India Medical Device Registration

Medical Device Registration in India: CDSCO Regulations, Licensing, and Market Access Requirements (2023 Update)

Updated on 01/04/24

Regulatory Authority: Central Drugs Standard Control Organization

The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) of India, responsible for regulating drugs and cosmetics under the Drugs & Cosmetics Act, 1940 and rules 1945.

It aims to ensure patient safety, rights, and well-being by ensuring the safety, efficacy, and quality of medical products manufactured, imported, and distributed in the country. CDSCO is responsible for drug approval, clinical trials, setting standards, controlling imported drug quality, and coordinating activities of State Drug Control Organizations.

It also grants licenses for specialized categories of critical drugs such as blood and blood products, I.V. fluids, vaccines, and sera, in collaboration with state regulators. The CDSCO strives for transparency, accountability, and uniformity in its services to ensure the safety, efficacy, and quality of medical products in India.

Link for Regulatory Authority:https://cdsco.gov.in/opencms/opencms/en/Home/

Local Regulation:Medical Device Act, 2017

Classification:Class A, B, C and D

Listing or Registration Requirements:

• A voluntary registration pathway is available to medical devices from April 1, 2020, to October 1, 2021. Medical devices submitted under the new voluntary rules are referred to as “Non-Regulatory Medical Devices.” The registration process will generate a file number the same day which the importer must mention on the label of the medical device prior to placing the devices on the market.
• After this voluntary period, all classes of products will need to either have an Import License or register through CDSCO’s online portal.
• Class A and B non-Notified medical devices will have 12 months (i.e., by October 1, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1, 2023) to meet the same requirement.
• Registration for non-notified medical devices has become mandatory since October 2021.
  • Starting October 2022, class A & B non-notified devices will become notified devices and hence will require full product registration.

Starting October 2023, class C & D non-notified devices will become notified devices and hence will require full product registration

Documents Required:

• Form 40
• TR6 Challan
• Power of Attorney
• Schedule D(I)
• ISO 13485 Certificate
• Full Quality Assurance Certificate
• CE Design Certificate
• Declaration of Certificate
• Free Sale Certificate
• Certificate of Marketability from GHTF countries
• Regulatory Approvals
• PMS Report
• Plant Master File
• Device Master File

Registration Timeline:6 to 9 Months

Registration Fee:Fee Details CDSCO

Application fees (online):

• Class A: INR 500 (one site); INR 50 (each distinct device)
• Class B: INR 1,000 (one site); INR 500 (each device)
• Class C and D: INR 5,000 (one site); INR 1,000 (each device)

Application fees (hard copy):

• Class A: INR 2,000 (one site); INR 500 (each device)
• Class B: INR 5,000 (one site); INR 2,000 (each device)
• Class C and D: INR 10,000 (one site); INR 5,000 (each device)

License Validity:

• Registration certificate (valid for 3 years):Generally, it’s recommended to apply for renewal 6 months before expiry. This ensures enough time for processing and avoids potential interruptions in business operations.
• Import license (valid for 5 years): You need to submit the renewal application within 3 months of the expiry date.

 Special Labelling Requirements:All the documents must be submitted in English

Additional Comments: Registration for non-notified medical devices has become mandatory since October 2021.

Starting October 2022, class A & B non-notified devices will become notified devices and hence will require full product registration.

Starting October 2023, class C & D non-notified devices will become notified devices and hence will require full product registration

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

Market access requirements:

Commencing October 1, 2023, the acquisition of an MD-14/15 Import License becomes obligatory for all Class A (Measuring and Sterile), B, C, and D medical devices intended for importation. The MD-14 application procedure mandates the submission of a comprehensive Device Master File (DMF) specific to each product, along with a Plant Master File (PMF) providing details about the manufacturing facility. Upon a meticulous approval process, an MD-15 Import License will be issued to a local license holder for the manufacturing site, covering a comprehensive list of all approved medical devices.

As outlined in the Circular (PDF) released on October 12, 2023, it has been specified that non-Notified Class C and D medical devices enlisted in the mandatory registration program, and concurrently undergoing a pending MD-14 application, are granted permission to continue their importation activities for a period of six (6) months.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]