INDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES

On October 18th, 2019 the Ministry of Health and Family Welfare published a draft of the Medical Device Rules, 2019 as a proposed amendment to the Medical Device Rules, 2017 requiring the registration of all non-Notified medical devices over a 42-month period with the Central Drugs Standard Control Organization (CDSCO). These Medical Device Rules, 2019 will come into full effect after being approved and published in the official gazette. The draft notification allows 30 days from 18 October 2019 for public comment and stakeholder feedback.

The plan calls for an 18-month voluntary registration period after which all class A and B devices would have 16 months to be registered (i.e., by Sep 17, 2022) in the CDSCO’s on-line portal. Class C and D devices would have 24 months to meet the same requirement (i.e., by May 17, 2023).

The registration application involves administrative documents such a Free Sales Certificate from the country of origin, ISO 13485 certificate, as well as basic product information. The registration process carries no government processing fees and do not expire, but may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by the requirement for an Import License (upon Notification). Once registered the local license holder will be required to notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SEA) occurring in India. 

Further, the registration process will generate a registration number which the importer must mention on the label of the medical device prior to placing the devices on the market (i.e., after Customs clearance).

Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate.

Asia Actual is available to answer questions or help register your devices when the new requirements take effect. Contact us to arrange an initial conversation.

INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT

India’s Central Drugs Standards Control Organization (CDSCO) has officially added ‘ultrasound equipment’ to the Notified list of medical devices that require pre-market approval in India. As seen in previous Notifications, the CDSCO is expected to release guidance of risk classification and generic intended use for ultrasound equipment.

Manufacturers and importers of these devices will need to obtain an Import Licenses (Form MD-15) under the Medical Device Rules, 2017 to maintain market access. Products without valid license may not be imported and marketed after November 1, 2020.

Suggested actions:

  • Identify any devices in your portfolio that utilize ultrasound technology
  • Confirm if the intended use matches those listed in the CDSCO guidance document (when available)
  • Prepare for application submission for applicable devices no later than January 1, 2020 to ensure licenses are in place by November 1, 2020

The mandate was published in the Gazette of India on October 16th, 2019 by the Ministry of Health and Family Welfare (Department of Health and Family Welfare). The published announcement constitutes Gazetting, officially implementing the new policy.The resolution to regulate ultrasound equipment was originally raised 21 months earlier at the February 12th, 2018 Drugs Technical Advisory Board (DTAB) meeting.

Asia Actual has a strong regulatory team in India helping companies stay informed and navigate the regulatory changes in India’s dynamic and complex market. Please contact us here with questions or service inquiries.  

4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.

Incorporate Asian Requirements into Product Testing

Conformance testing certificates are a common element of medical device registration applications. In most Asian regulatory systems, test reports used for US and European device registration are sufficient, with notable exceptions. South Korea and other markets require CB Scheme certification for electrical safety testing certificates. Further, testing records should be generated based on a country’s electrical supply (e.g., 220V/60Hz and/or 380V/60Hz). In Indonesia, Certificates of Analysis require numeric test values as well as a pass/fail designation. In China, in addition to having a complete set of test certificates to international standards, registration of Class II and III devices will require test certificates generated from one of ten local CFDA-certified test laboratories.

Design Your Clinical Trial to include Asian Requirements

If you must conduct a clinical trial in support of FDA Approval or CE Marking, confirm the data generated will also be acceptable for device registration in Asia. The Pharmaceutical and Medical Devices Agency in Japan offers a Clinical Trial Consultation just for this purpose. You may also consider the Harmonization by Doing program in Japan, which is designed to reduce the cost and time to register novel devices significantly by shifting 25% of your patient sample from a US clinical trial to Japan. The Central Drugs Standard Control Organization (CDSCO) in India will generally accept clinical data from outside India (except for drug-eluting stents, etc.), but may want to see ethnicity data. Again, Chinese registration of Class II and III devices will require a limited local clinical trial data.

Select a Fully Recognized Notified Body

Pick an ISO 13485 Registrar and CE Mark Notified Body that is recognized by competent authorities in Asia to avoid redundant QMS inspections and product conformity assessment fees.

Examples:
    • The Australian government has a mutual recognition treaty with the European Union whereby medical devices with CE Mark avoid local conformity assessment, greatly accelerating market listing in Australia. However, the Australian government has begun to deny recognition of certain Notified Bodies.
    • In Japan, if your device qualifies for Pre-Market Certification (most Class II and some Class III devices), conformity assessment will be performed by a private Registered Certification Body. Seven of the fourteen RCBs also provide CE Mark in Europe.
    • In Korea, a similar situation applies to most Class II devices.
    • In Malaysia’s new and evolving regulatory system, all devices must undergo local conformity assessment, though the assessment for devices with reference country approval is greatly expedited. In these cases, manufacturers may request synergies if their Notified Body is also their RCB in Japan or Third Party Reviewer in Malaysia and South Korea.

Budget to Control Your Registration Certificate in Asia

In the US, Europe and Canada, the manufacturer on the labeling is considered the owner of the product registration certificate. In all other regulatory systems, the license/certificate/listing is owned or fully controlled by a local agent. In these markets, foreign manufacturers can only change or add distributors with the cooperation of the incumbent license holder. If the license is held by a commercial distribution partner, it is difficult to add, change or influence distributors in that market. Also, start-up companies with acquisition strategies have added incentive to control registration certificates to enhance acquisition value and enable the acquiring company to integrate new device/s into its direct sales channel. This situation can only be assured through an independent license holder.

Contact Asia Actual for specific conditions that apply to your devices in Asia.

INDIA COMPLIANCE MAINTENANCE: NOTIFIED BODY CHANGE

Given recent conditions of Brexit, many companies are impacted with changes regarding their notified body. This change ultimately changes the CE Mark on labeling, thus requiring amendments to any existing Import Licenses in India.

In order to remain compliant, our experts suggest to follow the post approval changes as per the Medical Device Rules 2017 (page 59)

Per the post approval change Rules, there is no specific  guidance  on “a change in number on the CE Mark/ Change in Notified Body”. For instance, even though the change of Notified Body from BSI UK to BSI Netherlands may not  affect quality in respect of its specifications, indication for use; performance and stability of the medical device, it may still be considered a major change as there will be changes  to labels  (refer point below). It may also be that the approval itself is based on the CE mark (EU nation FSC submitted at the time of registration in India) and in such a case the regulator may deem this to be a major change.

Further, if we see options under post-approval changes in the online system, then for Import Licenses in Form MD-14, following options appear:

Therefore, the suggestion is to select Category 7: change label excluding change in font size, font type, color, label design

Action For Major Changes

The authorized agent, shall obtain prior approval from the Central Licensing Authority before any major change, as specified in the Sixth Schedule, is carried out and the Central Licensing Authority shall indicate its approval or rejection within sixty days.

If no communication of approval or rejection as referred to in clause above is received within the stipulated time from the Central Licensing Authority, such change shall be deemed to have been approved.

Documentation Required Would  Include:
  1. Notarized letter from Manufacturer on their letterhead, addressed to the CDSCO explaining the details of the  change and circumstances leading to the change. Letter must confirm that the change is restricted to a change of address and further confirm that there are no changes whatsoever to previously submitted site master file and device master file; no changes in manufacturing site, device registered in India, device intended use, materials of construction, manufacturing and testing processes, performance, safety, risk class, stability, biocompatibility, shelf life etc.
  2. Notarized copies of new certifications issued by The Notified Body, notarized CE Certificate, ISO 13485 Certificate, CE Full Quality Assurance Certificate, CE Design Examination Certificate, as applicable.
  3. Confirmation that this change does not require an approval in the country of origin. If it does need approval in the country of origin, then notarized evidence of such approval is to be submitted.
Contact Asia Actual

Asia Actual is available to answer questions and help navigate you through any compliance maintenance issues you may face. Contact us to arrange an initial conversation.

INDIA PLANS TO REGULATE ALL MEDICAL DEVICES

At the April 2nd DTAB meeting, the DCGI presented a proposal to regulate all medical devices over a 42-month period. Non-Notified devices would require registration in a phased in approach. This would allow an 18-month voluntary registration period after which class A and B devices would have 12 months to obtain an Import License (MD Form 15) prior to importation.  Class C and D devices would have 24 months to meet the same requirement.

Implementation could happen quickly. The proposed plan closely matches details that were discussed at a meeting hosted by the Central Drugs Standard Control Organization (CDSCO) held on February 8, 2019 with industry stakeholders.  Once the plan is endorsed by the DTAB, the MOHFW is expected to establish the implementation date quickly. Perhaps as early as the third quarter of 2019.

Voluntary registration would involve typical administrative documents such as reference country approval certificate, ISO 13485 certificate, etc.  The voluntary Registration Certificate carries no processing fee and no expiry date.  However, once registered the local license holder would be required notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SEA) occurring in India.

The CDSCO review process to generate a MD Form 15 typically takes 6 to 9 months with 6 to 8 weeks of application preparation. To be safe, manufacturers should begin the MD Form 15 application process 12 months before any deadline.

Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate and Import License.

Asia Actual is available to answer questions or help register your devices when the new requirements take effect. Contact us to arrange an initial conversation.

INDIA TO REGULATE SURGICAL DRAPES AND GOWNS

At the April 2nd Drugs Technical Advisory Board (DTAB) meeting, the board deliberated upon and agreed to add (1) surgical gowns, (2) surgical drapes, and (3) incision drapes to the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India.

Next the Ministry of Health and Family Welfare must issue a Gazette Notification for the requirement to become official. Based on past experience,  it is expected to take approximately 5 months from a positive DTAB board resolution to Notification with a likely 12-month transition period for compliance. Manufacturers of these devices should take urgent action to prepare registration applications to maintain access to the Indian market.

Asia Actual has a strong regulatory team in Delhi to help companies stay informed and ahead of regulatory changes. Visit our market info page for the most up-to-date list of notified medical devices requiring registration.

We also provide efficient, transparent management of medical device regulatory, vigilance and importing activities in this dynamic market.

Please contact us with questions or service inquiries.Attachments area

INDIA MOVES QUICKLY TO REGULATE ORGAN PRESERVATION SOLUTION

On April 2nd, the Ministry of Health and Family Welfare published a special notification requiring organ preservation solution to be registered as a drug with immediate effect and no grace period.

In order to import and sell organ preservation solution in India, products must now have in place a Registration Certificate (Form 41) and then an Import License (Form 10) as per the Drugs and Cosmetics Rules, 1945. The Review time for each application is approximately 6 to 9 months and 4 to 6 weeks respectively.

Previously organ preservation solution was considered a non-Notified medical device in India. Multiple No Objection Certifcates (NOC) were issued between 2010 and 2018 clarifying the non-Notified status of specific organ preservation solution devices.

Then at the February 12, 2018 Drugs Technical Advisory Board (DTAB) meeting, organ preservative solution was slated for Notification as one of the first medical devices to be newly regulated under the Medical Device Rules, 2017. At that time, it was expected to require an Import License (Form MD 15) to import and sell organ preservative solution in India by early 2019.

This Notification announcement (available here) represents a departure from the anticipated process to add devices to those that require registration in India. Manufacturers of currently non-Notified devices should be vigilant about pending registration requirements.

Contact Asia Actual with any questions or requests for support to register your devices in India.

INDIA REQUIRES MORE NEW DEVICES TO BE REGISTERED UNDER NEW MEDICAL DEVICE RULES, 2017

India’s Central Drugs Standards Control Organization (CDSCO) has officially added eight more medical devices to the list requiring registration. The new additions are:

(1) X-ray machines,
(2) CT scan equipment,
(3) MRI equipment,
(4) PET equipment,
(5) defibrillators,
(6) dialysis machines,
(7) bone marrow cell separators,
(8) all implantable medical devices.

Manufacturers and Importers of products under these categories need to immediately apply for import licenses in Form MD-14 of the Medical Device Rules, 2017. Products without valid registrations may not be imported and marketed after April 1, 2020.

The mandate was published in the Gazette of India on February 8th, 2019 by the Ministry of Health and Family Welfare (Department of Health and Family Welfare). The published announcement constitutes Gazetting, officially implementing the new policy.

The resolution to regulate this list of devices was originally raised 10 months earlier at the May 16th, 2018 Drugs Technical Advisory Board (DTAB) meeting.

Asia Actual has a strong regulatory team in India helping companies stay informed and navigate the regulatory changes in India’s dynamic and complex market. Please contact us here with questions or service inquiries.

INDIA OFFICIALLY REQUIRES FIRST NEW DEVICES TO BE REGISTERED UNDER NEW MEDICAL DEVICE RULES, 2017

India’s Central Drugs Standards Control Organization (CDSCO) has officially added four medical devices to the list requiring registration. The four new additions are:

(1) glucometers,
(2) blood pressure monitoring devices,
(3) nebulizers, and
(4) digital thermometers.

Manufacturers and Importers of products under these categories need to immediately apply for import licenses in Form MD-14 of the Medical Device Rules, 2017. Products without valid registrations may not be imported and marketed after January 1, 2020.

The mandate was published in the Gazette of India on December 3rd, 2018 by the Ministry of Health and Family Welfare (Department of Health and Family Welfare). The published announcement constitutes Gazetting, officially implementing the new policy. The resolution to regulate this list of devices was originally raised 5 months earlier at the July 25th, 2018 Drugs Technical Advisory Board (DTAB) meeting.

It is worth noting that prior DTAB meetings yielded announcements that various other devices would soon require registration. However, since, they have not been Gazetted to date.

Asia Actual has a strong regulatory team in India helping companies stay informed and navigate the regulatory changes in India’s dynamic and complex market. Please contact us here with questions or service inquiries.