Date: 04.02.2017 To, Shri Chandra Kishore Mishra, Secretary, Ministry of Health & Family Welfare Nirman Bhawan, New Delhi (Email : [email protected]') Kind Attn: Shri. Chandra Kishore Mishra Subject: Comments on Medical Device Rules 2017 GSR 78 (E) Notified on 31-01-2017 Respected Shri Chandra Kishore Mishra ji, We have studied the above document and thank you for considering some of our recommendations made on the draft rules through our letter dated 27/12/2016. We are however dismayed that a golden opportunity to accelerate manufacturing of Medical Device Industry is being lost and to note that most of our recommendation including the five strategy point have not been considered at all, which were raised in the meeting with you and Joint Secretary, Shri K L Sharma ji on 06/01/2017. Status of consideration of each of our recommendations w.r.t. the subject notification is given below The recommendations which have Not been considered and incorporated in above notification have been indicated as “Not considered” in Red. Whereas the recommendation which have been considered and incorporated have been indicated as “considered” in Green. We request you to kindly review and incorporate our suggestions by issuing an Amendment at the earliest or advice us which will be addressed in proposed Medical Device Bill so that we will strike these off this list and not bother you for these for now. If these for #12, 19, 20 & 21 we have been assured correction by Joint Secretary (Regulations) at the time of Review of Schedule M III and then again for Draft Rules (27th December version) during every review Meeting. AIMED Recommendations A. Specific Comments: 1) Re: Question: Who will the Indian National Medical Devices Regulator Regulate? Answer: The currently proposed Regulatory Framework proposes CDSCO (& SLA) to continue to regulate the Manufacturer, CDSCO for the Importer and to delegate the Regulation of Trading Company to the State Licensing Authority. Our Proposal, in Line with the Japanese Regulatory System, is as follows The CDSCO should regulate the Importer, the Manufacturer (and the specific Manufacturer Site) and the Market Access Authorization Holder (whether the MAAH is the Manufacturer or Marketing Company or an Authorized Agent of the Overseas Manufacturer) and the SLA regulates the Domestic Reseller – Wholeseller OR Retailer OR Healthcare Provider. Not considered, (Against Make in India) 2) What will be regulated to ensure patient safety? Answer: Only Devices notified as drug will be regulated. Devices which are not notified will be encouraged to go for ICMED certification. For manufacturers who have got ICMED Certification, on getting Notified, the ICMED Certification needs to be recognized and there should then be no need to have a premarket mandatory audit by another Notified Body. This provision should be added at the end of rule 20. Not considered (Against Make in India & Ease of Doing Business) 3. Reference Rule 1 These rules shall come in force w.e.f. 01/01/2018 (unless specified otherwise) We would suggest a transition period of minimum 2 – 3 years should be given for capacity building for implementing these rules without a procedure for Registration and announcing any Notified Bodies, to register / license 1000 Manufacturers in 225 days is farfetched and target. Not considered (an inadequate transition period of only 11 months has been given) 4) Reference Rule 3: Definitions: Definitions of Sub-Contractor, OEM, OBL, and Pseudo Manufacturer are still missing. We would suggest to include provision in Rules for ‘Market Access Authorization Holder’. The proposed definitions are as follows. We would suggest to include these definitions in Rule 3 (i) Market Access Authorization Holder: A Marketing Company authorized by the CLA to sell the Product in Indian Market who himself manufactures the Medical Device and includes any other Person who undertakes such manufacturing activity on his behalf under his own Label or Brand. It is responsible for all Post Market Surveillance activities. Explanation: for the purpose of these rules, the Person who has marketed or promoted any Medical Device or used any other similar expression printed, written, embossed, stickered or put in any manner on the Medical Devices shall be construed as applicant for being Market Access Authorization Holder (MAAH). (ii) Sub-Contractor: Means a person or a company hired by a Manufacturer to perform a part of manufacturing process ( by a Manufacturer) or the whole manufacturing process (by a Market Access Authorization Holder). (iii) OEM: Original equipment manufacturer: A person or a manufacturing organization hired by a Market Access Authorization Holder to perform the whole of the manufacturing process on his behalf. (iv) OBL: Own Brand Labeler: Market Access Authorization Holder who purchases a finished Medical Devices from the Original equipment manufacturer (OEM) and then places on the market under his own name or trade mark (Brand). (v) Pseudo Manufacturer: A Seller having the pretended or false appearance of manufacturer though actually not producing by himself. (Manufacturer is a person, an enterprise, or an entity who himself makes a product through a process involving raw materials, components, or subassemblies, usually on a large scale with different operations divided among different workers. Additionally it fulfills the condition of required Value Addition of minimal 45% and change of Tariff Sub Head (CTSH) of input for enabling Substantial Transformation to produce Output). Not considered (Against Make in India) 5. Reference Rule 3 (f) The term and definition of Authorized Agent should be replaced by the term and definition “Market Access Authorization Holder”. Not considered 6. Reference Rule 3 (z) The definition of Loan license should be modified to clarify the actual status. Our proposed definition is – “Loan license” means a license to be issued for manufacturing of a medical device by the State Licensing Authority or the Central Licensing Authority , as the case may be, to a person who is a licensed manufacturer of a medical devices who intends to utilize the manufacturing site of other licensee for same medical device. Considered (Thank You) The definition has been modified as “loan licence” means a licence issued for manufacturing a medical device by the State Licensing Authority or the Central Licensing Authority, as the case may be, to a person who intends to utilise the manufacturing site of other licencee for manufacturing the same medical device as manufactured by the licencee at that site; 7. Reference Rule 4 (3) This rule specifies that Central Licensing Authority shall classify the Medical Devices. We would like to suggest that this is the manufacturer who should classify the Medical Devices and provide the justification for such qualification, based upon the parameters specified in first schedule. Not considered (Against Ease of Doing Business) 8. 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. Not considered (Against Make in India & Ease of Doing Business) 9. 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. Not considered (Against Make in India and Ease of Doing Business) 10. Reference Rule 26 (x) The requirement to supply package insert or user manual with the Medical Device, to be qualified by “where appropriate” as package insert or user manual is not required with all the Medical Devices. Considered (Thank You) The requirement qualified by “wherever applicable”. 11. Reference Rule 44 (e) This rule requires “the month of manufacture and date of expiry to be marked on the label” the month of manufacture is not correct representation it should be corrected as date of manufacture which is to be printed in terms of month and year of manufacturer or expiry. Considered (Thank You) Corrected 12. Reference Rule 44 (o) i) The information’s required should be preprinted on the label in case of imported devices and not after import by the way of stickering Not Considered (Against Make in India) ii) The provision to mark limited information’s necessary for device identification and safe use (i.e. information’s covered by sub clause a,b,e,g & k) in case primary pack is of small size has been deleted. This provision was added after detailed deliberations and discussions with the stake holders. We would suggest that this provision should be included. The new clause # is 44 (o) The provision included but requirements of sub clause c, d & m also added which are again difficult to include on small pack. (Against Ease of Doing Business) 13. Reference Rule 47 This Rule permits import of Medical Devices having Residual Self Life as low as 40%. We would strongly recommend that any Medical Device having less than 2/3rd Residual Self Life should not be allowed for import. Not Considered (Against Make in India) 14. Reference Rule 79 The term adulterated is not appropriate for Medical Devices, so this should be deleted. Not Considered (Against Make in India & Ease of Doing Business) 15. Chapter X should be corrected as chapter XI and Chapter XI should be corrected as chapter XII (for correct serialization) Considered (Thank You) Corrected 16) Reference First Schedule Part I: Classification of Medical Devices other than In vitro diagnostic Medical Devices: We have noted that the Rules seem to be based on GHTF Guidelines. (with language modified) whereas the classification rules circulated with earlier draft were as per European Directives. The rules in EU Directives & GHTF Guidelines are not significantly different but the language in EU Directive is simpler. We would suggest that classification rules based upon EU Directives should be adopted and examples for each of the applicable rules should also be included. A comparison of classification rules as per EU Directives, GHTF Guidelines & Draft Medical Devices rules 2016 is enclosed as appendix -2 Not Considered (Against Ease of Doing Business) 17) Reference Third Schedule Part II 1: Requires “the specific application (to perform the audit of manufacturer who applied under sub rule (i) of rule 20) shall be allotted to the Notified Body by the portal of the Central Government”. A provision is needed in case a manufacture, who has Quality Management System Certification from a Notified Body other than the one allotted by the portal of the Central Government. It would not be practical for any manufacturer to get audited by two different Notified Bodies. Provision needs to be made for option of acceptance of alternative Accredited CB in the NB List and recognition of ICMED Certification. 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 Accridited Notified Body for the Compliance with IS / ISO 9001 should suffice and there will be no need to demonstrate Compliance with fifth Schedule. Not Considered (Against Ease of Doing Business) 18) Reference fifth Schedule Cl. 3.6: Raw material has been included in the definitions of component which is not correct in context of medical devices. We would suggest that component and raw material should be defined separately. We would like to suggest following definitions. -Raw Material: A material that is chemically and /or physically transformed to become a Component or part of a Component. - Component: A piece, assembly or software which is intended as part of the finished, packaged and labeled device. These definitions should be shifted to Rule # 3 Not Considered (Against Ease of Doing Business) 19) 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. Not Considered (Against Ease of Doing Business) 20) 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. Not Considered (Against Ease of Doing Business) 21) Reference fifth Schedule Annexure A (Environmental requirement for Medical Devices and in Vitro Diagnostics) : We would suggest to add following note at the end of Annexure –A Note: The Intermediate processes like Blanking, Machining, Polishing, Buffing &Trimming etc For these Devices or any other Devices, which generates dust, can be performed inz ventilated area. Not Considered (Against Ease of Doing Business) 22) Reference Sixth Schedule: Changes in labels, manufacturing process, equipment or testing and primary packaging material have been included in the list of major changes which needs prior approval from the competent authority. In this regard we would like to suggest the following: Changes in labels: In any case the label has to meet the requirement of chapter – VI Changes in manufacturing process, equipment or testing: As per fifth schedule (Quality Management System) a manufacturer has to validate any change in manufacturing process equipment or testing method prior to adoption. Changes in primary packing material: As per fifth schedule (Quality Management System) a manufacturer has to validate any change in primary packing material. The validation includes packing process as well as packing material. As all the above changes have to be validated prior to adoption by the manufacturer there is no need to get prior approval from competent authority. Such changes can be evaluated by the notified body or licensing authority at the time of their audit. We would like to suggest that above changes should be deleted from the list of major changes. Not Considered (Against Ease of Doing Business) B) Missing Rules: 1) Provision for Rules for Packing or Repacking of Medical Devices and In-Vitro Diagnostic Devices related to manufacture of Medical Devices and In-Vitro Diagnostic Devices have not been included in Draft Rules. Our Proposal is enclosed in Appendix -1. 2) We would suggest the Rules (or Schedules) may be framed to also cover the following: (i) Responsibility for Market Access Authorization Holder (ii) Responsibility of BIS (iii) Responsibility of Reseller – Hospital (iv) Responsibility of User (v) Rules for Market Access Authorization Holder (vi) Rules to Discipline & Penalize (vii) Rules for Grievance Handling, Tribunal etc. (xiii) Rules for Advertising & Claiming Performance (ix) Rules for Restricting Reuse of Single Use Medical Devices (x) Rules to Issue “Free Sale Certificate” (xi) Rules to Ban / Restrict Import of Preowned / Refurbished Medical Devices (xii) Rule to ensure labelling of Country of Origin on Unit Pack of Sale Not Considered The above status clearly shows that a majority of the recommendations from Indian Medical Device Manufacturer that we had collated and submitted on their behalf remained unaddressed in the subject document. We would strongly recommend review of the document and suitable amendment, and for permitting a transition period of minimum two years for Medical Devices other than IVD, for IVD it may be three years. Thanks & Regards, Rajiv Nath Forum Coordinator Association of Indian Medical Device Industry (AiMeD) GL-3, Ashoka Estate, 24, Barakhamba Road, New Delhi - 110 001 Ph. +91-129-4289000/4061151 Fax. +91-129-4061164 & 2233242 E-mail : [email protected] Web : www.aimedindia.com mt CC, Shri. K L Sharma, Joint Secretary (H) MOH&FW, Email : [email protected] Dr. G N Singh – DCGI, CDSCO, (E-mail : [email protected] ) Dr. Eswara Reddy, Joint Drug Controller (India), CDSCO, Email : [email protected]
Copyrights 2009. Association of Indian Medical Device Industry.