Asia Regulatory Roundup: India to Limit Use of Imported Devices

Regulatory NewsRegulatory News | 20 March 2018 |  By 

Stories in this roundup focus on India establishing guidelines for grouping device applications and Malaysia creating a regulatory pathway for equipment manufacturers.
India to Limit Use of Imported Medical Devices by Public Programs
The Indian Department of Pharmaceuticals (DoP) is planning to limit the proportion of medical devices public programs can source from foreign manufacturers. DoP’s proposals build on a broader document released last year to promote the “Made in India” campaign.
That 2017 document forced public programs to prioritize local companies, either by cutting foreign businesses out of the tendering process entirely or capping the proportion of the contract they could win. DoP’s draft document reiterates these positions, with some minor tweaks, while proposing caps on the use of imported products by public healthcare programs.
DoP has tailored the caps to different sectors. The government agency wants public programs to procure at least half of their medical disposables and consumables and 40% of their implants from local manufacturers. Foreign companies will retain as much as 75% of the public markets for medical electronics, hospital equipment, surgical instruments and diagnostic reagents. 
Those figures, which were set after talking to the industry, may change once DoP completes a review of the capacity of the local industry to supply public programs.
DoP has opened the guidelines up for a 21-day comment period.
Draft Guidelines
India Establishes Guidelines on Grouping of Medical Device Applications
The Indian government has released guidelines detailing when and how companies seeking clearance to import or manufacture medical devices can group products in a single submission. The document supports the introduction of the Medical Devices Rules, 2017.
In the guidance, the government states that applicants can group medical devices with “similar intended uses or commonality of technology” into single submissions in certain circumstances. Depending on the details of the collection of medical devices, the products will fall into one of six categories that dictate their regulatory status.
For example, the developer of an in-vitro diagnostic (IVD) kit can seek regulatory approval for the reagents and articles used in the test through a single submission. Once the kit is approved, the company can supply the reagents and articles as replacement items without seeking regulatory clearance for each item individually. However, analysers and other instruments needed to perform the test cannot be covered by the single application.
Different rules apply to other collections of medical devices. A company can package bandages, gauzes, drapes and thermometers into a first aid kit and win approval for all of them through one application as they are treated as a “group.” The clearance only covers the devices when sold together as a first aid kit, though. To sell a thermometer or other item individually, the company would need to seek a separate approval under the single medical device classification.
Other categories defined in the guidance include IVD clusters, families and systems. The characteristics of these groupings overlap, but the guidance notes defining distinctions that have implications for their regulatory status. For example, devices of the same risk classification can be grouped as a family. If the devices do not meet this criterion, they may be grouped as a system.
Device Guidelines
Malaysia Creates Regulatory Pathway for Original Equipment Manufacturers
The Malaysian Medical Device Authority (MDA) has established a regulatory pathway for original equipment manufacturers (OEMs) that want to market their products globally. The pathway resolves an issue with the Medical Devices Act that left OEMs beyond the scope of the rules.
OEMs make medical devices to be sold by other companies. The characteristics of such companies put them outside the definition of a medical device business established in Malaysian legislation on the sector. As such, OEMs have been unable to provide the establishment and medical device registration they need to apply for a certificate of free sale to sell their products globally.
MDA has created a two-pronged strategy to address the gap in the medical device rules. Now, local manufacturers that work as OEMs can become licensed as manufacturers and register their devices under their own brands. The company then declares the “listed brand is the same as the registered medical device brand in terms of manufacturing processes, specifications and etc.”
The second pathway applies to OEM for non-owned brands. In this situation, MDA is proposing to license the companies through the authorized representative system, a mechanism that allows firms without a presence in Malaysia to operate in the market. The product registration uses a brand or medical device name and is exempt from certain requirements.
MDA brought the changes in with immediate effect.
MDA Circular
India, Iran Agree to Regulatory Cooperation, Exchange of Information
The Indian government has signed off on a healthcare regulation cooperation agreement with Iran. The memorandum of understanding is intended to tighten bilateral ties between the countries.
Among the points covered by the memorandum is a commitment to cooperate on the regulation of pharmaceuticals and medical devices. This will entail the exchange of information between India and Iran.
The details of how the regulatory commitment and other aspects of the agreement are realized will be dictated by a working group. Members of the working group will flesh out the terms of the cooperation and oversee its implementation.
The memorandum is the latest in a string of similar agreements formed by India over the past six months. In that time, India has allied with Cuba, Italy and Morocco on the regulation of medicines and devices.
Press Release
New DCGI Schedules Quarterly Meetings with Pharma Trade Groups
The newly appointed Drug Controller General of India (DCGI) has agreed to meet with pharma trade groups every quarter. The meetings will give the trade groups the opportunity to discuss matters related to their interactions with the Central Drugs Standard Control Organization (CDSCO).
Arun Sharma, CDSCO’s administrative director, has invited five pharmaceutical trade groups and one small business organization to send two representatives each to the meetings. The groups may also be allowed to send subject matter experts if they seek permission from CDSCO before the meetings.
The scheduling of the quarterly meetings comes one month after S. Eswara Reddy replaced GN Singh as DCGI. Under the new policy, the trade groups will have more regular, formal access to DCGI to talk about regulatory issues affecting their members.
Other News:
Biogen is withdrawing its multiple sclerosis drug Zinbryta from the Australian market. The Therapeutic Goods Administration (TGA) disclosed the action after holding talks with Biogen about the inflammatory brain disorder adverse events that led to the withdrawal of the product in Europe. TGA has not received reports of such events affecting patients in Australia. Biogen will continue to supply the drug until the end of May to give patients time to transition to other products. TGA Notice
DCGI Reddy has told drug inspectors in India to monitor the movement of two batches of a typhoid vaccine manufactured by Biomed. The recently appointed DCGI issued the notice about the Peda Typh vaccine after tests found samples from the batches to be not of standard quality. The finding related to the Vi polysaccharide content of the vaccines. DCGI Notice
A subcommittee set up to review 344 banned fixed-dose combinations (FDCs) has asked All India Drugs Action Network (AIDAN) to submit information to support its assessment. The subcommittee wants AIDAN to opine on the therapeutic value and potential risks of the FDCs. Committee Notice


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