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Know More About MEDICAL DEVICE (MD-42) REGISTRATION
Introduction and Its Compliance
Medical Device Registration in India is governed by the Medical Devices Rules, 2017, under the Drugs and Cosmetics Act, 1940, regulated by the Central Drugs Standard Control Organization (CDSCO). It mandates that all manufacturers and importers of specified medical devices must obtain registration/licenses to legally sell or distribute their products in India. Lawfinity supports in the classification, compilation and filing of regulatory submissions with CDSCO. We will make sure your medical device measurements meet the necessary standards no matter whether it is a diagnostic tool, an implant or a surgical instrument.
Why It Is Needed
Medical Device Registration is mandatory to ensure the safety, quality and performance of the medical devices that are distributed in India. It aids the government in controlling devices that are entering the health care system which may be not meet the basic quality standards so the public won't be put at risk. Lawfinity facilitates the full process of compliance from categorisation of devices, license grant and renewals as well.
Benefits and Advantages
- Legal Market Entry Medical Device Registration ensures that your products are legally permitted to be sold in India. It enables manufacturers and importers to tap into one of the largest healthcare markets in the world.
- Regulatory Credibility Products registered with CDSCO are seen as safe and reliable. This enhances brand image and builds confidence among healthcare professionals and end-users.
- Risk Mitigation Proper registration minimizes the risk of legal penalties, product recalls or operational disruptions. It ensures your business is protected under Indian medical regulations.
- Product Traceability & Control Registered products follow defined standards for labelling, packaging and distribution, enabling efficient monitoring, recall and accountability if needed.
- Global Expansion CDSCO registration, especially under WHO-GMP compliance, enhances credibility for export markets, boosting business growth opportunities internationally.
Eligibility Criteria
- The applicant must be a registered business entity such as a proprietorship, partnership, LLP, or private limited company.
- Must employ a qualified technical person, generally a pharmacist or science graduate with relevant experience, to supervise wholesale operations.
- The premises must comply with prescribed storage standards, including sufficient space, cleanliness, and controlled temperature/humidity if applicable.
- Application is made in Form MD-42, and the wholesale license is granted in Form MD-43.
- Applicants must ensure they deal only with medical devices that are duly registered with CDSCO.
Documents Required
- Application in Form MD-42 with prescribed government fees.
- Proof of constitution of the firm (Partnership Deed, MOA/AOA, Certificate of Incorporation).
- Identity and address proof of proprietor/partners/directors.
- Qualification and appointment letter of the technical staff supervising sales.
- Property ownership/lease agreement and site plan of storage premises.
- Proof of adequate storage infrastructure (temperature monitoring, racks, refrigeration if needed).
- Undertaking to maintain records of purchase and sale of devices.
- Copy of GST registration and PAN of the business entity.
- Fees payment receipt as per device category
- Any additional documents as required by the State Licensing Authority.
Steps
- Preparation: Confirm eligibility, appoint qualified technical staff, and ensure premises meet regulatory requirements.
- Application Filing: Submit Form MD-42 with documents and applicable fees to the State Licensing Authority.
- Document Scrutiny: Authority reviews documents for accuracy and completeness.
- Inspection: Premises inspection may be conducted to verify compliance with storage and record-keeping norms.
- Deficiency Resolution: Any deficiencies pointed out must be addressed within the given timeframe.
- Grant of License: Wholesale license is issued in Form MD-43, authorizing the applicant to stock and distribute medical devices.
Penalties
- Sale of unregistered or misbranded devices may result in product seizure, license cancellation, or blacklisting.
- Wholesalers operating without Form MD-43 license may face imprisonment up to 5 years and fines starting from ₹1,00,000 or three times the value of confiscated goods.
- Non-compliance with labelling, packaging, or record-keeping obligations can invite suspensions or additional penalties.
- Repeated violations may permanently bar a wholesaler from operating in the medical device sector.
Timelines
Form MD-42 Applications
Typically processed within 30 to 60 working days, depending on the State Licensing Authority’s workload.
Extended Timelines
Timelines may extend if inspection reports highlight deficiencies or if documents require re-submission.
Our services include guidance, documentation support, and application facilitation. It is important to note that we are not a government department, not a government-run website, and not affiliated with any government authority in any capacity. The role of lawfinity.in is purely that of a professional consultant.
Fee
Frequently Asked Questions
Because every great business starts with the right answers.
Yes, any business dealing in stocking, distribution, or sale of notified medical devices must obtain a wholesale license.
The State Licensing Authority (SLA) of the respective state.
Applications are filed in Form MD-42, and the license is granted in Form MD-43.
Usually valid for five years, subject to payment of retention fees and compliance with conditions.
Yes, a qualified technical person with a degree/diploma in pharmacy or relevant science discipline is mandatory.
Yes, provided all devices are duly registered with CDSCO and records are properly maintained.
No, they apply to the State Licensing Authority, but they must ensure that the products they handle are CDSCO-approved.
Generally, a fresh application is required, but certain states allow modifications if there is no change in premises or technical staff.
Yes, most states conduct inspections before granting a wholesale license.
Yes, Lawfinity assists with renewals, amendments, compliance audits, and handling regulatory inspections.
Voices of Success
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Anil Yadav
Shaperz India Grain Private Limited
“From FSSAI to Trade License, Lawfinity handled all our approvals efficiently. One-stop solution for all licensing needs.”
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