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Read more →CDSCO Medical Device Registration
CDSCO Registration or Medical Device Registration in India is based on the Medical Devices Rules, 2017, which are according to the Drugs and Cosmetics Act, 1940. It is managed by the Central Drugs Standard Control Organisation (CDSCO). It provides that all manufacturers and importers of certain medical devices need to be registered/licensed before being able to market their product in India.
Infinix Legal offers the categorisation and compilation of submissions for CDSCO registration. You can be assured that your device will be calibrated to the required standards regardless of whether it is a diagnostic machine, an implant, or surgical equipment.
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What Is Medical Device Registration?
Medical devices are those devices that prevent, diagnose, treat, or monitor a medical condition or disease. They do not function chemically as drugs do. They function physically. They include syringes, pacemakers, blood pressure monitors, stents, orthopaedic devices, X-ray machines, and surgical equipment. In order to ensure patient safety, all medical devices must be approved before manufacture or sale within the nation’s borders. Registration of the licence of a medical device in India is extremely important because, through it, safety and effectiveness are ensured in the usage of these medical devices. Registration of medical devices means getting permission from the CDSCO to make, import, or sell the medical device in India. This is a way of proving that the medical device is both safe and effective for use. Without the registration, making and selling medical devices in India is considered an offence. Registration of medical devices is not just important but also a necessity. It is a way of protecting the public, gaining public trust, and avoiding legal sanctions for the company in the Indian market.Call us to hire an CDSCO medical device registration consultant.
Why Medical Device Registration 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 not meet the basic quality standards, so the public won't be put at risk.
The long, confusing medical device licence registration process can be frustrating if you are new to Govt websites. Seek help from our CDSCO import license consultants to import a license to apply for medical device registration online.
Benefits Of Medical Device Registration in India
Legal Route to Enter the Market
The Medical Devices Registration allows for your devices to be legally sold in India.Building Your Name
Since the devices will be pre-approved by CDSCO, your devices will always be trusted. This helps you build your name without much effort on your part.Mitigating Risks
There are no risks of facing any legal action or having to recall your product. This way, your business will be covered under India’s healthcare laws.Product Tracking & Control
With the registered products, you will be assured of having set standards when it comes to labelling, packing, and shipping.Global Expansion
Registration with CDSCO, especially through WHO GMP, increases credibility within the export market, thereby generating business opportunities abroad.Eligibility Criteria For Medical Device Registration
- The individual should be registered as a business entity like proprietorship, partnership, LLP, or Private Limited Company.
- Should have a qualified technical individual, who could be a pharmacist or any graduate from the sciences, with some experience.
- The premises should meet storage standards required, which include sufficient space, sanitation, and temperature/ humidity control as necessary.
- The license application should be done on Form MD-42, while the wholesale license will be issued on Form MD-43.
- Applicants need to ensure that they are handling the medical devices as per their registration from CDSCO.
Documents Required For Medical Device Registration
- Application in Form MD-42 along with prescribed charges.
- Proof of formation of the company (Partnership Deed, MOA/AOA, Certificate of Incorporation).
- Proof of identity and address of the proprietors/partners/directors.
- Qualifications and appointment letters of technical personnel managing the sales.
- Proof of property/leasing of a place for storage, along with its map.
- Proof of proper storage facilities (Temperature Control, Storage Racks, Refrigeration facility as applicable).
- Undertaking of accounts regarding the purchases and sales of the equipment.
- Certificate of GST Registration along with PAN Card of the entity.
- Proof of Fees payment as per the Category of Devices.
- Any other document as required by the State Licensing Authority.
How to register a CDSCO Medical Device Registration in India?
Preparation Requirements
Ensure that your business qualifies for licensing, employs adequate technical personnel, and is in compliance with all applicable laws.Application Procedure
Fill in form MD-42 together with other supporting documents and fees to the state licensing authority.Document Examination Procedure
Your document examination will be carried out by the authority.Inspection Procedure
Inspections can be done at your place to ascertain whether you qualify under storage requirements and record-keeping requirements.Deficiency Rectification
Any deficiency pointed out to you needs to be corrected within the prescribed time limit.Wholesale License
This wholesale license is issued under the MD-43 form which authorises the storage and distribution of medical devices.Call us now to avail our medical device import licence.
Medical Device Registration Cost in India
India's medical device registration fees under CDSCO vary depending on the risk level (A-D Class) of the devices, where the fees range between ₹4,165 and more than ₹2.4 lakh per device/location. The major fees are $1,500 (approximately ₹1.25 lakh) for the manufacture registration and 1,000 (about ₹83,000) for individual device importation.Penalties
| Unregistered or misbranded equipment is subject to confiscation, loss of licenses, or banning. |
| A wholesaler who doesn't have a Form MD-43 license shall be punished with a prison term for up to 5 years, along with monetary fines ranging from ₹1,00,000 to thrice the value of seized equipment. |
| A violator may be banned from participating in any business related to the medical equipment industry for life. |
Timelines
Processing Form MD-42 Applications
Takes 30 to 60 days, depending on the workload of the State Licensing Authority.Extended Timeline
May take longer than normal when the inspection report contains any deficiency in the documents submitted.Why Choose Us?
Legal Infinix provides the best medical device registration service to all clients through the help of our professional consultants. Get your Query registered with us, and our expert consultant will connect with you soon and clear all your doubts about Medical device registration. We have been in this business of helping clients in their legal matters for a long time.
Choose Legal Infinix, your trusted and reliable Legal associate, to save your growing business from any legal hurdle.
Other Services from Legal Infinix
We manage complete business setup and compliance across India.
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