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.

India’s New Medical Device Rules Launched on Schedule

On January 1, 2018 the Indian government launched the Medical Device Rules as planned. The on-line SUGAM system has been converted and will now only process medical and IVD device applications under the new Rules.

All applications for product registration under the old Rules have been cleared from the system. Pending applications that were not fully processed before December 31st must now be submitted as a fresh submission under the new Medical Device Rules, 2017.

Product Registration Certificates (Form 41) or Import Licenses (Form 10) issued under the Act will be deemed valid until their expiry date or July 31, 2018 whichever is later. The DCGI does not intend to issue new Form 10 Import Licenses going forward.

Contact Asia Actual to look up the status of your medical or IVD device licenses under the old Act; or to submit new applications under the new Rules.

India Government Releases New List of Regulated Medical Devices

On November 1st, the Drug Controller General India released a Notice detailing risk-based classification of 351 medical devices and 247 IVD devices that require registration under the new Medical Device Rules 2017 going into effect on January 1, 2018.

Most of the devices are regulated currently, however, several devices are arbitrarily clubbed under existing notified device categories.  Examples include (1) infusion pumps, (2) orthodontic guide wire (3) endoscopic forceps, (4) transcervical/transabdominal endoscopes, etc.  Additionally, the device category Ablation Devices, as listed on line number 3 of the list, now includes RF generators.

This new list is similar to the draft floated on August 22, but excludes the following devices:

  1. Vacutainer
  2. Inflation device
  3. Pacing lead
  4. Enteral pump
  5. Collection bag
  6. Orthodontic bands/bracket
  7. Glaucoma drainage stent
  8. Trabeculotomy probe

All other medical devices will be added to the scope of new Rules in phases over the coming months by Ministry of Health and Family Welfare gazette notifications.

Device manufacturers are advised to conduct a careful review of the list (full document available at the bottom of the India page of the Asia Actual website) to confirm near term regulatory requirements for products marketed in India.

Asia Actual is available to assist with device registration and independent license holding service.  Please contact us with any questions or support requests.

INDIA APPLIES PRICE CONTROLS TO KNEE PROSTHESES

Yesterday, India’s National Pharmaceutical Pricing Authority (NPPA) implemented price controls for knee prostheses resulting with an average reduction of 65% from prevailing market prices. The announcement was published on August 16, 2017, with immediate effect (full document available on the India page of Asia Actual’s website).

In this Notification, Maximum Retail Prices (MRP) are specified by material of construction, intended use (primary vs. revision vs. salvage) and components used in the systems. Pricing is fixed for a period of 12 months from the date of order, until revised by further order or gazette notification. The NPPA will monitor the situation closely and may make adjustments to assure supply.

There are 14 foreign manufacturers with 30 active Product Registration Certificates that include knee systems that will be most affected. Additionally, there are 12 domestic companies with manufacturing licenses listing knee replacement systems.

Prices of orthopedic implants had been under government scrutiny since the MRP of cardiac stents were capped in February 2017.  For now, hip replacement implants, trauma implants and spinal implants will not be affected. It is expected that pacemakers, heart valves, intraocular lenses, or PTCA balloon catheters are next in line for price cap consideration.

With this action, the NPPA fast-tracked the review process by invoking a special ordinance in the Drugs Price Control Order (DPCO).  This circumvented the time-consuming deliberations by other government ministries normally required.

The market is expected to go through some rationalization in reaction to the price cuts. It is likely that some high-cost providers reducing their participation in the market. Low cost suppliers and those with high sales-channel efficiency will be greatly advantaged in this new market environment.

Asia Actual is available to help companies understand and stay compliant with the NPPA’s statutory price reporting requirements.

INDIAN GOVERNMENT REMINDS MEDICAL DEVICE INDUSTRY OF PENDING REGULATORY CHANGES

Exactly 6 months before the new Medical Device Rules, 2017 are to take effect the Drugs Controller General (India), Dr. G.N. Singh, published a notice that serves as a reminder to industry to prepare for the coming changes.

Notice number DCG(I)/Misc./2017(68) reiterates the 15 medical device categories that currently require registration under the current Drugs & Cosmetics Act, 1940.  The document appendix further delineates 462 medical devices and 250 IVD devices and accords a risk-based classification as per the new Medical Device  Rules 2017.  It is likely that these products will be subject to the new Rules on January 1, 2018.  Other medical devices are expected to be added to this list in phases starting with high risk devices and devices of special or national interest to India.

In the meantime, the DCGI requests manufacturers, importers and distributors of medical and IVD devices to adhere to the new Medical Device Rules on a voluntary basis in anticipation of their comprehensive application.

A copy of this Notice and the Rules are available on the India page of Asia Actual’s website.

India Sets Price Limits for Coronary Stents (other devices to follow)

India’s National Pharmaceutical Pricing Authority (NPPA) moved swiftly and sharply to set the Maximum Retail Price (MRP) for coronary stents at INR7,260 (US$105) for bare metal stents and INR29,600 (US$440) for drug eluting stents and bioresorbable vascular scaffolds. These are ceiling prices (exclusive of local taxes and VAT but no other charges) at which all hospitals can charge patients. The announcement was published on February 13, 2017, with immediate effect.

The market is expected to go through significant rationalization in reaction to the deeper than expected cuts with some high-cost providers reducing their participation in the market. Low cost suppliers and those with high sales channel efficiency will be greatly advantaged in this new market environment.

Effected are 11 domestic companies with manufacturing licenses listing coronary stents. Additionally, there are 22 foreign manufacturers (12 EU, 3 US, 3 Chinese, 2 Middle Eastern, 1 Singaporean and 1 Japanese) with 35 Product Registration Certificates that include coronary stent Device Master Files.

The NPPA will monitor the situation closely and may make adjustments to assure supply. Reversals of price controls are not uncommon. Since the release of the National List of Essential Medicines in 2015, 70 medicines have been removed from the ambit of price control.

While coronary stents are the first high-risk medical devices to be regulated by the NPPA, others will follow with next likely candidates being orthopedic implants, cardiac pacemakers, and intraocular lenses. The process involves the Ministry of Health and Family Welfare adding a device to the National List of Essential Medicines (NLEM). Next, the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals incorporates it onto the Drug Prices Control Order. Finally, a meeting is convened by the NPPA at which point the exact pricing structure is established. This process took less than 7 months for coronary stents.

Asia Actual is available to help companies understand and stay compliant with the NPPA’s statutory reporting requirements.

India Launches New Medical Device Regulations

Last week the Indian government officially published the Medical Devices Rules, 2017 providing for the comprehensive regulation of all medical and IVD devices in India. The Rules will come into full effect on January 1, 2018. A link to the document is available here on the Asia Actual website (the English version starts on page 143).

Key elements to the Rules are:
1. New risk based classification system (A, B, C and D) for medical and IVD devices
2. Import License requirement for all Class A, B, C and D devices going forward; initial application will be for devices requiring registration under the former Rules with new devices categories added in a rolling basis
3. Licenses already issued under the old Rules will remain valid until June 30, 2018, or license expiry whichever is later.
4. Application processing fees charged by the government will be:

Classification Type                           Plant Master File              Device Master File
Class A Medical Device                   US$1,000                             US$50
Class B Medical Device                   US$2,000                             US$1,000
Class C Medical Device                   US$3,000                             US$1,500
Class D Medical Device                   US$3,000                             US$1,500

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

5. Import Licenses do not expire with payment of a retention fee every 5 years
6. Retention fees are the same as new application fees
7. Technical data requirements are very similar to those under the current Rules

Foreign manufacturers are advised to evaluate how the new regulations apply to their product portfolio and consider early preparation of new registration applications.

Asia Actual is available for consultations and will announce guidelines as they are available.