In February, India’s Ministry of Health and Family Welfare released its Medical Device Rules, 2017, a 142-page document that lays out all of the details of the regulations that are now being placed on medical devices that will be sold in the country.
Until now, outside of a list of just 10 devices, medical devices were not regulated at all in India. If medical device companies wanted to penetrate India’s market, all that was needed as an import license. However, this policy is no longer sufficient for India’s medical device industry, one that has been growing at an annual rate of 17 percent since 2012 and is currently valued at $5.5 billion. With growth must come stricter regulations.
While India is not the only entity enacting monumental policy changes for its medical device industry (the European Union recently released its Medical Device Regulations, which in 2020 will replace policies that have not changed since the 1990s), it is the only entity whose market-rattling changes are going into effect in less than seven months.
Here are the top 10 things you need to know about India’s new medical device regulations:
- These regulations go into effect next year.
The Medical Device Rules, 2017 will come into force with effect on January 1st, 2018 and will be applicable to medical devices and in-vitro diagnostic medical devices.
- The old 10-device list has been replaced by four classes that will categorize all medical devices that will be sold in India.
All medical devices will be placed into one of four classes based on the intended use of the device and the potential risk that comes with its use. Here are the classifications:
- Class A (low risk)
- Class B (low moderate risk)
- Class C (moderate high risk)
- Class D (high risk)
Each class has different regulatory processes. The higher the risk, the more strenuous the approval process.
- Online applications for licenses to sell and distribute can be completed online.
Conveniently, the application for a license to manufacture for sale or for distribution for medical devices of any class can be found, completed, and submitted on the Ministry of Health and Family Welfare’s online portal.
- Notified Bodies will audit manufacturing sites and products to ensure conformity to standards.
Notified Bodies are nationally accredited third-party entities that are licensed by the government to audit all medical devices and their manufacturing sites to verify that they conform to the Quality Management System and all other applicable standards prescribed by the Bureau of Indian Standards.
- Foreign manufacturing sites may be subject to inspection by India’s Central Licensing Authority.
Manufacturing sites that are not located in India may require inspection by the Central Licensing Authority or a federally appointed and registered entity. In the event that inspection is requested, the applicant will be subject to a $6,000 Ã‚Â inspection fee.
- In 2020, approved medical devices must bear unique identifiers.
Starting on January 1st, 2022, medical devices that are approved for import, sale, or distribution in India must bear two different types of unique identifiers: the device identifier and the production identifier. The device identifier is a global trade item number and the production identifier is the device’s serial number, lot/batch number, software version, and/or manufacturing and/or expiration date.
- Medical devices novel to the Indian market are subject to special regulations.
An application for grant of permission and clinical investigation is required for any medical device (except for those in Class A, in some cases) which does not have its predicate device on India’s medical device market before it is sold or distributed in India. If the device has been approved by the regulatory authority in the U.S., the U.K., Australia, Canada, or Japan, the device has been marketed in that country for at least 2 years, and the data of safety, performance, and pharmacovigilance of the device complies with the standards of the Central Licensing Authority, additional clinical investigation may not be required for that device.
- Not all medical devices will require clinical investigation
If a Certificate of Free Sale has already been issued for a medical device by the regulatory authority of the U.S., the European Union countries, Australia, Canada, or Japan, clinical investigation is not required for that medical device.
The rules are different for medical devices that have not been approved in the aforementioned countries. Published safety and performance data or clinical investigation in the country of origin and a Certificate of Free Sale from the country of origin are required for all Class A and Class B devices. Clinical investigation in India is required for all Class C and Class D devices.
- Application fees are higher than before.
While the costs of securing a license to manufacture for sale or for distribution for a medical device are nominal, they are more expensive than an import license fee. The Medical Device Rules, 2017 includes an itemized list of costs that correlate to each stage of the application and regisration process.
- Registration Certificates last for five years.
India’s certificate renewal process is much less rigorous than that of other countries. To maintain the indefinite validity of the certificate, its holder must pay a registration retention fee of 20,000 rupees (approximately $310) every five years from the date of issue.
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