Medical Device Registration in India
Medical device regulation in India is managed by the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health. These devices are regulated by the Drugs and Cosmetics Act of 1940. The Indian government regularly updates these regulations to address advancements in medical technology, including devices, software, and artificial intelligence.
In 2017, India introduced the Medical Device Rules (MDR), which established a formal classification system for medical devices. This system was further refined with the Medical Device (Amendment) Rules in 2020.
To register medical devices in India, a manufacturer must take into account the following factors:
Selection of the License Holder
Classification of the medical device in India
Presence of a predicate device in the market and the impact of current global approvals on product registration
Required documents and associated costs for obtaining approval in India
Timelines for approval
1. Selection of the License Holder
In India, it is mandatory for a local Indian company to be the license holder for medical devices. Manufacturers must decide on the license holder while planning their market strategy for India. Even companies that have operated in India for years must comply, as non-regulated medical devices now require registration under the MDR, 2020 Rules.
The license holder can be a local subsidiary, independent agent, or distributor. Using an independent agent can be the most economical and secure method for maintaining compliance, while providing manufacturers with commercial freedom when working with their distribution partners.
The license holder must be a registered business entity in India and possess either a Wholesale Drug License or an MD-42 Medical Device Registration Certificate. Additionally, a SUGAM account is required for submitting files to the CDSCO. The entity must also have an Import Export (IE) Code, a GST Number, and all necessary statutory licenses to import and trade medical products in India.
2. Classification of the medical device in India
You can find detailed classification guidelines in the MDR guidelines, India. CDSCO offers product listings with Generic Name, Intended Use, and Class to assist manufacturers in determining the proper classification for their devices in India. The Indian classification system closely mirrors the EU-MDR classification, providing a valuable reference for manufacturers.
The Indian Classification aligns with the EU-MDR classification, offering a useful reference for manufacturers:
According to the G.S.R. 777(E) notification by the CDSCO on October 14, 2022, Class A non-sterile and non-measuring devices are self-notified, while other medical devices require CDSCO review. This allows the Indian Agent to obtain an automatic registration number on the SUGAM portal for exporting Class A devices. All other classes need a document review by the CDSCO to obtain the Import License.
3. Presence of a predicate device in the market and the impact of current global approvals
Having a substantially equivalent predicate and approval from a GHTF (Global Harmonization Task Force) Country simplifies the approval process in India. Therefore, manufacturers should consider this when planning their registration in India, as it may affect the timelines and costs associated with obtaining the Import License.
Substantially Equivalent Predicate: This refers to medical devices that have approval in India and are similar to the device being applied for in terms of material, intended use, and design.
GHTF Country: Approval from any of the following countries is recognized – Australia, Canada, Europe, Japan, United Kingdom, and the United States of America.
If your medical device does not meet either of these criteria, the CDSCO may require additional review processes based on the device class and availability of clinical data. This could involve a Special Expert Committee (SEC) or a Medical Device Advisory Committee (MDAC) review. Morulaa can assist manufacturers in presenting their clinical data for these reviews, ensuring a smoother and more efficient approval process with the CDSCO.
4. Required documents and associated costs for obtaining approval in India
Upon appointing the Indian Agent and determining the class of the medical devices, an application with supporting documents and fees must be submitted on the SUGAM portal to register the medical device with the CDSCO.
This process involves submitting an MD-14 application form that includes essential information about your medical device, such as its Generic Name, Brand Name, Grouping, Intended Use, Material of Construction, Model Numbers, and Accessories.
The following documents must be submitted to the CDSCO for review:
Certification documents (ISO 13485, Free Sale Certificate, Declaration of Conformity, etc.)
Manufacturing Site documents (Plant Master File)
Technical File documents (Device Master File)
These documents must be submitted in English. During the final step, the CDSCO fees must be paid to proceed with the submission.
Detailed list of documents required for the MD-14 application can be found on this article link. The requirements are similar to those of GHTF countries and can be easily met if your medical device has approval in one of those markets.
After the dossier is submitted, the CDSCO reviews the files and raises queries as needed. Once the CDSCO is satisfied with the responses, it issues an MD-15 Import License, which can be used to export medical devices to India.
The table below gives the application fees based on the classification of the medical device by the CDSCO in India:
5 Timelines for approval
The registration process for medical devices in India typically takes 6-9 months after submitting a complete and accurate regulatory dossier along with the required fees to obtain the Import License. The review period pauses when a query is raised and resumes once it is addressed. New products without strong predicates in India may take longer and might require an MDAC or SEC review for approval based on CDSCO recommendations.
After obtaining the license, it generally does not expire; however, license retention fees are due every five years. It is crucial to keep the CDSCO updated with any post-approval changes made to the medical device as they occur.
How Can Morulaa Help?
When you choose Morulaa as your Regulatory Importer, you can rest assured that you will have more control over compliance in your distribution chain with little effort on your part. We are making regulatory compliance simple for 500+ manufacturers of medical devices and IVDs.
Morulaa was created to offer medical device manufacturers a solution to meet compliance regulations seamlessly and efficiently, especially with the introduction of the new European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Regulation (IVDR). Similar or identical requirements are also mandated in the UK, Switzerland, US, India, and Australia.