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Indian Certification Of Medical Devices Scheme (ICMED)

“ICMED”- a first home developed international class certification scheme for medical devices in the country is the joint initiative of Association of Indian Medical Device Industry (AIMED) and Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB). “ICMED” is aimed at enhancing patient safety, to provide enhanced consumer protection along with product credentials to manufacturers for instilling confidence among buyers and users.

For manufacturers, it aims to bring down the substantial time and cost-run to obtain globally accepted quality certification and eliminate the malpractices of sub-standard or fraudulent certification or quality audits.“The scheme fills a big regulatory vacuum in quality certification space for medical devices in the country & will enhance the competitiveness and profitability of Indian medical device industry,” said Dr. V. K. Subburaj, Secretary, Dept. of Pharma, GoI.

“The Scheme is a significant milestone for both consumers as well as manufacturers as it brings quality, accountability and competitiveness and in due course will also bring respect to Brand India for those carrying this certificate,” said Mr. Rajiv Nath, Forum Coordinator, AIMED & Chairman, Technical Committee, QCI AIMED Voluntary Initiative on Medical Devices.

The Certification Scheme being launched has presently two options for certification, one ‘ICMED 9000 Certification (an ISO 9001 plus additional requirements)’ for low risk medical devices and other ‘ICMED 13485 (An ISO 13485 Plus additional requirements) for medium and higher risk devices. A third level, which would additionally prescribe medical device specifications developed by NHSRC, Ministry of Health and Family Welfare is still under development and would be launched later.

According to Dr. M. K. Bhan, former Secretary to the Govt. of India, Dept. of Biotech, Ministry of Science & Tech., for a country like India, the twin challenge is to ensure availability of quality healthcare products at reasonable cost In this direction, the launch of “ICMED” is a significant collaborative initiative & will ensure realization of these objectives”. “QCI is happy to lend a helping hand to the medical device industry to showcase its strength in terms of meeting the highest international standards. It would contribute to the success of govt’s flagship Make in India program, ”said Mr. Adil Zainul, Chairman, QCI.

“NABCB is accrediting certification and inspection bodies and its accreditation programmes are internationally equivalent placing it on par with European and American accreditation bodies. This equivalence would help facilitate acceptance of “ICMED” certification in overseas market,”said Mr.Anil Jauhri, CEO, NABCB.

The manufacturers would need to approach any one of the certification bodies approved by QCI under the Scheme for obtaining certification. The certification bodies shall be under the oversight of NABCB, which would accredit these certifying bodies as per applicable international standards. The certification scheme is open to both indigenous and foreign manufacturers.

“ICMED” is the fructification of a MoU signed between QCI and AIMED on 30 Oct 2014 to fill the regulatory vacuum in quality certification space for medical devices in the country. The scheme has been developed involving various stakeholders with a Steering Committee chaired by Dr. M.K. Bhan, supported by a Technical Committee and a Certification Committee constituted for this purpose. More than twenty govt. and non-govt. organizations participated in various committees.

Amendment Of Drug Rule 76 To Delink Medical Devices From Pharmaceutical
And Revision Of Schedule MIII And Its Alignment With IS/ISO 13485 Notified

In the notification dated March 29, 2016, Ministry of Health and Family Welfare (Dept. of Health and Family Welfare) has issued draft rules to amend the Drugs and Cosmetics Rules, 1945 for which objections and suggestions are invited.

The words Schedule M and Schedule M III are replaced by Schedule M relating to pharmaceuticals products and Schedule M-III relating to Medical Devices and In-Vitro Diagnostics.

The Highlights Of The Draft Rules Are:

• The provisions of this schedule shall be applicable to manufacturers of finished Devices, in-vitro Diagnostics, mechanical contraceptives (condoms, intrauterine devices, tubal rings), surgical dressings, surgical bandages, surgical staplers and ligatures, blood and blood components (collection bags, intended for human or animal use and manufactured in India).

• Finished Devices means any Device or accessory to any Device that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized.

• In-vitro Diagnostic means in-vitro diagnostics referred in this Schedule including diagnostic kits and reagents that fall under sub-clause (i) of clause (b) of section 3 of Drugs and Cosmetics Act, 1940.

• Medical Device referred in this Schedule means Devices that are notified under clause (iv) of sub-section (b) of section 3 of Drugs and Cosmetics Act, 1940.

• Regarding the work environment condition the Schedule has specified requirements for the following products: Cardiac Stents/ Drug Eluting Stent, Heart Valve, Intra Ocular Lenses, Bone Cements, Internal Prosthetic Replacement, Orthopedic Implants and Catheters/ I V Cannulae/ Scalp Vein Set.
  
  The detailed report is available at ( http://www.cdsco.nic.in/writereaddata/GSR%20357(E)%20dated%2029_03_2016.pdf )

Medical Devices With BIS Certification Is In Vogue With The “Make-In-India” Policy: DGAFMS, Ministry Of Defence

• BIS 13485 certification is accepted equivalent to US FDA and CE for QMS Compliance.

• Formal recognition by Defence, not to keep USA FDA as exclusionary.

The Director, General-acquisition, Ministry of Defence has intimated that for technologically sensitive products or devices on which the life of the patient depends, it is the endeavor to procure the best product available globally which satisfy stringent norms for the device quality and patient safety. In the large interest of the patient and to administer or provide the best available treatment modalities, the equipment are required to be either USFDA or European CE or BIS certified. The item may be certified by any of the above certification agencies and not mandatorily by USFDA or European CE.

The qualitative requirements are prepared so as to generate maximum competition among the vendors to avoid single tender situation.

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