Indian Regulators Issue FAQ on Medical Device Rules

EMERGO SUMMARY OF KEY POINTS:

• A new FAQ from the Indian CDSCO addresses several questions regarding compliance with the new Medical Device Rules 2017.
• Issues covered in the FAQ include status of medical device registration applications still under review at CDSCO, notified medical device listing changes and standards compliance.
• India’s Medical Device Rules 2017 went into effect in January 2018.

The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has published a new Frequently Asked Questions (FAQ) document to clarify industry questions regarding the country’s new medical device oversight system.

The CDSCO FAQ addresses compliance with Indian Medical Device Rules 2017, which went into effect in January 2018; since implementation of the new regulations, Indian medical device registrants have raised various questions and concerns regarding issues such as registration renewals, marketing applications currently under review, and changes to the CDSCO list of notified medical devices.

The FAQ includes 55 questions as well as CDSCO responses; below, we summarize some of the key issues covered in the document.

Status of medical device license application renewals still in process

One issue raised in the FAQ pertains to license application renewals that have been pending approval by CDSCO on or after October 27, 2017, as well as license applications submitted before January 1, 2018—when the new Medical Device Rules came into effect—but still awaiting regulatory approval.

• License applicants whose submissions were made to CDSCO on or after the October 2017 date should deposit license retention fees and related documents according to Medical Device Rules 2017 requirements, states CDSCO.
• Companies whose applications were submitted before the January 2018 deadline but have yet to receive final decisions from CDSCO will need to pay any application fee balances and resubmit their applications via the new online registration portal SUGAM.

Adding additional devices to an existing CDSCO license

Some CDSCO registrants have applied to the regulator to include additional devices to existing registrations both before and after the January 2018 deadline, but have not yet received final approval to do so.

These applicants will have to pay additional fees and provide additional documentation according to the Medical Device Rules 2017.

Notified Medical Device listing revisions

One item in the FAQ—when a revised listing of medical devices and IVDs notified for CDSCO registration—is not addressed directly in the document. The FAQ response identifies which devices fall under notification according to the Medical Device Rules 2017, stating only that such lists will be published “in due course of time.”

In-country clinical investigation requirements

The new Medical Device Rules 2017 include in-country clinical investigations and/or evaluations for some devices. Do these requirements apply to devices already commercialized for sale in India?

According to CDSCO, devices will be evaluated based on their intended use on a case-by-case basis in order to determine whether clinical investigations are necessary.

Local versus International device standards

Many manufacturers have questioned whether compliance with international device standards from entities such as the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) would allow registrants to also meet Bureau of Indian Standards (BIS) requirements.

The FAQ states that devices must conform to standards explicitly identified by the BIS; in cases where no appropriate standard has been identified, a manufacturer should ensure compliance to the relevant ISO, IEC or other international standard, or in some instances to the company’s own validated standard.

Additional issues addressed by the CDSCO FAQ

Other key Medical Device Rules 2017 compliance questions addressed in the CDSCO FAQ include:

• India Authorized Agents are responsible for managing post-market surveillance activities.
• Medical Device Rules 2017 risk-based device classification schemes will be harmonized with other international classification systems.
• A firm may pay a single import license fee for a grouped submission so long as all devices in that group share similar technology, intended use and product specifications.
• A manufacturer that changes its India Authorized Agent must obtain a new license from CDSCO.

Manufacturers active in the Indian market should familiarize themselves with the whole FAQ to determine how the Medical Device Rules 2017 will impact their compliance efforts.

Related Indian medical device regulatory resources from Emergo:

• India CDSCO medical device and IVD registration consulting
• India Authorized Agent in-country representation
• India medical device regulatory strategy report
• Regulatory process chart: India’s medical device and IVD approval process
• Video overview: Indian medical device market registration