Minutes of 82nd DTAB Meeting held at DGHS

AGENDA RELATED TO AMENDMENT OF MEDICAL DEVICES RULES (MDR), 2017

CONSIDERATION OF THE PROPOSAL TO AMEND SCHEDULE V (QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES AND VITRO DIAGNOSTIC MEDICAL DEVICES) OF MEDICAL DEVICE RULES, 2017 IN LINE WITH ISO 13485: 2016

The Board was apprised that, Schedule V of Medical Device Rules, 2017 deals with Quality Management System for Medical Devices and in-vitro diagnostic medical devices and it is largely based on requirements of ISO 13485:2003. These provisions have been updated by ISO in its third edition which is effective from 01.03.2019. Therefore, it was proposed for amendment of Schedule V of Medical Device Rules, 2017 in line with ISO 13485:2016. meeting held on 31.01.2019 & 01.02.2019 deliberated the proposal and recommended to prepare the necessary provisions or guidelines. DTAB deliberated the proposal and agreed to amend the Schedule V of the Medical Device Rules, 2017 to incorporate necessary provisions in this regard.

CONSIDERATION OF PROPOSAL TO INCORPORATE THE PROVISION FOR DETAILS OF THE COMPETENT TECHNICAL STAFF RESPONSIBLE FOR THE MANUFACTURE AND TESTING OF MEDICAL DEVICES IN FORM MD-3, FORM MD-4, FORM MD-5, FORM MD-6 FORM MD-7 & FORM MD-8 40 IN THE MDR-2017

The Board was apprised that, the Ministry of Health & Family Welfare, Government of India has notified the Medical Devices Rules 2017 vide G.S.R. 78(E) dated 31.01.2017 under the provisions of the Drugs and Cosmetics Act, 1940.Said rules are effective from 01.01.2018 to regulate the Clinical Investigation, Manufacture, Import, Sale and Distribution of the medical devices in the country.

In the said rules, it is observed that the names, qualifications and experience of the competent technical staff responsible for the manufacture, testing and evaluation of medical device(s) are not mentioned in the following forms:

1. MD-3 (Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device)
2. MD-4 (Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical Device)
3. MD-5 (Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device)
4. MD-6 (Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device)
5. MD-7 (Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D)
6. MD-8 (Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D)
7. MD-39 (Application for grant of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer )
8. MD-40 (Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer).

The details of names, qualifications and experience of the competent technical staff responsible for the manufacture, testing and evaluation of medical device(s) is not generated in licence issued to the applicants because it is not mentioned in application.

Chapter X in said rules specifies the provisions for registration of laboratory for carrying out test or evaluation. As per Rule 81, an application for grant of registration of a medical device testing laboratory to carry out testing or evaluation of a medical device on behalf of a manufacturer shall be made to the Central Licensing Authority through online portal of the Central Government in Form MD-39. The application shall be accompanied with the following information, namely:-

1. constitution of the medical device testing laboratory;
2. premises showing location and area of the different sections
3. qualification, experience of technical staff employed for testing and the person in-charge of testing;
4. list of equipment; and
5. valid accreditation certificate issued by the National Accreditation

Body for Testing and Calibration Laboratories or any other similar body as may be notified by the Central Government; As per sub rule (3) of Rule 83 of said rules, the Central Licensing Authority may grant registration in Form MD-40. However, scope of accreditation is not mentioned in MD-39 & MD-40. In view of the above, it is proposed that we may amend the form MD-3, MD-4, MD-5, MD-6, MD-7, MD-8, MD-39 & MD-40 to insert the names, qualifications and experience of the competent technical staff in the said forms and scope of accreditation in MD-39 & MD-40.

DTAB deliberated the proposal and agreed to amend the Medical Device Rules, 2017 to incorporate the names, qualifications and experience of the competent technical staff responsible for the manufacture and  testing of medical devices and scope of accreditation in respective forms.

CONSIDERATION OF THE PROPOSAL TO INCLUDE SURGICAL GOWNS, SURGICAL DRAPES AND INCISION DRAPES UNDER THE PURVIEW OF SECTION 3(B)(IV) OF THE DRUGS AND COSMETICS ACT, 1940 AS MEDICAL DEVICES

The Board was apprised that, the Ministry of Health and Family Welfare, Govt. of India has notified the Medical Devices Rules 2017 vide G.S.R. 78(E) dated 31.01.2017 under the provisions of the Drugs and Cosmetics Act, 1940. The following devices intended for use in human beings as drugs with effect from 01.01.2020, namely:

1. Nebulizer
2. Blood Pressure Monitoring Devices
3. Digital Thermometer and
4. Glucometer

Moreover, Department of Health and Family Welfare, Ministry of Health and Family Welfare vide G.S.R. 775 (E) dated 08.02.2019 In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board has the following devices intended for use in human beings as drugs with effect from 01.04.2020, namely:

1. All implantable medical devices
2. CT scan Equipment
3. MRI Equipment
4. Defibrillators
5. Dialysis Machine
6. PET Equipment
7. X-Ray Machine and
8. Bone marrow cell separator

In addition to these initiatives, the Central Government under the chairmanship of DGHS w.r.t. the implementation of the decisions taken by Committee of Secretaries on Technical Textiles, it is proposed that surgical gowns, surgical drapes can be considered for notification under the said act in the meeting convened by the South India Textile Research Association (SITRA) on 05.10.2018 at Nirman Bhawan, New Delhi.

In this connection, a public notice was uploaded on CDSCO website on dated 27.11.2018 for the aforesaid matter and requested all the stakeholders to forward their comments/ suggestions within 45 days of the issue of this public notice. Further, a meeting was held on 27.03.2019 for the regulation of surgical drapes and surgical gowns under the Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 wherein stakeholders were agreed for the regulation of said products.

Therefore, it is proposed to regulate the surgical gowns, surgical drapes and incision drapes under the said Act. DTAB deliberated the proposal and agreed to notify surgical gowns, surgical drapes and incision drapes under the Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940.

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CONSIDERATION OF THE PROPOSAL FOR THE PREPARATION OF ROAD MAP ON THE REGULATION OF ALL MEDICAL DEVICES IN A PHASE WISE MANNER ALONG WITH THE MANPOWER REQUIREMENTS

DTAB was apprised that, currently 23 categories of medical devices are regulated under the provisions of Drugs and Cosmetics Act, 1940. Representations have been received from various stakeholders for regulating all non-notified medical devices since concerns have been raised from time to time in different fora regarding safety, quality and performance of various Medical Devices including diagnostic kits manufactured/imported in the country. Many of the Medical Devices like equipment, analyzers, instruments etc. used in various health care facilities for diagnosis, treatment, mitigation are currently out of scope of regulation under Drugs and Cosmetics Act. Keeping in view the need for such comprehensive regulation of all medical devices, Ministry of Health and Family welfare, had constituted a committee vide order No.11035/61/ 2019-DR dated 04.02.2019. The committee after deliberations with industry stakeholders and concerned departments has submitted its report. The recommendations of the committee are as follows:

All medical devices should be regulated in Drugs and Cosmetics Act, 1940 in a phase wise manner as following:

In the first phase, all manufacturers and importers of all non-regulated Medical Devices should register the details of the devices manufactured/imported by them in a special SUGAM portal to be developed for this purpose and a notification should be issued under the Act in this regard as proposed in the report. Such registration should be initially on voluntarily basis up to 18 months from the date of notification and thereafter, it should be made mandatory for all importers and manufacturers in the country.

During this phase, all manufacturers and importers should report the Serious Adverse Events (SAEs) to CDSCO as well as Materiovigilance Programe of India (MvPI) so that these reports could be analysed to assess the safety and performance of the devices and take appropriate regulatory interventions to ensure patients safety.

Similarly cases of complaints on such devices regarding failure in Quality Management System, design, product quality etc., should be reported to CDSCO for appropriate investigation and regulatory actions to ensure quality, safety and performance of the Medical Devices marketed in the country.

In the second phase, registration of Class A & B devices shall be followed by mandatory licensing within 12 months after 18 months of registration period is over i.e. for manufacture, import and marketing of all low risk Medical Devices falling under Class A & Class B, notified under 1st phase, requirement of prior license under Medical Devices Rules, 2017 should be made mandatory within 12 months after implementation of provision of registration under phase one. After the 12 months period, no person, company, organization should be allowed to manufacture, import, sale or distribute Class A & Class B Medical Devices without prior license under the Medical Devices Rules, 2017.

In the third phase, registration of Class C & D devices shall be followed by mandatory licensing within 24 months after 18 months of registration period is over i.e. all high risk Medical Devices falling under Class C & D notified under 1st phase, requirement of prior license under Medical Devices Rules, 2017 should be made mandatory within 24 months after implementation of provision of registration under phase one. After the 24 months period, no person, company, organization should be allowed to manufacture, import, sale or distribute Class C & Class D Medical Devices without prior license under the Medical Devices Rules, 2017.

The committee has proposed draft notification along with exemptions in this regard which are elaborated below:

“In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940(23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings for the purposes referred to in the said sub-clause as drugs from 18 months after the date of this notification”

“All Medical Devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assisted in its intended function by such means for one or more of the specific purposes of,-

1.  diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
2.  diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
3.  Investigation, replacement or modification or support of the anatomy or of a physiological process;
4.  supporting or sustaining life;
5.  disinfection of Medical Devices;
6.  control of conception;’’

Further, since this notification will cover all the Medical Devices, the provisions in MDR, 2017 will be automatically applicable to them without individual or class notification which is not the proposed transition scheme by way of registration. Therefore, an exemption needs to be given for obtaining license for import, manufacturing, clinical investigation and performance evaluation permission, test licence of such devices which would be first registered only, as mentioned above.

The exemptions can be given in the Rule 90 of MDR, 2017 by making amendment (addition to the Rules) as following:

• Class of Medical Devices Extent and Condition of Exemption
• All devices notified as per definition under section 3b (iv) of Drugs & Cosmetic Act. Except those which are already notified or regulated presently Provisions of Medical Devices rules
• To obtain license for import/manufacturing for sale or for distribution
• To obtain permission to conduct clinical investigation or clinical performance evaluation.
• To obtain permission to import or manufacturing for sale or for distribution of medical device/ new in-vitro diagnostic medical devices which do not have predicate medical device.
• To obtain license for import/manufacturing for the purpose of clinical investigation, test, evaluation, examination, demonstration or training.

These exemptions are valid for medical devices of Class A & B upto 30 months and for medical devices of Class C & D upto 42 months from the date of notification of these exemptions.

Provided such device shall be registered with CDSCO on the special SUGAM online portal and shall bear the registration number issued by CDSCO to manufacturer or importer as per the procedure laid down in the guidelines issued by the CDSCO ” Procedure for registration of such medical device and surveillance mechanism shall be as following: •

To import or manufacture of such devices, the applicant will upload information and data as specified in the special SUGAM portal to obtain Registration.

•  Documents to be uploaded in the portal includes:-
•  Details of the manufacturer or importer and his products.
•  Certificate of compliance with respect to ISO 13485 standard accredited by NABCB/IAF.
•  Legal undertaking stating that device is complying with all relevant standards as per Rule 7 of Medical Devices Rules, 2017 and all documents including ISO 13485 Certification submitted by the applicant are true and authentic.

Once applicant submits above information on special SUGAM portal, Registration will be generated which shall be printed on label by the manufacturer or importer. CDSCO shall verify the documents at any point of time and investigate quality/safety related failure/complaints and suspend/cancel the registration based on the findings/outcome of verification/investigation, after giving an opportunity to show cause to the registrant.