MD-5 refers to the Manufacturing License granted by the State
Licensing Authority (SLA) under the CDSCO (Central Drugs Standard Control
Organisation) to manufacturers for producing and selling Class A or
Class B medical devices (including In Vitro Diagnostic Devices – IVDs)
within India.
Who Needs MD -5
Companies established in India who intend to manufacture and
sell Class A or Class B medical devices require this license. Here’s a
breakdown of the device classifications:
·
Class
A Devices: These are
considered low-risk medical devices, such as:
o
Bandages
o
Tongue depressors
o
Surgical drapes
·
Class
B Devices: These are
categorized as low-to-moderate risk devices, including:
o
Stethoscopes
o
Syringes
o
Surgical instruments
Benefits
of Obtaining MD-5:
- Market
Access: It allows you to
participate in the growing Indian medical device market.
- Legal
Authorization: MD-5 grants legal
permission to manufacture and sell Class A or Class B medical devices in
India.
- Credibility: Having a CDSCO-approved manufacturing license
enhances your company’s reputation in the Indian market.
Process
to Obtain MD-5 License:
The process for acquiring an MD-5 Manufacturing License involves
following stages:
1. Application:
The manufacturer submits an online application
on the CDSCO portal using Form MD-3. This form captures details
about:
1.
The company
2.
Manufacturing facility
3.
Proposed medical
devices (Class A or Class B)
4.
Responsible personnel
within the company
2. Documentation:
Along with Form MD-3, the manufacturer needs
to submit various documents proving compliance with the Medical Device Rules,
2017. These may include:
·
Company registration
documents
·
Manufacturing facility
layout plans
·
Quality Management
System (QMS) documentation (demonstrating adherence to ISO 13485 is highly
recommended)
·
Technical
specifications and design dossiers for the medical devices
·
Labelling information
3. Inspection:
The CDSCO may conduct an inspection of the
manufacturing facility to verify compliance with the regulations.
4. Approval:
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.
5. Validity:
The MD-5 Manufacturing License is generally
considered valid permanently. However, the manufacturer needs to
pay a license retention fee periodically (every five years) to maintain its
validity.
The Role of MDR
Consultants:
·
Expertise
in CDSCO Regulations: MDR consultants
possess in-depth knowledge of the Medical Device Rules, 2017, and can guide you
through the entire licensing process.
·
Documentation
Preparation: They can assist
you in preparing the necessary documentation according to CDSCO requirements,
saving you time and effort.
·
Communication
with Authorities: MDR consultants
can effectively communicate with the CDSCO and State Licensing Authority on
your behalf, addressing any queries or concerns they may have.
·
Risk
Management and Quality Management Systems: They can help you develop and implement robust Risk
Management and Quality Management Systems (QMS) that comply with regulatory
standards.
o
Obtaining an MD-5
license can be a complex process with intricate regulations. MDR (Medical
Device Regulation) consultants can play a vital role in ensuring a smooth and
successful application process. Here’s how they can help:
· Increased Success Rate: By leveraging their expertise, you can significantly increase your chances of obtaining the MD-5 license efficiently.
