Asia is emerging from the global recession faster than other regions in the world. This article goes through some of the major regulatory updates in various Asian countries.
Government Agency Changes
India’s government is working on a comprehensive regulatory framework for the medical device sector, which lacks a formal regulatory system. Currently, medical devices are often either regulated as drugs or unregulated. Now, however, India’s health authorities plan to issue a new set of guidelines to define and regulate medical devices as a separate category. These guidelines are being finalized in consultation with the device industry and should be issued by the health ministry soon.
The new guidelines primarily separate medical devices from drugs. They call for stricter oversight from the Drug Controller General of India (DCGI) of the Central Drugs Standards Control Organization (CDSCO) of both the manufacture and import of medical devices. The CDSCO currently has a separate branch to deal with medical device applications and monitoring. However, this branch will need to expand after the publication of the medical device regulatory framework. In addition, CDSCO will be upping its regulatory manpower by hiring 62 new drug/device inspectors and 10 new technical officers.
Also, the bill for the creation of a Central Drugs Authority is underway. This authority would be an autonomous organization under the Ministry of Health & Family Welfare. Currently, CDSCO works with India’s 35 state-level food and drug administrations to regulate medical products. By establishing this new Central Drugs Authority, the government aims to have more uniform, centralized medical product licensing and enforcement while improving drug quality and safety.
These initiatives demonstrate that CDSCO is prepared to improve the oversight of medical devices and drugs distributed to the Indian public.
Under the Food and Drugs Administration Act of 2009, the new Filipino FDA (formerly the Bureau of Food and Drugs) has expanded authority and increased regulatory capacity. The act makes it easier for the Philippine government to make medicines affordable. It also makes medicines more accessible to the public and guarantees their efficacy, high quality and safety. This legislation complements the Universally Accessible Cheaper and Quality Medicines Act of 2008.
The Filipino FDA was given the power to immediately recall, ban or withdraw medical products that fail to meet safety standards or are found to pose a threat to the public. In addition, the agency is authorized to inspect facilities for compliance and seize products that have safety issues. The Filipino FDA was given fiscal independence to hire new personnel, upgrade laboratory facilities and purchase necessary testing equipment. These expenditures do not require government approval.
To streamline the regulation of manufacture, import, export, distribution and sale of major product types, there will be separate FDA centers for drug regulation and research, device regulation, radiation, health and research.
The Korea Food and Drug Administration (KFDA) is undergoing reorganization. In his second year as commissioner, Yun Yeo-pyo has decided to restructure KFDA to improve its efficiency and oversight of food, drug and medical device safety.
New KFDA divisions will include a Risk Prevention Policy Bureau and a Risk Violation Central Investigation Agency. The Risk Prevention Policy Bureau, with a planned staff of 45, will focus on preventing incidents. The Risk Violation Central Investigation Agency will strengthen postmarket surveillance and response. This agency will conduct criminal investigations of manufacturers that undertake illegal and unsafe practices in food, drug and medical device production or distribution. It will have the authority to penalize such manufacturers. The new agency will have about 80 employees, including 20 stationed at KFDA headquarters and 10 at each of six branch offices.
In addition, several functions previously handled by KFDA headquarters personnel, including GMP evaluation, will be transferred to the branch offices so headquarters can concentrate on policy and safety. The branch offices will be restructured to execute these tasks and their simpler duties will then be transferred to local governments.
Standards for employee hiring and promotion have also been raised, and a budget of 2.9 billion won (approximately $2.1 million (US)) was approved for personnel management. This budget will allow KFDA to hire about 40 new professionals, which should improve registration efficiency and shorten review times.
Thailand’s Medical Device Act went into effect in 2008, overhauling the regulatory system for devices. The Thai Food and Drug Administration (FDA) recently implemented a new phase of this act, including the transfer of some regulatory powers to the provincial governments, which has been delayed.
Under the Medical Device Act, the 75 Provincial Public Health Offices have been granted various powers relating to the medical device business within their jurisdictions, including issuing and revoking medical device distribution licenses. They can also order the cancellation of medical device advertisements that do not comply with the Medical Device Act. The Provincial Public Health Offices work under national guidelines in consultation with Thai FDA.
This limited transfer of powers is intended to reduce regulatory costs to the medical device industry in Thailand, since it means medical device companies and branch offices outside Bangkok do not need to travel there as often. However, it could also pose problems if the Provincial Public Health Offices have a lower level of expertise than Thai FDA.
Thai FDA has stated that the Medical Device Act’s rules on advertising will be strictly enforced and will apply to anyone promoting a medical device to encourage a sale, even if the party is not actually selling the device. Therefore, international medical device firms that promote their products in Thailand without actually distributing them (e.g., through representative offices) should also be familiar with the new law’s requirements, and be prepared to interact with Thai Provincial Public Health Offices.
New Product Registration Requirements
Japan is constantly focusing on expediting the medical device review process. Plans include hiring more medical device reviewers, providing them with extensive training, tracking their performance and publishing review times for approvals.
In addition, there will be a new, three-track review system for medical devices. The tracks will be for a new device (shin), improved device (kairyo) and “me-too” device (kohatsu). An improved device’s differences compared to the predicate device can be evaluated by nonclinical data. A me-too device is substantially equivalent to an approved medical device in structure, usage method, indication, effect and performance, and any differences from the predicate device have no impact on efficacy or safety. The Pharmaceuticals and Medical Devices Agency (PMDA) will dedicate teams for reviewing kairyo and kohatsu applications.
PMDA is also planning to implement third-party certification for all Class II medical devices by 2011. Currently, about 50% of Class II medical devices are designated for third-party ninsho certification.
The DCGI has recently placed 19 additional medical devices under the regulation of the Drugs and Cosmetics Act (DCA). Devices that now require a license for distribution and sale include: spinal needles, insulin syringes, endotracheal tubes, cochlear implants, annuloplasty rings, trachestomy tubes, heart lung packs, measure volume sets, hemodialysis tubing sets, blood tubing sets and dialysis catheters.
CDSCO has updated Schedule MIII of the DCA for medical devices. The proposed draft guidance documents are similar to Global Harmonization Task Force (GHTF) guidelines regarding definition, classification and labeling requirements. Medical device classifications are based on risk, where Class A is low risk and Class D is high risk.
The conformity assessment for Class A medical devices will be carried out by the manufacturer. A manufacturing license is not required from the Central Licensing Authority (CLAA), but the manufacturer must register with the authority.
The quality management system (QMS) for Class B medical devices needs to be certified by a Notified Body (NB). CLAA will issue a No Objection Certificate (NOC) to the manufacturer based on the assessment by the NB.
Class C medical devices will require certification by an NB regarding design and manufacture. The manufacturer will be required to apply for a license and supply supporting documents with respect to a device’s safety and effectiveness.
Likewise, Class D medical devices will require certification by an NB regarding design and manufacture and the manufacturer will also be required to apply for a license, supplying supportive documents with respect to device safety and effectiveness. In addition, an inspection of the manufacturing site will be required by CLAA and the state licensing authority.
The Health Products Act was enacted in 2007 and is currently being implemented. As a result, foreign medical device manufacturers are now required to import their products via a firm that holds an import license and apply for device licenses prior to distribution. For high- and medium-risk devices (Class B, C and D), licenses will be required by 1 May 2010. Licenses received after 1 February 2010 may not be processed in time. For low-risk devices (Class A), the deadline is 1 May 2011.
The first phase—from November 2007 to November 2008—required that adverse events and recalls be reported to the Health Sciences Authority (HSA) of Singapore. This first phase also prohibited any false and misleading labeling. The second phase—which extends from November 2008 to May 2010—calls for licensing of manufacturers and distributors and registration of medical devices. In other words, manufacturers and distributors need to apply for appropriate business and medical device licenses. The third phase will extend from May 2010 onwards, and will require licenses to sell, manufacture and distribute most medical devices.
Class A devices will have an HSA-specific application process, but Class B, C and D device applications will use the ASEAN Common Technical Dossier format. The product evaluation may be abridged or full: abridged applications apply to medical devices that have been evaluated and approved by at least one of the five reference agencies, i.e., US FDA, EU NB, Health Canada, Australia TGA and Japan Ministry of Health, Labour and Welfare. Also, all aspects of device quality including packaging, labeling, instructions for use, etc., must be the same as those approved by the reference agency.
Because this is a transitional period, there is an opportunity for a presubmission consultation with HSA. One consultation to identify gaps or discrepancies in the preparation of the medical device dossier in the CTD format can be requested. Applicants must submit the dossier one month before the consultation. Also, applicants can submit inquiries to HSA to get a written response on issues such as device classification. A written response will be binding. Annual renewal for product registration will be required.
China’s State Food and Drug Administration (SFDA) has revised the provisions on medical device registration this year. The revised Provisions emphasize legal responsibilities of manufacturers and intensify the punishments for illegal activities. Manufacturers that provide false application materials such as fake certificates, documents and product samples will be punished by the relevant SFDA department. Consequences may include denial of registration applications, refusal to grant registration certificates or fines.
In addition, applicants seeking medical device registration should conduct research and a risk analysis, verifying quality control and the device’s safety and effectiveness. They will also need to submit reports on technical functionality and performance and risk management, as well as a self-assessment report on the quality management system. Public comments were solicited in May 2009.
Adverse Events and Postmarket Surveillance
Schedule M III guidelines for medical devices are now posted on the CDSCO website. Medical facilities around India must now have a pharmacovigilance center.
Currently, there are no device-specific adverse event reporting forms. Medical device adverse events are reported using the Schedule Y requirements specified in the Drugs and Cosmetics Act.
There have been proposals to require adverse event reports to include all available information in a universal dataset. In addition, the manufacturer would systematically monitor the performance of the device during use (postmarketsurveillance). Appropriate corrective and preventive actions would be applied to prevent the recurrence of adverse events.
In February 2009, Thailand’s Liability for Damages Arising from Unsafe Products Act took effect. Liability for unsafe products changes drastically with this new law, and drug and device manufacturers selling products in Thailand need to be aware of the changes in the legal system.
The act states that a consumer has only to demonstrate harm caused by a medical product’s normal use or storage to be able to collect damages. Also, everyone involved in the sale or import of the medical product, including the manufacturer and distributor, is jointly liable for damages. If they are found guilty of gross negligence or marketing unsafe products while aware of their danger, responsible parties may be ordered to pay punitive damages in addition to compensation for physical and mental damage. A contract or waiver signed before damages occur does not limit the manufacturer or distributor’s liability.
In order to be found not guilty, the manufacturer and/or distributor must prove that: the product was not unsafe; the damaged party was aware that the product was unsafe, yet used it regardless; or the damage was a result of inappropriate product use or storage, clearly counter to the labeling or packaging instructions.
Quality Assurance and Good Manufacturing Practice (GMP)
Medical devices manufactured in India should, as a general rule, bear the Indian Conformity Assessment Certificate (ICAC) mark. Each device class should follow respective procedures for affixing the ICAC mark given in the proposed Schedule MIII..
The manufacturer and/or NB will verify the results to ensure the conformity assessment has been carried out in accordance with the proposed schedule. The NB may require, where duly justified, any information or data necessary for establishing and maintaining proof of conformity under the chosen procedure.
Conformity assessment procedures, as per GHTF Guideline SG1-N40:2006. have now been recommended. This includes ICAC conformity assessment procedure where ICAC is mandatory for devices to be sold in India. A declaration of conformity also would be issued on satisfactory assessment of QMS procedures. Class-based conformity assessment procedures have been laid down with varying design and development verification procedures. For example, Class A medical devices (low risk) would be exempt from design and development procedures.
To guarantee impartiality, an NB cannot be a designer, manufacturer, supplier, installer or user of the medical device. The manufacturer must notify CLAA of the accredited NB it has designated to carry out the conformity assessment. NBs must share all required information with CLAA and must have civil liability insurance.
SFDA is contemplating new regulations stipulating preapproval QMS inspections on a device-by-device basis. The US noted that this can be a resource-intensive and inefficient process, suggesting that a QMS should be qualified based on the manufacturing facility, not specific products. Therefore, all registration applications from that manufacturer’s facility would be qualified regarding QMS.
SFDA is continuing to ramp up plans to improve quality and increase regulations in the medical device area. After setting up a trial Good Manufacturing Practice (GMP) scheme for sterile and implantable medical devices, SFDA issued Regulations for Medical Device Manufacturing and Quality Control and Inspection Methods to Regulations for Medical Device Manufacturing and Quality Control for public comment in 2008. These draft GMP regulations propose on-site inspections for companies registering their medical device for the first time or for re-registration. In addition, if there are changes to the manufacturing license, the manufacturing site or the manufacturing scope, SFDA would conduct an on-site audit. A medical device company would also need to submit documents such as its business license, medical device manufacturing license, a corporate organizational chart, etc. for the agency to review. After SFDA review, GMP inspectors would audit the facility and SFDA would review the audit report.
Most likely, these GMP regulations will be revised and become mandatory in 2010 or 2011. As of now, there is no official announcement on a target date.
Ames Gross is the president and founder of Pacific Bridge Medical. He is recognized nationally and internationally as a leader in Asian medical markets.
Momoko Hirose is a vice president at Pacific Bridge Medical. She works on consulting projects and research.