Medical device registration is a mandatory registration for businesses dealing with all sorts of medical devices such as X-ray Maachine , Thermometers, Syringes and catheters, pacemakers and several test kits. 

Any person manufacturing, selling, importing and testing any type of medical devices must apply for medical device product registration.

WHAT ARE MEDICAL DEVICES?

Devices which are used in medical treatments and diagnostics are known as medical devices such as surgical dressings, bandages, syringes, sutures, ligatures, and blood collection bags, which may or may not contain anticoagulants.

Additionally, mechanical contraceptives like condoms, intrauterine devices (IUD covered under the definition of medical devices.

DIFFERENT CLASSES OF MEDICAL DEVICES

Medical devices span from simple bandages to high-level surgical tools and many others. Global regulatory authorities classify these devices according to risk level, in order to guarantee safety and effectiveness. This designation helps to expedite the review and regulatory access.

 

Class I Devices (Low Risk)

Bandages, surgical gloves, and stethoscopes are examples of Class I devices. These devices are typically low-risk and are not capable to harm majorly to the patient. Since low risk is associated, they are easy to acquire.

 

Class II Devices (Moderate Risk)

Moderate-risk devices, such as infusion pumps and blood pressure monitors, are subject to more stringent regulatory controls than Class I products. For moderate-risk categories, such as 510(k) or PMA (Pre-Market Approval), performance data must be provided before authorization of sale.

 

Class III Devices (High Risk)

Class III devices are usually designed which have roles in either maintain or supporting life. Examples are pacemakers, ventilators, and heart valves.

These items are strictly regulated and includes clinical trials and thorough safety assessments. Department ensures that they are safe to be used as medical device before granting license.

 

Class IV Devices (High-Impact Devices)

Class IV medical devices poses the highest potential impact on patient health, such as implantable defibrillators. These devices undergo strictest safety guidelines. Authorities keep checks on Class IV Medical devices so that it can never harm any patient and only devices which are safest should reach in the market.

TYPES OF MEDICAL DEVICE REGISTRATION

MEDICAL DEVICE REGISTRATION FOR MANUFACTURING

Medical Device manufacturing license is categorized into different classes based on risk, and the guidelines are prescribed as per the different classes of medical devices. Devices listed as Class A and B have lower-risk while Class C and D are considered higher-risk which requires more strict approval process.

Class A and Class B Medical Devices

  • For manufacturing Class A and Class B medical devices, there are specific applications and licensing procedures:
  • Application MD-3 is for manufacturing Class A and Class B medical devices and License get generated in form MD-5.
  • Application MD-4 is for third-party (loan) manufacturing of Class A and B devices and License gets generated in form MD-6
  • The State Licensing Authority of the the respective states (SLA) is responsible for accepting and issuance of these medical devices license. License approvals within a timeline of 45 days.
Inspection:
  • Class A devices do not require an inspection before the license is granted. After issue of license notified body will conduct an inspection within 120 days.
  • Class B devices require an inspection by a notified body before the license is granted. This inspection is done within 90 days, and the report is submitted within 30 day to the SLA

Class C and Class D Medical Devices

  • Class C and D devices, being higher-risk, follow a more rigorous process.
  • Application MD-7 is for manufacturing Class C and D medical devices, leading to a License MD-9.
  • Application MD-8 is for third-party (loan) manufacturing of Class C and D devices, resulting in a License MD-10.
  • The Central Licensing Authority (CLA) issues licenses for these classes. An expert team, appointed by the CLA inspect the premises before the license is granted. Inspection is done within 60 days of making the application.
  • For Class C and D devices, manufacturers must comply with the Quality Management System prescribed under the law. If the application is for a loan license, no inspection is required.
Technical Staff Requirements for Class C & D:
First Competent Technical Person:

Must have either a degree in engineering, pharmacy, or a related science with at least two years of experience in manufacturing or testing medical devices, or

A diploma in a relevant field with four years of experience.

 
Second Competent Technical Person:

Must have a degree or diploma in a relevant field and at least two years of experience in testing medical devices. This individual supervises the testing activities.

License Validity and Fees

Licenses are valid for five years initially. Thereafter license holder will pay rentention fees before the license gets expired.

If the fee is delayed, a 20% late fee per month applies for up to six months. If you fail to pay within six months then license will be cancelled.

Summary:

Manufacturing medical devices is classified into Class A, B, C, and D, with each class having different guidelines for approval . For Class A, no inspection is needed before the license, while Class B needs one before the license is granted. Class C and D devices need a strict inspection and require experienced technical staff. Licenses are valid for five years and need a yearly fee to be renewed.

MEDICAL DEVICE REGISTRATION FOR IMPORT :

The process for getting an import license for medical devices involves strict regulations and guidelines which can be referred from CDSCO website. Person applying for import license must follow these guidelines before applying for the license.

Applicants  have to submit Form MD-14 on CDSCO portal with the required fee which is given below and mandatory documents

Central Licensing Authority is the competent authority to issue import license for medical devices

INSPECTION OF MANUFACTURING SITES

The Central Licensing Authority may inspect overseas manufacturing sites before granting an import license. Inspections can be conducted either by the authority or delegated bodies.

Applicants have to pay for inspection costs.

GRANT OF LICENSE

After CLA verifies the documents and inspect the premises then may grant the license in Form MD-15 within nine months or reject the application if any application is found with major deefects and no response is submitted for the querries issued from the department.

In case application is rejected, then applicants can appeal to the Central Government, which will issue the appropriate order within 90 days after vetting the case.

VALIDITY AND RENEWAL

Licenses are valid for lifetime, provided applicant pays the retention fee every five years.

A late fee of 2% per month applies if payment is delayed but made within 90 days. Failure to pay within this period results in automatic cancellation of the license.

FEES

TABLE

MEDICAL DEVICE LICENSE FOR SALE

According to the rules the guidelines for selling medical devices will follow the same rules set for the sale of drugs under Part VI of the Drugs and Cosmetics Rules of 1945. This means that if you have a valid Retail or Wholesale drug license then it will considered as you have license to sell medical device also according to rule 87 of the Medical Device Rules,2017.

 

Also MD-42 license can be applied for wholesale of medical devices.

What is medical device registration?

Medical device registration involves legal authorization of devices in the market that can be used safely, which is of good quality and effective. It includes, an extent of classification, level of quality compliance, documentation, integrating clinical evaluation and finally surveillance all of which are required by authorities to ensure that patients health and safety is protected.

Which license is required for medical devices?

In India any medical devices are required to be registered and licenced under the central drugs standard control organisation (CDSCO) as per the medical devices rules of 2017. Required licenses and approvals include:

Manufacturing License: It is a type of license which is mandatory for any manufacturer of medical devices and it can be given by either the state licensing authority or by CDSCO based on the classification of the device. Exactly MD – 5 & 6 are for manufacturing license for subclasses of class A & B the same as MD-8 & MD -9 which is for class C & D device likewise is MD – 10 for loan manufacturing license.

Import License: It is a license which is essential for any company that is importing any medical device into India and this is also issued by CDSCO. The application usually includes class of the device, documentation, quality and, where relevant, regulatory approvals from outside the country.

Registration Certificate: This is required for those devices which have been classified in certain categories as notified categories for a device registration a CDSCO is essential prior to commencement of marketing of the device.

Also MD-42 license is applied for for selling medical devices on wholesale basis.

What is MD 15 form?

India is among those countries where The MD-15 license, supplied by CDSCO, authorizes importation of medical devices. It is a requirement for applicants to have wholesale licenses (Form 20/21B) or registration (Form 41/42). This is valid up to five years.

What is form MD 42?

In India, there is a State Licensing Authority that issues the MD-42 license to be retailers, wholesalers, or stockists in selling or distributing medical devices. This license is always valid but requires periodic fees, an application in form MD-41 is required, excludes those engaged in manufacturing or wholesale licensing.

How to get a CDSCO license?

For getting a CDSCO license, these are the processes to follow:

·         Go to the CDSCO registration portal.

·         Click Login/Sign Up and choose Sign Up Here.

·         Indicate the purpose of registration.

·         Fill in the Applicant Registration form.

·         Attach necessary proof of identity and an undertaking.

·         Obtain the Indian Address of the Registered Applicant form.

·         Obtain proof of the corporate address as necessary.

·         Use the application form and enter the details.

·         You’ll receive a link to your email for verification so do this.

What is a MD-13 license?

Form MD 13 is a Test License which authorizes the manufacture of research devices on a medical device for India. Clinical research: development: testing: evaluation; demonstration; clinical trial training In brief.

 It is issued by the Central Drugs Standard Control Organization (CDSCO) which has a validity of 3 years.

What is form MD 14?

Form MD-14 is a type of application for medical device import license available from India’s Central Drugs Standards Control Organization (CDSCO) in terms of A-D classes coverage and medical devices import licenses.

How do I register a medical device in India?

  • Register on SUGAM Portal: Go to SUGAM, register with a valid email and mobile number, and verify using the OTP.
  • Submit Application: Log in to submit Form MD-14 (for Class A/B) or Form MD-15 (for Class C/D), along with DMF, PMF, clinical data, QMS certification, and device details (generic name, brand, intended use, model numbers).
  • Send Hard Copy & Review: Submit a hard copy to CDSCO (Medical Device Division) for review. CDSCO may inspect manufacturing facilities for compliance with regulatory and Good Manufacturing Practices (GMP) standards.

What happens if a medical device is not registered?

If a medical device is not registered, it cannot legally be sold or distributed in most markets. Additionally, manufacturers may face penalties, including fines or product recalls.

How long is a medical device registration valid?

The validity of a medical device registration varies by country but typically ranges from 3 to 5 years, after which re-certification may be required.

Do all medical devices need clinical trials for approval?

Not all medical devices require clinical trials. However, higher-risk devices (Class II and III) often need clinical data to demonstrate safety and effectiveness.

Expert opinion

In order to receive the medical device registration without any delay and with no difficulties medical device license application should be filed keeping in view of all rules and regulations prescribed for any particular medical devices. For Instance, Application for wholesale license must be applied in application MD-41, and all technical details related to the device must be attached while submitting the application.