Registration and Approval Process of Medical Device in India

The amount of study into medical devices has multiplied with the growth of technology and greater scientific inquiry. Increasing the output of these devices is the goal. for brand-new, improvised rules on their to ensure consistency in quality and avoid injecting unsuitable products into a marketplace. Each nation has its own governing body for implementing this purpose. 

Regulatory organizations have developed specific regulations for the manufacture, dissemination, and sale of these gadgets. majority of the Asian nations, such as South Korea, Malaysia, Thailand, Indonesia, Vietnam, the Philippines, and Singapore, medical devices and pharmaceuticals are governed by different regulatory systems. However, In India, medical devices are subject to regulation. 

The same Medications & Cosmetics Act applied to medications in 1940. The Indian government is currently keen on separating pharmaceuticals from medical devices to promote manufacturing, R&D, and imports made into the nation. This article addresses the protocol for using medical devices that is India.

CDSCO's Medical Device Registration Process in India

• Due to massive imports, India is currently one of the major worldwide markets for medical devices. In the past, Indian manufacturers of medical equipment had the freedom to sell their products wherever. Since 2006, all medical devices in India must adhere to the CDSCO's Indian Medical Device Regulations. There is currently a formal process in place in India for the registration of particular types of medical devices that fall under the purview of the Medical Device Rules.

• Medical equipment and IVD (In-Vitro Diagnostics) sold in India are governed by the CDSCO (Central Drug Standard Control Organization). The Drug Controller General of India (DCGI) is in charge of the CDSCO, while the SLA (State Licensing Authority) and CLA (Central Licensing Authority) each have a portion of the approval jurisdiction. In India, the Drugs and Cosmetics Act 1940 and Rules 1945 govern the production, import, sale, and distribution of medical equipment. Therefore, in India, CDSCO Medical Device Registration is required.
• Before, there were no rules governing how these devices were made in India. Manufacturers are able to produce any type of medical equipment without a court order. But in 2006, it was made mandatory for the Indian Medical Device Regulations must be followed when importing medical devices into India. Rules established by the CDSCO. Throughout the past. The Indian medical regulatory framework has only recently has grown extremely complex. There are around 30 "families" of devices that describe the medical devices that require registration.

Definition of Medical Device

All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of

1. Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
2. Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
3. Investigation, replacement or modification or support of the anatomy or of a physiological process;
4. Supporting or sustaining life;
5. Disinfection of medical devices; and
6. Control of conception.

Applicable Laws

• Section 3(b)(iv) of the DCA- Provides for a definition of drugs vis-à-vis medical devices.
• MDR (notified on 31 January 2017) provides for rules & regulations regarding the manufacturing, sale, import, and labeling of medical devices.
• MoHFW vide the second notification (No. S.O 648[E]) dated February 11, 2020, in pursuance of Section 3(b)(iv) notified new medical devices to be considered as drugs as per Section 3(b) of DCA.
• By the Medical Devices (Amendment) Rules, 2020 (Notification No. GSR 102 [E]), newly notified medical devices must be registered.
• A provisional registration number can be generated under the Medical Devices (Amendment) Rules, 2022 (Notification No. GSR 19 [E]).

Eligibility to Apply for the Medical Device Registration

• Domestic Manufacturer
• IAA (Indian Authorised Agent) of the Manufacturer
• Any foreign enterprise holding an Indian Subsidiary
• Importer

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Classification of Medical Device

Information on classes of medical devices

Class A and B

• The manufacturer must submit an application through a designated Ministry online portal with the required paperwork as per the Fourth Schedule and the fees listed in the Second Schedule.
• No class A device audit is required before a license is granted.
• Within 120 days after the license's issuance date, the audit may be completed.
• Before issuing a manufacturing license, a Class B device audit must be completed, and it must be completed within 90 days of the application date.
• The notified body has 30 days to submit its report to SLA.

Class C and D 

• The application must be submitted to CLA via the central government's online portal with the necessary paperwork and costs.
• Within 60 days of the application date, CLA may conduct an inspection with the assistance of an expert and notified body.
• If a facility is already licensed to produce medical devices, there is no need to inspect it to award a loan license.
• When the inspection is over, the inspection team must send the report via the internet link to CLA.

Registration Process of Medical Device

Step 1: Determine if your product requires registration

• Under the Drugs and Cosmetics Act, 1940, and Rules, 1945, the import, manufacturing, sale, and distribution of medical equipment are all regulated in India. Currently, the aforementioned Act regulates 22 Notified Medical Devices.
• Spinal needles, cochlear implants, annuloplasty rings, trachestomy tubes, syringes and needles, surgical sealants, heart valves, cardiac stents, orthopaedic implants, endotracheal tubes, and catheters are just a few examples of medical equipment that must be registered in India. The CDSCO (Documents required to register your medical device in India) should be contacted to register these devices.

Step 2: Appoint an Authorized Indian Agent

An authorized Indian agent can be appointed by a manufacturer to register on their behalf with the CDSCO. This agent will serve as a liaison between you and the CDSCO's Medical Devices Division. A wholesale medicine license in categories 20B and 21B should be held by the designated Indian agent. The maker will hold the registration certificate and be able to choose numerous distributors throughout the nation.

Step 3: Submit the Regulatory Dossier under Form 40

To begin the registration process, a dossier with the necessary list of documents must be completed. An outline of the necessary documents is provided below.

• Form 40
• TR6 Challan
• Power of Attorney
• Schedule D
• ISO 13485 Certificate
• Full Quality Assurance Certificate
• CE Design Certificate
• Declaration of conformity
• Free sale certificate
• Certificate of Marketability from GHTF countries
• Other Regulatory Approvals
• PMS report
• Plant Master File
• Device Master File
• The CDSCO charges US $1500 for registering a single production site and US $1000 for a single product family. The duration of the registration process could range from 6 to 9 months. The procedure time will increase and a special committee will be formed to assess the products' safety and efficacy for the Indian market if they lack a predicate in India.

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Step 4: Obtain a Registration Certificate in Form 41

• After the document submission, the CDSCO will get back to the Indian Agent with the first query letter in about 3 Months Upon receiving the answers for the query the CDSCO will either issue a subsequent query letter or grant a license. The registration certificate is valid for 36 Months.

Step 5: Obtain an import approval using Form 10

• Distributor must submit the Form 10 directly to CDSCO. A Form 8 application must be submitted with a Form 9 that includes the registration certificate number: 4 to 12 weeks are required for this process.

Step 6: Marketing in India

• Once the registration certificate and the import license are issued the product can enter the Indian market Any changes, negative experiences, recalls in other countries, etc. should be immediately reported to the CDSCO by the authorized Indian agent.

Role of the Central Drugs Standard Control Organization (CDSCO) in PMS (Post Marketing Surveillance)

• To maintain compliance with PMS requirements, India's regulatory body Central Drugs Standard Control Organization (CDSCO) is essential. They make sure that producers of medical devices carry out post-market surveillance investigations and submit routine PMS reports outlining the findings of their surveillance operations.
• The Materiovigilance Programme of India (MvPI) was authorized by the Ministry of Health and Family Welfare (MoHFW), Government of India (GoI), and launched in the nation in 2015 with the sole purpose of ensuring the safety and caliber of medical devices used in the nation. 
• Manufacturers, importers, distributors, healthcare professionals, and others can use the adverse event reporting form that MvPI has made available as well as the monitoring centers it has set up. If PMS rules are not followed, there may be consequences such as fines, penalties, or even product recalls.

Future of PMS in India for Medical Devices

• The future of post-marketing surveillance (PMS) for medical devices in India is anticipated to be influenced by a wide range of factors, including developing technology, shifting regulatory frameworks, and growing collaboration between regulatory authorities and medical device manufacturers.
• One significant development that is projected to have an impact on PMS in India is the growing use of digital technology and artificial intelligence (AI) in medical devices. By providing real-time data on device performance and patient outcomes and by making it simpler to identify patterns and trends in adverse events, these technologies expand the potential of PMS.
• Manufacturers and regulatory agencies can immediately detect and address any safety issues or product faults by reviewing this data.

To retain patient trust and confidence in medical devices, producers must abide by the regulatory regulations. PMS plays a crucial role in guaranteeing the safety and efficacy of medical devices in India.

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