Overview
Obtaining a registration certificate is mandatory for any individual or organization intending to sell, stock, or distribute medical devices in India, including In Vitro Diagnostics (IVDs). This certificate, issued by the State Licensing Authority (SLA), ensures legal compliance, proper storage, and safe handling of medical devices.
The recent notification from the Department of Health and Family Welfare provides detailed guidance on eligibility, application procedures, required documents, and validity of the certificate.
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Who Needs a Registration Certificate
Any person or entity not holding a manufacturing license under sub-rule (1) and planning to sell, stock, or distribute medical devices must obtain a registration certificate. This ensures legal authorization to operate and compliance with safety and quality standards.
Eligibility Requirements for Competent Technical Staff
The notification mandates that the competent technical staff:
- Should be a graduate from a recognized university, or
- Be a registered pharmacist, or
- Have passed an intermediate examination (or equivalent) with at least one year of experience in selling or distributing medical devices.
Documents Required for Registration Certificate Application
Applicants must submit:
- Self-certificates of compliance
- Documentary evidence of ownership or rental premises
- Any other supporting documentation as required by the SLA
Application Process and Timelines
- Submit the application using Form MD-41 to the SLA.
- SLA will review and accept or reject the application within 10 days.
- In case of rejection, an appeal can be filed within 45 days.
Forms and Records for Compliance
- Registration Certificate is issued in Form MD-42.
- Inspection records must be maintained in Form MD-43.
- Separate records for all activities must be kept and made available for inspection by a medical device officer.
Storage and Handling Requirements
- Adequate storage space must be provided for medical devices.
- Proper environmental conditions must be maintained to ensure safety and integrity.
- Medical devices must only be purchased from importers, licensed manufacturers, or registered entities.
Validity and Renewal of Registration Certificate
- The certificate is valid for 5 years unless suspended or canceled by the SLA.
- Forms MD-14, MD-15, MD-26, and MD-28 now reflect the updated language “or registration certificate” after “manufacturing license.”a
Need Help Getting Your Registration Certificate Fast & Compliant?
Role of Operon Strategist in Registration Certificate Process
At Operon Strategist, we guide clients through the entire registration certificate process, ensuring fast and compliant approvals. Our services include:
- Assistance with documentation and SLA submission
- Guidance on storage, record keeping, and competent technical staff compliance
- Updates on regulatory changes so no deadline is missed
We also provide consulting for other critical services:
- Turnkey Project Consultants for Medical Devices
- Medical Device Manufacturing Facility Setup
- FDA 510(k) Consulting
- CE Marking Consulting
With our expertise, manufacturers and distributors can achieve fast, risk-free market access while staying fully compliant.
Download the Official Notification on Registration Certificate
FAQs
What is a registration certificate for medical devices in India?
A registration certificate is an authorization issued by the State Licensing Authority (SLA) that allows a person or entity to legally sell, stock, exhibit, or distribute medical devices and IVDs in India. It applies to distributors who do not hold a manufacturing license and ensures compliance with CDSCO medical device rules.
Who is required to obtain a registration certificate?
Any individual, wholesaler, retailer, or distributor intending to sell or distribute medical devices—including IVDs—must obtain a registration certificate, unless they already hold a valid manufacturing license under the Medical Devices Rules, 2017.
Which form is used to apply for a registration certificate?
The application for a registration certificate must be submitted to the State Licensing Authority using Form MD-41. Once approved, the certificate is issued in Form MD-42.
What qualifications are required for a competent technical person?
The competent technical person must be:
A graduate from a recognized university, or
A registered pharmacist, or
An intermediate pass (or equivalent) with at least one year of experience in the sale or distribution of medical devices.
How long does it take to get a registration certificate?
The State Licensing Authority generally takes up to 10 working days to accept or reject the application after submission. If rejected, the applicant may file an appeal within 45 days from the date of rejection.
