To Sh. Dinesh Singh , Additional Director , Rajya Sabha Secretariat , Parliament House Annexe Extension Building

Dear Sir,

IMA (Indian Medical Association) is the largest scientific body comprising of around 2.77 lacs members, doctors of modern system of medicine across 1725 branches in all States & UTs across the country. IMA is working in line with National Health Policy 2017 for affordable, universal and accessible quality healthcare. IMA supports self-regulation for Healthy Profession for Healthy Nation.

IMA congratulates the Parliamentary Standing Committee on Health and Family Welfare headed by Prof. Ram Gopal Yadav, M P Rajya Sabha for examining the Medical Devices Rules 2017, in line with best international practices.

IMA committee on the above subject has gone through the “Medical Devices Rules 2017 document and is submitting the concerns observed as below for your considerations:

1.Medical Devices Rules 2017 are presently framed under Section 12 and section 33 of the  Drugs & Cosmetic ACT 1940 (23 of 1940). Medical devices are quite different from Drugs in development, manufacturing, material and its use and action on human body  and hence requires a separate act to be regulated by a separate body different from CDSO having adequate knowledge, skills, expertise and resources to deal with medical devices sector efficiently.

2.A general definition of a medical device as given by WHO may be included in rule 3   “Definitions” 

“Medical Device” means any instrument, apparatus, implement,

machine, appliance, implant, in vitro reagent or calibrator, software,

material or other similar or related article intended by the manufacturer to be used,   alone or in combination, for human beings for one or more of the specific purpose(s) of:

_ diagnosis, prevention, monitoring, treatment or alleviation of disease,

_ diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

_ investigation, replacement, modification, or support of the anatomy or of a  

    physiological process,

_ supporting or sustaining life,

_ control of conception,

_ disinfection of medical devices,

_ providing information for medical or diagnostic purposes by means of in vitro  

    examination of specimens derived from the human body;

3. To promote “Make in India” and for international business ease, incentives for indigenous manufacturing and some filtering mechanism for import should be included in the rules.

4.Reference Rule 4,

 Central Licencing Authority shall classify medical devices in consultation with technical    group comprising of various stakeholders. Task force needs to be created specialty wise for the purspose.

5. Ref. Rule 7

     Device specific BIS technical standards to be made available for all devices

6. Reference Rule 20 (1)

This rule specifies that manufacturing license will be required from State Licensing Authority for the Manufacture of Class A & Class B Medical Devices. Whereas as per earlier draft Class A Medical Devices were to be self-regulated with simple online registration (this provision was added after detailed deliberations and discussion among the stake holders) we would suggest that provision of self-regulation with simple online registration for Class A Devices should be retained and no need for applying for a Manufacturing License.  

7.Reference Rule 20 (4) (ii) 

For a Manufacturer making Class A Medical Device Compliance with fifth Schedule will be very difficult and unwarranted. We would suggest that for Class A Manufacturer a Certification from a Accredited Notified Body for the Compliance with IS / ISO 9001 should suffice and there will be no need to demonstrate Compliance with fifth Schedule.

8.Ref. Rule 23,

Identified Third party Auditors to be used for inspection of manufacturing sites  as  requirement for grant of license.

Regulators should not carry out inspection (s) themselves, inspections shall be entrusted to a third party independent agency(s) in all circumstances where inspection is to be done. This will bring in the necessary technical expertise and negate the possibility of corruption.

9.Reprocessing of single use device (SUG)/Restrictive Reuse of Device (RRD)

The reprocessing of expensive SUDs is common worldwide. Even in developed nations, including those that have reprocessing prohibitions in place, hospitals routinely reuse SUDs. In India also, reprocessing of expensive devices is universal at hospital level.

Scenario is changing, reprocessing if regulated shall have positive impact on health economics by making

1. healthcare affordable
2. Reduction in toxic  biodegradable waste generated by disposing medical devices thus positive impact on  environment also.

A regulated reprocessing with informed consent and price benefit to patients should be permissible especially in limited resource setting. Hence rules may framed accordingly.

(Literature as support documents are attached)

10.Ref rule 46

      …..    unique device identification which shall contain device identifier and production identifier.

Explanation.— For the purposes of this rule,-

(i) “device identifier” means a global trade item number;.

(ii) “production identifier” means a serial number, lot or batch number, software as a medical device version,

manufacturing and or expiration date.

This may not be feasible in existing scenario, and should be deleted.

11. Reference Rule 47

This Rule permits import of Medical Devices having Residual Self Life as low as 40%. 

We would strongly recommend that Medical Devices should have Residual Life as below for import:

General Devices          70%

Implantable Devices   90%

Diagnostic     Devices  66%

Devices having    Residual Self Life less than as above, should not be allowed for import.

12. Ref. Rule 53

 ….  A separate Registry for Clinical Investigations   in respect of Medical Devices

       should be developed

13. Under chapter VII  Clinical investigations under rule 55

       Provision for penalties should separate from that of as given under 122DAB as risk arising out of clinical investigations for medical device are different from that of drugs, needs discussion further with stakeholders.

14. under Rule 70,regarding    inspections by a medical device officer once in a year these inspections may conducted by a identified third party auditors, may be once in 2 yearsor on complaint basis serious in nature, when ever received.  Inspection (s) on complaints basis to be done unannounced.

15. Reference fifth Schedule Cl. 4.2.1 (e) :

There is requirement to maintain a file “for each type or model of medical device”. There is also a requirement to maintain a “Device Master File”. Contents of Device Master File have been details in appendix - II of Fourth schedule.

In the regard we would like to clarify that most of the contents of Device Master File and file required to be maintained for each type or model of medical device (generally called as Technical File) are common. So requirement to maintain two separate files will only be duplication and will create confusion. We would like to suggest that requirement to maintain only one of these files be retained.

16.Reference fifth Schedule Cl. 4.2.2 : 

There is requirement for a manufacturer to maintain a Quality Manual and a Plant Master File .The contents of Plant Master File have been detailed in appendix - I of Fourth schedule. In this regard we would like to inform that Quality Manual itself includes most the requirements of  “Plant Master File”

We would suggest that Plant Master File should contain the additional requirements only which are not there in the Quality Manual, to avoid duplication and confusion.

17. After sale service

There is no provision for after sale service

To bring in transparency and accountability of the manufacturers and stakeholders, rule(s) for after sale support for maintenance of the equipment/device should be added.

18.IMA is to suggest that on lines of NLEM, a National list of Priority Medical Devices (NLPMD) should be framed to facilitate Price Control Mechanism for affordable priority devices.

19. Missing Provisions:

We would suggest the Rules (or Schedules) may be framed to also cover the following:

• Responsibility for Market Access Authorization Holder and Pseudo-manufacturer to be banned.
• Responsibility of BIS
• Responsibility of Reseller – Hospital
• Responsibility of User (Doctor/Health Technician/Home user)
• Rules for Market Access Authorization Holder
• Rules to Discipline & Penalize
• Rules for Grievance Handling, Tribunal etc.
• Rules for Advertising & Claiming Performance 
• Rules to Ban / Restrict Import of Preowned / Refurbished Medical Devices

20. Presently, only 23 devices notified as drugs shall be regulated under these rules.IMA is to suggest some kind of certification by a identified certification body being envisage for rest   of medical devices i.e  Quality Council of India (QCI) has launched a voluntary certification scheme (ICMED)  an joint initiative of industry and QCI. This certification shall facilitate subsequent approvals of competent authority where ever applicable.

Dr Ravi S. Wankhedkar                                                                                      Dr R N Tandon

National President                                                                         Honorary Secretary General

Indian Medical Association                                                              Indian Medical Association