class IIa

Class I / II (510(k) may be required)

Quality System

ISO 13485 required

21 CFR Part 820 (QSR)

Technical Documentation

Technical File / Design Dossier

510(k) Premarket Notification

Post-Market Surveillance

Vigilance system, PSUR

Medical Device Reporting (MDR)