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The CDSCO (Central Drugs Standard Control Organization) uses the SUGAM Portal as its online e-governance platform to manage the registration process for medical devices.
The voluntary registration period that started on October 1 2023 ended because now all medical devices which include Class A Class B Class C and Class D devices must obtain registration or licensing before they can enter the Indian market.
The portal is designed as a “Single Window” interface. Depending on your business, you must register under one of these roles:
In the context of the Medical Devices Rules (2017) in India, MD-12 and MD-13 are regulatory forms used to obtain a “Test License” for medical devices.
While these terms are also famously associated with a historic “Super Jumbo” aircraft project, they are most used today in the medical regulatory field.
The Central Drugs Standard Control Organization (CDSCO) permits manufacturers to create medical devices in small quantities through these forms which cover Classes A B C and D devices used for tests clinical trials and demonstrations.
Incontext of the Me the dical Devices Rules (2017) in India, MD-16 and MD-17 are the “Import” equivalents of the MD-12/13 forms you previously asked about.
While MD-12/13 are for domestic manufacturing of test batches, MD-16/17 are specifically for the import of medical devices into India for non-commercial purposes.
The forms are required when companies want to import small amounts of medical devices which belong to Classes A B C and D from other countries to test train and conduct clinical trials in India.
You would use MD-16/17 if you are:
In the Indian regulatory landscape, Form 12 and Form 11 are the traditional versions of the “Test License” forms specifically for Drugs
The purpose of this process is to import drugs which will be used for examination testing and analysis and clinical trials.
The test site information requires you to provide drug name and quantity and foreign manufacturer source details.
The application process is used by importers and pharmaceutical companies and research institutions.
Form 11 is the actual Test License issued by the CDSCO (Central Drugs Standard Control Organization) once the Form 12 application is approved.
In the Indian pharmaceutical and medical regulatory system, Form 30 and Form 29 are the “Manufacturing” counterparts to the import forms (Form 12/11) we discussed.
Form 30: The Application
The State Licensing Authority (State FDA) receives Form 30 which serves as the application that manufacturers submit to the authority.
Purpose: To request permission to manufacture small quantities of a drug for “examination, test, or analysis.”
Before launching a new medicine a company needs to create “test batches” for testing stability and conducting laboratory analyses and performing clinical trials.
Form 29 is the actual Test License issued by the State Licensing Authority.
MD-3/5-
under the Medical Devices Rules (2017), MD-3 and MD-5 are the critical forms for the commercial manufacturing of low-to-moderate risk medical devices.
Form MD-3 is the application a manufacturer submits to the State Licensing Authority (SLA).
Form MD-5 is the actual Manufacturing License granted by the State Licensing Authority.
|
Device Class
|
Risk Level
|
Application Form
|
Issued License
|
Authority
|
Class A & B |
Low to Moderate |
MD-3 |
MD-5 |
State (SLA) |
|---|
To get your MD-5 license, you typically need to provide:
In the Indian regulatory framework under the Medical Devices Rules (2017), MD-4 and MD-6 are the “Loan License” versions of the MD-3/5 manufacturing forms.
While MD-3/5 is for companies that own their factory, MD-4/6 is for companies that want to manufacture products at someone else’s licensed facility.
The “Loan Licensee” files their application through Form MD-4 to the State Licensing Authority (SLA).
The purpose of this request is to obtain permission for manufacturing Class A and Class B medical devices which will be produced at another manufacturer’s facility.
The purpose of this request is to obtain permission for manufacturing Class A and Class B medical devices which will be produced at another manufacturer’s facility.
The service is utilized by startups and small businesses and foreign companies which prefer not to build their own factory but wish to sell medical devices under their own brand.
Form MD-6 is the actual Loan License issued to the applicant.
|
Type of License
|
Application Form
|
Issued License
|
Who is it for?
|
|---|---|---|---|
|
Own Manufacturing |
MD-3 |
MD-5 |
Companies with their own factory. |
|
Loan Manufacturing |
MD-4 |
MD-6 |
Companies outsourcing production. |
MD-7 and MD-9 are the high-stakes versions of the manufacturing licenses.
The MD-3/5 series identifies low-risk items while MD-7 and MD-9 handle high-risk medical devices which include heart stents and pacemakers and bone plates. The devices require more intense examination because they present greater danger to users.
The manufacturer needs to submit Form MD-7 to request a license that allows them to produce high-risk devices for commercial distribution.
Form MD-9 is the actual Manufacturing License granted by the Central Licensing Authority.
|
Risk Class
|
Device Example
|
Application
|
License Issued
|
Who Approves?
|
|---|---|---|---|---|
|
Class A & B |
Gauze, Thermometer |
MD-3 |
MD-5 |
State FDA |
|
Class C & D |
Stents, Ventilators |
MD-7 |
MD-9 |
Central CDSCO |
MD-8 & MD-10: Loan License for High-Risk Medical Devices
If you are a startup, a research-based firm, or an importer looking to manufacture Class C (Moderate-High Risk) or Class D (High Risk) medical devices in India using a third-party facility, the MD-8/10 pathway is your regulatory solution.
This license is designed for:
Form 24 and Form 25 are the primary documents for manufacturing Allopathic drugs.
While the “MD” forms you asked about earlier are for Medical Devices, the “Form 24/25” series is governed by the Drugs and Cosmetics Rules, 1945 and applies to medicines like tablets, capsules, and ointments.
The application for a drug manufacturing license requires submission of Form 24 to the State Licensing Authority. The drug approval process applies to drugs which are not included in Schedule C and Schedule C(1) and Schedule X.
Form 25 is the actual Manufacturing License issued by the State Drug Controller.
Drug Manufacturing (Pharmacy)
The pharmaceutical industry uses these forms as their standard method of obtaining licenses:
MD 41/42-
MD-41 and MD-42 are the official documents required for the sale and distribution of medical devices (including IVDs).
This system was introduced as a simpler alternative to the traditional drug wholesale licenses (Forms 20B/21B) to better regulate the medical device supply chain.
Any person or business entity involved in the commercial trade of medical devices in India must have an MD-42 license. This includes:
The Indian medical and pharmaceutical industry uses Form 20 and Form 21 as its main regulatory instruments for controlling drug distribution. The Drugs and Cosmetics Act (1940) requires all organizations that intend to sell or distribute medicinal products to obtain these documents.
Most medical shops (pharmacies) hold both licenses simultaneously because together they allow the sale of almost all common medicines.
To obtain these licenses from the State Licensing Authority (SLA) you need to fulfill all the required criteria.
The Indian pharmaceutical industry requires wholesale drug distributors to obtain both Form 20B and Form 21B as their necessary licensing requirements.
The standard Form 20 and 21 provide retail licenses to sell medical products directly to patients. The “B” suffix of these forms designates a wholesale license which permits sales to hospitals pharmacies and other distributors.
You must obtain these licenses if you are:
MD – 14/15-
The importation of medical devices requires MD-14 and MD-15 as essential documents which organizations must follow under the Medical Devices Rules (2017) that the CDSCO (Central Drugs Standard Control Organization) administers.
The importation of medical devices which includes IVDs requires foreign manufacturers and Indian importers to obtain these documents for entry into India.
A foreign manufacturer cannot apply directly to the CDSCO. They must appoint an Authorized Indian Agent (AIR). This agent must:
The standard import license for drugs is found in Form 10 which the Central Drugs Standard Control Organization issues.
Form 10 serves as the ultimate “Golden Ticket” which enables an Indian business to conduct legal drug imports through Indian Customs. You cannot bring any drug into India for commercial sale or manufacturing without this license.
The Application: Filed on Form 8.
Certificate of Free Sale or Certificate for Export, is an official document that confirms a product is legally manufactured and freely sold in the domestic market of the exporting country.
In the medical field, it is essentially a “passport” for your product to enter international markets. Foreign governments require it to ensure they are not importing “export-only” goods that the home country does not trust for its own citizens.
The Indian pharmaceutical and medical device sectors use a Non-Conviction Certificate (NCC) as an official document which confirms that a business operates with a complete legal record. The document establishes that the organization together with its leadership team has maintained a record of no convictions during the specified duration for violations of the Drugs and Cosmetics Act of 1940 and the Medical Devices Rules of 2017.
The certificate is a formal declaration by the government that:
Market Standing Certificate (MSC) is a formal regulatory document that proves a company has been actively and consistently manufacturing or importing a product in the Indian market for a specific period (usually the last 3 years).
The MSC acts as an official “track record” issued by the government. It confirms three main things:
In the medical field, this certificate is a mandatory “entry pass” for:
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