MD-9 refers to the
Manufacturing License granted by the Central Licensing Authority (CLA) under
the CDSCO (Central Drugs Standard Control Organization) to manufacturers after
a successful application via Form MD-7. It grants legal authorization to manufacture
and sell Class C or D medical devices in India.
Who
Needs MD -9
Companies established in India who intend to
manufacture and sell Class C or Class D medical devices require this license.
Here’s a breakdown of the device classifications:
Class C: Moderate-Risk Devices
These are medical devices considered to have
a moderate to high risk to patients. They require stricter regulations and
controls compared to Class A and B devices. For Example:-
·
Blood
Bags
·
Catheters
·
Disposable
Perfusion Sets
·
Ablation
Devices
Class
D: High-Risk Devices
These are medical devices considered to have
the highest risk to patients. They require the most stringent regulations and
controls to ensure safety and effectiveness. For Example:-
·
Aneurysm
clip
·
Heart
Valves
·
Cortical
electrode
·
Cervical
spine immobilization head ring
Benefits
of Obtaining MD-9:
- Market Access: Enter the booming Indian medical device
market.
- Legality & Credibility: Operate legally and gain
trust with regulators and healthcare providers.
- Competitive Edge: Stand out and partner with
distributors and hospitals.
- Operational Efficiency: Manufacture and sell Class C
& D devices freely.
- Long-Term Stability: Enjoy a valid license with timely
renewals.
- Bonus: Participate in government tenders and show
commitment to patient safety.
Process
to Obtain MD-9 License:
The process for acquiring an MD-9
Manufacturing License involves following stages:
- Application (Form MD-7): Submit an application
electronically to the Central Licensing Authority through the CDSCO
portal.
- Documentation: Include required documents like:
- Cover letter
- Plant master file and device master file
- Quality Management System (QMS) documentation as per
regulations
- Performance evaluation report (for In Vitro Diagnostic
Devices – IVDs)
- Company details (constitution, ownership/tenancy
agreements)
- Valid Quality Certificate for the manufacturing site
- Valid Test License for testing and generating quality
control data
- Signed undertaking stating compliance with QMS
provisions
- Review & Inspection: CDSCO reviews the application
and conduct an inspection of the manufacturing site.
- Approval: Upon successful review of the application,
documentation, and potential inspection, the CLA grants the manufacturer a
license to manufacture and sell Class C or Class D medical devices. This
license is issued in the form of MD-9.
Validity:
The Form MD-9 license is valid indefinitely,
subject to timely payment of a license retention fee every 5 years. Non-payment
may lead to suspension or cancellation of the license.
Important
Tips:
o Ensure the manufacturing
site meets QMS requirements as per the Fifth Schedule of the Medical Device
Rules, 2017.
o Prepare device master files
and site master files according to the MDR 2017 format.
o Submit technical documents
compliant with MDR 2017 to avoid delays.
o Generate quality control
data based on a valid Test License for quicker approval.
o Upon successful review of
the application, documentation, and potential inspection, the SLA grants the manufacturer
a license to manufacture and sell Class A or Class B medical devices. This
license is issued in the form of MD-5.
Here's
why an MDR consultant is your ideal partner:
Regulatory Expertise: They’re well-versed in
the intricacies of the Medical Device Rules, 2017, ensuring your application
adheres to all requirements.
Streamlined Process: They guide you through
every step, from understanding eligibility to assembling the comprehensive
documentation package.
Accurate Documentation: MDR consultants ensure
your technical specifications, device master files, QMS documents, and other
crucial documents are complete, accurate, and formatted according to CDSCO
standards.
Effective Communication: They handle communication
with the CDSCO on your behalf, addressing any concerns and ensuring a smooth
review process.
Risk Management & QMS: They can help develop
and implement robust Risk Management and Quality Management Systems (QMS) that
meet regulatory standards, demonstrating your commitment to safety and quality.
Increased Success Rate: Their expertise helps you
avoid common pitfalls and delays, significantly increasing your chances of
obtaining the MD-9 license efficiently.
Beyond
the MD-9 Application:
MDR consultants often offer
additional services, such as:
Pre-market regulatory consulting to determine
device classification and plan your compliance strategy, Site readiness for the
Licencing audit/ final audit. MDR consultants perform stage wise internal audit
to get prepare for the final stage of audit to be conducted by the CLA,
Post-market surveillance support to monitor device performance and address
safety concerns, Regulatory compliance training for your staff.
