Quality & Compliance

Certified, licensed & compliant

Every OPTIVEIN fiber is produced under internationally recognised quality systems and full Indian regulatory licensing.

Quality Management

International QMS certification

Issued by TÜV India, accredited by NABCB. Click to view the full certificate.

Regulatory & Licensing

Fully licensed in India

We hold the following authorisations from the CDSCO and state authorities. As these documents carry licensing details, copies are shared with partners and customers on request.

CDSCO

Form MD-9 Manufacturing Licence

Licence to manufacture Class A/B medical devices, issued by CDSCO.

Held · on request
CDSCO

Free Sale Certificate

Confirms our products are freely sold in India — supporting export.

Held · on request
Regulatory

Market Standing Certificate

Attests to the product’s standing and continuity in the market.

Held · on request
Regulatory

Non-conviction Certificate

Declares a clean regulatory and legal compliance record.

Held · on request
Our Journey

Certification roadmap

From a “Make in India” start-up to a fully certified, licensed and export-ready manufacturer — year by year.

2023
Foundation

Make in India beginnings

  • May 2023Arkaya Optics established as a surgical optical fiber manufacturer under the “Make in India” initiative.
2024
Certified to manufacture

Quality & licensing secured

  • Aug 2024ISO 13485:2016 certified by TÜV India (NABCB-accredited), valid to 2027.
  • Sep 2024CDSCO Form MD-9 manufacturing licence granted.
2025
Regulatory expansion

Market-ready & export-enabled

  • Mar 2025MPCB Consent to Establish — Maharashtra Pollution Control Board.
  • Apr 2025Free Sale, Market Standing & Non-conviction certificates issued by CDSCO.
  • May 2025MD-9 product endorsement (OptiVein range) and ICMED 13485:2016 certification.
Establishment & Environment

Compliant operations

MPCB

Establishment Certificate

Maharashtra Pollution Control Board authorisation to establish & operate.

Held · on request
Product files

OptiVein Technical Datasheets

SMA & FC device specification sheets, prepared per MDSAP.

On request
Need documentation?

Request certificate copies

We’ll gladly share verified copies of our licences and certificates for your due-diligence or procurement needs.

Request documents
Our Commitment

Quality is engineered in, not inspected on

ISO 13485Certified QMS · 2016
ICMED13485 · 2016
CDSCOMD-9 licensed
100%Made in India