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Medical Device Registration

In 2017, government authorities have decided to refurbish the medical device registration process by issuing Medical Device Rules. India's medical device market has a huge scope in the upcoming time because of increasing health awareness; increase in government health initiatives and also because of growing middle class living standard.

  • Eligibility Consultation
  • Document Preparation
  • Application Drafting
  • Application filling
  • Government Fees
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Overview of Medical Device Registration

The Indian medical regulatory framework has gotten increasingly muddled as of late. In the past, the need to obtain medical device registration never emerged, but the similar things did not fit in today’s scenario. At present, in India, there are around 30 device families that defines which specific medical device need to be registered.

India's medical device market has a huge scope in the upcoming time because of increasing health awareness; increase in government health initiatives and also because of growing middle class living standard. In 2017, government authorities have decided to refurbish the medical device registration process by issuing Medical Device Rules. The rules came into effect in January 2018 after which devices are being monitored by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Drugs.

The Central Drug Standards Control Organization (CDSCO) is India’s primary legislative body for regulating and managing pharmaceuticals and medical devices.

The Central Drug Standard Control Organization (CDSCO) appoints the Drug Controller General of India (DCGI) who is responsible for approving manufacturing of certain drugs such as vaccine, large volume parenterals, blood product, r-DNA, specific medical devices and new drugs.

India’s Drugs and Cosmetic Act and Rules (DCA) regulates manufacturing, import, sale and distribution of medical devices in India.

Medical Device Registration Changes in India

No medical device guidelines existed in India preceding 2005. Nonetheless, today there is medical device registration systems for specific types of medical devices managed under the Medical Device Rules. Though regulated products have a specific list but every now and then CDSCO adds a few products to the list.

At present just 40-50 medical devices need registration. For all other medical devices that don't need to go through registration process, the manufacturer ought to get a No Objection Certificate (NOC) from the DCGI. The NOC is a letter from the DCGI expressing that the item doesn't require registration and can be used for import purpose freely in India.

Different Regulatory Classifications for Medical Devices

Different Regulatory Classifications for Medical Devices

Medical Device Registration

Quality Management System (QMS) Assessment

According to the new guidelines, “third party conformity assessment and certification” procedure has been introduced with the help of Notified Bodies. The notified body enjoys the authority to perform QMS evaluation at the manufacturing location for Class A and Class B devices. On request, the notified body can also support CDSCO by going for Class C and Class D medical devices’ manufacturing location QMS assessment. CDSCO will then display the accredited list of notified bodies on its website. In case of foreign manufacturers, CDSCO may also go through an inspection of the abroad manufacturing website, conducted by either an in-house CDSCO or by any notified body.

Documents Required

List of documents that an applicant may need at the time of Medical Device Registration process:

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

Medical Device Registration Process

The State Licensing Authority (SLA) will direct the Manufacturing License for Class A and Class B devices, though Class C and Class D license application will be introduced to the Central Licensing Authority (FSSAI). For Class B, Class C, and Class D devices a Quality Assessment Report (QAR) is submitted and that’s too with a manufacturing license application. In contrast, for Class A medical device QAR is submitted within 120days from the date of issuance of Manufacturing License.

If you are planning to apply for an import license then it is essential to obtain the license for manufacturing and distribution as well. Foreign Manufacturers ought to delegate an approved Indian agent to hold the license and conduct Post Marketing Surveillance (PMS) exercises, as well as distribution of medical devices. Import License applications for all classes of medical devices are to be introduced to the Central Licensing Authority.

Rather than the Manufacturing License, an Import License doesn't require a QAR, however the Central Licensing Authority may review the foreign premises, whenever required. To make the new rule more rigid, it becomes compulsory to submit the complete Technical File and Import License Application to the Central Licensing Authority, and each Indian agent will be answerable for the PMS exercises within the nation. Different Indian agents can have multiple Import Licenses under the 2017 rules.

All licenses allowed are perpetual until authorities decide to cancel them. So as to hold the license, one is required to pay license maintenance expenses every five years.

Steps for the Medical Device Registration Process in India

Medical Device Registration Process

Non-Regulated Medical Devices with a NOC are exempt from registration

Non-Regulated Medical Devices with a NOC

Clinical investigation

The Medical Device Rules, 2017 changed the clinical preliminary situation for an investigational medical device from a four-stage preliminary — like those for drugs, per Schedule Y — to a two-stage preliminary. The two stages will be partitioned into pilot clinical examination (Exploratory Study) and essential clinical examination (Confirmatory Study). Furthermore, PMS additionally is obligatory after obtaining marketing approval for the device. Though, in case of an Import License of a medical device with no predicate device in India, clinical examination would not be required if a Free Sale Certificate (FSC) has been given by a skilled authority from Australia, Canada, Japan, the United States, or member state of European Union.

Also, a new rule is introduced as per which "Substantial Equivalence" to a predicate device for medical devices (aside from investigational medical devices) has been launched. If there should be an occurrence of in-vitro diagnostics, "Clinical Performance Evaluation" will be a crucial part of the regulatory needs.

Labelling

It is obligatory to follow labelling necessities as per the specifications mentioned in the new rules. Furthermore, the Indian government additionally has made it compulsory to follow the Legal Metrology (Packaged Commodities) Rules, 2011.

Timeline

It takes around 6-9 months to finish the medical device registration process in India, if a Technical Presentation or Subject Expert Committee (SEC) audit isn't required. A Technical Presentation or SEC survey will expand the time allotment by roughly 3-6 months.

Public Procurement Order

To improve environment for household producers, Government of India (GoI) brought draft rules for PPO. These guidelines cover tenders esteemed at 50 lakhs or less for the public procurement of medical device. Local content cost is determined on the basis of manpower and country of origin of material. The government has come up with a formula to figure out neighbourhood content:

D= (A/C)*100

(C=A+B)

D= Percentage of Local Content

C= Total Cost

B= Cost of Imported component

A= Cost of Domestic component

Frequently Asked Questions

The Central Drug Standards Control Organization (CDSCO) is India’s primary legislative body for regulating and managing pharmaceuticals and medical devices.

  • Class A

    Low Risk (example: thermometers, tongue depressors)

  • Class B

    Low-moderate Risk (example: hypodermic needles, suction equipment)

  • Class C

    Moderate-high risk (example: lung ventilator, bone fixation)

  • Class D

    High Risk (example: heart valves, implantable devices)

D= (A/C)*100

(C=A+B)

D= Percentage of Local Content

C= Total Cost

B= Cost of Imported component

A= Cost of Domestic component

This depends on case-by-case basis. In a few cases, foreign clinical data is accepted.

No, often foreign testing reports are considered.

Yes, obtaining the approval from the country of origin is necessary for medical device registration in India.

  • Companies must register regulated medical devices with the DCGI before they can be introduced into the Indian market.
  • For new medical devices, prior approval from the DCGI must be obtained before the device can apply for registration.
  • Upon receipt of the application with fees, evaluation begins.
  • The DCGI may require clinical testing in India or abroad.
  • The DCGI may visit the manufacturing premises during the process.

The FDA for the most part orders medical devices dependent on the dangers related with the gadget and by assessing the measure of guideline that gives a reasonable confirmation of the device's security and adequacy.

At present just 40-50 medical devices need registration. For all other medical devices that don't need to go through registration process, the manufacturer ought to get a No Objection Certificate (NOC) from the DCGI. The NOC is a letter from the DCGI expressing that the item doesn't require registration and can be used for import purpose freely in India.

It takes around 6-9 months to finish the medical device registration process in India, if a Technical Presentation or Subject Expert Committee (SEC) audit isn't required. A Technical Presentation or SEC survey will expand the time allotment by roughly 3-6 months.

Class II devices are basic devices, however they are more confounded than Class I devices. They are likewise viewed as at marginally higher hazard than Class I devices and subsequently require progressively severe administrative controls to give confirmation of their adequacy and safety.

Class II devices are intermediate-risk devices. Such as, computed tomography (CT) scanners or infusion pumps for intravenous medications. Class III devices are high-risk devices that are crucial to health or sustaining life. Examples include pacemakers and deep-brain stimulators.

Class II medical devices are those devices that have a moderate to high hazard to the patient or to the user. 43% of medical devices fall under this class. Most medical device are viewed as Class II devices. Instances of Class II devices incorporate controlled wheelchairs and some pregnancy test units.

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