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The medical devices industry has raised concern over the Department of Health and Family Welfares' draft notification introducing fee for test or evaluation of medical devices and mandating inclusion of licence number of sub contractor on the product labels.
The Department published the draft notification on April 10, proposing various amendments to the Medical Devices Rules (MDR), 2017 including introduction of fee for test or evaluation of 11 types of tests or evaluation. The prescribed cost of the test or analysis shall automatically increase by five per cent annually.
The Association of Indian Medical Device Industry (AiMeD), an Umbrella Association of Indian Manufacturers of Medical Devices covering all types of medical devices including consumables, disposables, equipment, instruments, electronics, diagnostics and implants, representing the interest of over 1,200 manufacturers, said that the unilateral implementation of testing fees has risks involved.
"Unilateral implementation without consulting NABL-accredited labs (BIS/ISO standards) risks unsustainable models for quality testing," said Rajiv Nath, forum coordinator, AiMeD.
"With over 6,000+ in scope, controls must be risk-proportionate-rigorous for high/moderate high-risk. Focus efficiency on high-risk devices, not overburden low/moderate low-risk segments", he added. The draft is absent from CDSCO website, limiting participation from the industry in terms of submitting suggestions. The Association sought the Department to conduct consultations on the measure before further proceedings.
According to the notification, the cost of test of medical devices include implantation test proposed at Rs. 5,000, surgical sutures at Rs. 3,000, sterility test and physical tests or physiochemical test for perfusion sets etc., at Rs. 2,000, and surgical dressings and syringes and needles at Rs. 1,000.
Tests for optical rotation, specific gravity, refractive index, weight per ml, fluorescence etc., require a fee of Rs. 250 each, while absorbency, weight per unit area (surgical), foreign matter, extractive value, threads count, length & width (surgical), surface active substances, acidity or alkalinity, neps, setting time etc., will attract a fee of Rs. 150 each.
Tests for condoms and intrauterine devices have been proposed at Rs. 2,500, while the qualitative test for bacterial endotoxin is proposed at Rs. 3,000 and quantitative test for bacterial endotoxin at Rs. 4,500, according to the draft notification.
"For test/evaluations not specified in the above table, charges shall be determined by the director or medical device testing officer of the laboratory/institute as the case may be," said the draft notification.
The draft amendment also proposes inclusion of provisions to mandate that the application forms under rule 69 should be accompanied with a fee specified in the ninth schedule.
The draft also proposes to insert a provision under Rule 44, that in case of a medical devices manufacturer outsources sterilisation process, the license number of the sterilisation site should be mentioned on the label of the device.
Commenting on the proposal, Nath said, "Mandating license numbers on product labels creates a 'significant barrier', delaying exports by 3-4 weeks during downtime at Gamma Radiation subcontractor". The Association recommended limiting the decision to shipping cartons or batch records for traceability and supply chain flexibility. "No global regulator imposes such restrictions," added Nath.
He requested the Department to clarify equitable applicability of the provision to Indian as against overseas manufacturers or importers. He reiterated that the focus should be shifted from low-risk to high-risk devices. "AiMeD calls for self-regulation, transparency, and balanced oversight," he averred.
The draft notification also proposes amendment of certain definitions under the Rule 3 of the MDR, to include definition of certificate of registration, in addition to the existing definition of license.
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