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.

India to Regulate Glucometers, Blood Pressure Monitors, Nebulizers and Digital Thermometers

At the July 25th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed to add (1) glucometers, (2) blood pressure monitoring devices, (3) nebulizers, and (4) digital thermometers 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.

This is the third Notification announcement since the Medical Device Rules, 2017 were enacted on January 1st of this year. The decisions are coming with increased frequency, so manufacturers of non-Notified devices are advised to stay alert for announcements and make early registration preparations.

Asia Actual has a strong regulatory team in Delhi to help companies stay informed and ahead of regulatory changes.

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.

India to Regulate More Medical Devices

At the May 16th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed that expands the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India. The following device categories are affected:

  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

Next the Ministry of Health and Family Welfare must issue a Gazette Notification for the requirement to become official. It is expected to take 5 months from DTAB board resolution to Notification with a 6-month grace period for compliance. Important guidance on specific devices to be included as well as classification confirmation are not yet available. Manufacturers of these devices should take urgent action to prepare registration applications.

This is the second Notification announcement since the Medical Device Rules, 2017 were enacted on January 1st of this year. From the early pattern it appears that new devices will be added at each quarterly DTAB meeting. The next is scheduled for mid-August. Manufacturers of non-Notified devices should stay alert for future announcements and make early plans to maintain continued access to the Indian market.

Asia Actual has a strong regulatory team in Delhi to help companies stay informed and ahead of regulatory changes.

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.

India to Require Ultrasound and Imaging Equipment to be Registered with the CDSCO

At the February 12th Drugs Technical Advisory Board (DTAB) meeting, a resolution was approved to add “ultrasound equipments and similar imaging equipments” to the list of notified notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India. Organ preservation solution was also added to the list of notified devices.

Next the Ministry of Health and Family Welfare must issue a Gazette Notification for the requirement to become official.   The last devices to go through this process, ablation devices, took 5 months from board resolution to Notification with a 6-month grace period for compliance.

Important guidance on specific devices to be included as well as classification confirmation are not yet available. Any manufacturers of medical devices including ultrasound technology, or medical imaging equipment in general should stay alert for updates and have plans for eventual registration.

This is the first Notification announcement since the Medical Device Rules, 2017 were enacted on January 1st of this year. Industry is watching closely for patterns useful to predict future device additions.  Many more are expected in the coming  months.

New Regulations in India Raise the Bar for Many IVD Devices

The new Medical Device Rules, 2017 that took effect January 1, 2018 significantly expands the number of IVD devices requiring full technical documentation in support of their Import License applications. Formerly only 4 critical IVD devices required registration with complete Device Master  File with the Central Drugs Standard Control Organization (CDSCO) prior to being placed on the market in India.  Under the new Rules, all reagents and test kits must obtain MD Form 15 prior to importation, however any IVD device covered by an Import License (Form 10) granted under the old Rules will remain vaild until the expiry date (maxiumum validity of three years).

Required elements of the new registration application include: 1) proof of reference country approval, 2) ISO 13485 certification of the manufacturing facility, and 3) full technical details as per the prescribed requirements of the device master file.

More time, effort and expense will be required for most IVD reagent and test kits to maintain or gain market access.

Further, performance evaluation reports from the National Institute of Biologicals (NIB) are required for HIV, HBsAg, HCV and blood grouping sera tests as before. Seven other IVD tests (i.e., Malaria, Dengue, Chikungunya, Syphilis, Typhoid, Tuberculosis, Cancer markers) that formerly required performance evaluation reports from a local National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratory, now required the same for the NIB.

The CDSCO processing fees vary by risk classification as per the table below.  Processing times are expected to take 6 to 9 months.  Successful applicants will be issued an Import License (aka MD Form 15) which is valid for perpetuity, with retention fees due every five years.

Classification Type                Plant Master File       Device Master File

A IVD Device                          US$1,000                    US$10
B IVD Device                          US$1,000                    US$10
C IVD Device                          US$3,000                    US$500
D IVD Device                          US$3,000                    US$500

Contact Asia Actual with questions or to manage and submit Import License applications and local performance testing to ensure the efficient, timely and secure issuance of certificates.