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Your Associate for All Your Regulatory Needs for National & Global Medical Device Regulations

Alpine Quality Consultants is a trusted name in quality and regulatory consulting, dedicated to guiding medical device and IVD manufacturers through complex global compliance landscapes. We specialize in ISO 13485, EU MDR/IVDR, US FDA, CDSCO, and other country-specific regulatory systems.

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Mandatory Authorization and Registrations for Medical Devices in India

Purpose Application Registration/ License / Permission Issuing Authority

Licence to Manufacture for Sale and Distribution of Class A or Class B medical device Form MD-3 Form MD-5 SLA

Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical Form MD-4 Form MD-6 SLA

Licence to Manufacture for Sale or for Distribution of Class C or Class D Form MD-7 Form MD-9 CDSCO

Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D Form MD-8 Form MD-10 CDSCO

Licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training Form MD-12 Form MD-13 CDSCO

Import licence to import medical device Form MD-14 Form MD-15 CDSCO

Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training Form MD-16 Form MD-17 CDSCO

Lmport investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients Form MD-18 Form MD-19 CDSCO

Permission to import small quantity of medical devices for personal use Form MD-20 Form MD-21 CDSCO

Permission to conduct clinical investigation of an investigational medical device Form MD-22 Form MD-23 CDSCO + Ethics Committee

Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device Form MD-24 Form MD-25 CDSCO

Permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device Form MD-26 Form MD-27 CDSCO

Permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device Form MD-28 Form MD-29 CDSCO

Registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer Form MD-39 Form MD-40 CDSCO

Wholesale License Form MD-40 Form MD-42 SLA

Post-market Vigilance Mandatory (PV reporting) CDSCO

IVD Evaluation NA (with license) NIB

BIS Certification (where required) CRS/ ISI Mark BIS

Radiation Equipment AERB NOC AERB

Biomedical Waste Management Bio-waste Authorization SPCB/CPCB

PWM/ EWM -- CPCB

Packaging Compliance Legal Metrology (Packed Commodities) Rules, 2011 Department of Consumer affairs

IEC Code IEC Certificate DGFT

Requirement Authority Applicability

Legal Metrology (Packed Commodities) Rules, 2011 Department of Consumer affairs Devices sold in packaged form

Trademark Registration Controller General of Patent, Design and Trademarks Brand protection

Patent Filing (optional) Indian Patent Office Innovative devices

Ethics Committee Approval ICMR/CDSCO If clinical investigation is involved

GST Registration GST Council/ CBIC For commercial sale of devices

ISO 13485 Certification Voluntary but highly recommended for QMS compliance Implied need of regulator to satisfy the Schedule Fifth Requirement

AQC delivers expert technical solutions for healthcare industry needs.

Founded in 2013 by a group of visionary professionals, Alpine Quality Consultants is a leading technical consultancy service company dedicated to the Medical Devices & In Vitro Diagnostics (IVDs) industry. With a passion for quality and compliance, we provide expert solutions to ensure excellence in product development, regulatory compliance, and operational efficiency.

Mutual Respect
Client's satisfaction
Business Transparency

Committed & focused
Expert guidance
Top-tier consultancy

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Specialist Trainers for Regulatory Training

Our Amazing Services

We offer a comprehensive range of consultancy services tailored to meet the unique needs of the Medical Devices & IVDs sector

Achieve Personnel Certification Body Accreditation

MS Certification Services

Regulatory Services

Market Access

Representative Services

Trainings

Expert Services

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STRENGTH

Strength

Team Members Associated with AQC are Dynamic Industrial Professionals having rich Industrial Experience as Following Functions.

Production Planning & Control

Production (Manufacturing)

Clinical Research & Data Management

Facility Designing Consultant

QUALITY POLICY

At Alpine Quality Consultants, quality is the foundation of everything we do.

At Alpine Quality Consultants, we are committed to delivering exceptional technical consultancy services to the Medical Devices & In Vitro Diagnostics (IVDs) industry. Our mission is to support our clients in achieving regulatory compliance, product quality, and patient safety through expert guidance, innovative solutions, and a dedication to continuous improvement.

To fulfil this commitment, we adhere to the following principles:

Customer Focus

We prioritize our clients' needs by delivering tailored, high-quality solutions that ensure compliance with global regulatory requirements, including ISO 13485, FDA, IVDR, and MDR standards.

Regulatory Excellence

Our team stays at the forefront of evolving industry regulations and best practices, ensuring that our clients receive the most accurate and up-to-date guidance.

Continuous Improvement

We actively foster a culture of learning, innovation, and ongoing enhancement of our consultancy services.

Integrity & Professionalism

We uphold the highest ethical standards, maintaining transparency, confidentiality, and professionalism in all our engagements.

AQC is the perfect choice for your firm. Contact us now today!

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Why Choose AQC?

Superior Expertise: Our team comprises seasoned professionals with extensive experience in medical devices and IVD regulatory compliance.

Liasoning with the ISO/CE certification, notified bodies on matters relating to Quality Management System on behalf of company.

Proven Track Record: Over a decade of success in supporting medical device and IVD companies worldwide.

Commitment to Excellence: We uphold the highest standards of integrity, quality, and professionalism.

AQC has experienced Technical Document Writers available to write quality documents for you.

Customized Solutions: We tailor our services to align with your specific business needs.

AQC can provide templates of required documents or company specific requirement.

Full or "as needed" consulting for certification compliances.

Organizational Planning for Quality and Compliance.

GAP Analysis for Regulatory Compliance.

Competitive Pricing within the Industry.

A Cost-Effective Alternative Solution.

Proven Results with Clients.

Project Management.

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Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

Purpose	Application	Registration/ License / Permission	Issuing Authority
Licence to Manufacture for Sale and Distribution of Class A or Class B medical device	Form MD-3	Form MD-5	SLA
Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical	Form MD-4	Form MD-6	SLA
Licence to Manufacture for Sale or for Distribution of Class C or Class D	Form MD-7	Form MD-9	CDSCO
Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D	Form MD-8	Form MD-10	CDSCO
Licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training	Form MD-12	Form MD-13	CDSCO
Import licence to import medical device	Form MD-14	Form MD-15	CDSCO
Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training	Form MD-16	Form MD-17	CDSCO
Lmport investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients	Form MD-18	Form MD-19	CDSCO
Permission to import small quantity of medical devices for personal use	Form MD-20	Form MD-21	CDSCO
Permission to conduct clinical investigation of an investigational medical device	Form MD-22	Form MD-23	CDSCO + Ethics Committee
Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device	Form MD-24	Form MD-25	CDSCO
Permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device	Form MD-26	Form MD-27	CDSCO
Permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device	Form MD-28	Form MD-29	CDSCO
Registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer	Form MD-39	Form MD-40	CDSCO
Wholesale License	Form MD-40	Form MD-42	SLA
Post-market Vigilance	Mandatory (PV reporting)		CDSCO
IVD Evaluation	NA (with license)		NIB
BIS Certification (where required)	CRS/ ISI Mark		BIS
Radiation Equipment	AERB NOC		AERB
Biomedical Waste Management	Bio-waste Authorization		SPCB/CPCB
PWM/ EWM	--		CPCB
Packaging Compliance	Legal Metrology (Packed Commodities) Rules, 2011		Department of Consumer affairs
IEC Code	IEC Certificate		DGFT

Requirement	Authority	Applicability
Legal Metrology (Packed Commodities) Rules, 2011	Department of Consumer affairs	Devices sold in packaged form
Trademark Registration	Controller General of Patent, Design and Trademarks	Brand protection
Patent Filing (optional)	Indian Patent Office	Innovative devices
Ethics Committee Approval	ICMR/CDSCO	If clinical investigation is involved
GST Registration	GST Council/ CBIC	For commercial sale of devices
ISO 13485 Certification	Voluntary but highly recommended for QMS compliance	Implied need of regulator to satisfy the Schedule Fifth Requirement