India tightens Quality Standards for Medical Devices

India’s Central Drugs Standard Control Organization (CDSCO) publication Medical Device Rules 2017 made sweeping changes in regulation of medical devices to improve quality healthcare and raise manufacturing and safety standards. The framework has been effective since 2018 and has improved standards in registration, regulation and safety. These changes complement the Drugs & Cosmetics Act, which only regulates 23 medical devices as drugs. CDSCO rules are more comprehensive in bringing medical devices into specific regulation and safety standards.

Many medical devices and equipment have not been regulated by Indian authorities. Standards in India had been relying on foreign quality standards and according to the Times of India, over 80% of medical devices are imported. The 2017 rules will now require foreign manufacturers to register devices with an Authorized Agent, who in turn would be mandated to have license to sell and distribute medical devices.  Regulators will have the option of requiring on-site audits of overseas manufacturing facilities. Most likely waivers will be made for American, European Union, Canadian, Japanese and Australian imports.

There are new classifications for devices, rules for foreign manufacturers and audits, a new fee structure, and licensing standards. Starting in 2022 Unique Device Identification (UDI)s will be required of all medical devices and IVDs. Test licenses will be valid for three years instead of one year. CDSCO will now assign classification to devices, rather than manufacturers, further tightening standards.  Most notably, these changes will mirror ISO 13485:2003, elevating India’s standards in the global market.

India is currently the fourth largest medical device market in India worth $7 billion. Accordingly, the market potential is $50 billion by 2025. These improvements in standards position India’s market potential while providing significant healthcare standards across the board. As debate ensues regarding tariffs in the Asian, European and American markets, could India be healthcare manufacturers’ best next thing?

Differences between 510(k) and De Novo Submission

Differences between 510(k) and De Novo Submission

Traditionally, Class II medical devices would have 2 routes for FDA submission:

  1. 510(k), which would require a substantial equivalence (SE) analysis based on previously FDA cleared device. Substantial equivalence requires the device is as safe and effective as the predicate device. Additionally, it requires the same intended use and technological characteristics as the predicate device. In today’s world of novel and innovative medical technology, meeting these requirements is increasingly difficult.
  2. In the event substantial equivalence cannot be proven, the device is to automatically be classified as class III and require a PMA (Pre-Market Approval) submission. As such, the PMA submission process is quite rigorous, especially for a class II, medium risk device.

In light of this situation, over the last few years, the FDA has created a De Novo submission program, which allows for novel technologies (i.e.: lacking SE) to be classified as a class II device, with a submission not quite as rigorous as the PMA submission.

The De Novo submission process is similar in complexity to the 510(k) submission, but there are a number of differences:

  1. Clinical Investigations – while clinical trials are sometimes not required for 510 (k) submissions (when based on previous clinical results for SE devices), clinical trials are required for virtually all De Novo submissions.
  2. Risk Factor – For a De Novo submission, the manufacturer must prove that the risk factor presented with this device is a medium risk (i.e.: not present substantial risk to the patient). As for 510(k) submission, the manufacturer must merely prove that the risk presented by the device is no greater than its SE device.
  3. Submission cost – For the year 2018, the submission fees for the FDA are as follows:
Submission Type Standard Fee Small Business Fee
510(k) $10,566 $2,642
De Novo $93,229 $23,307

If you need assistance making a determination regarding the submission requirements of your device or navigating the difference submission processes, please contact us (link to contact section) today via phone or email for a free consultation.