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INDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES

On October 18th, 2019 the Ministry of Health and Family Welfare published a draft of the Medical Device Rules, 2019 as a proposed amendment to the Medical Device Rules, 2017 requiring the registration of all non-Notified medical devices over a 42-month period with the Central Drugs Standard Control Organization (CDSCO). These Medical Device Rules, 2019 will come into full effect after being approved and published in the official gazette. The draft notification allows 30 days from 18 October 2019 for public comment and stakeholder feedback.

The plan calls for an 18-month voluntary registration period after which all class A and B devices would have 16 months to be registered (i.e., by Sep 17, 2022) in the CDSCO’s on-line portal. Class C and D devices would have 24 months to meet the same requirement (i.e., by May 17, 2023).

The registration application involves administrative documents such a Free Sales Certificate from the country of origin, ISO 13485 certificate, as well as basic product information. The registration process carries no government processing fees and do not expire, but may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by the requirement for an Import License (upon Notification). Once registered the local license holder will be required to notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SEA) occurring in India. 

Further, the registration process will generate a registration number which the importer must mention on the label of the medical device prior to placing the devices on the market (i.e., after Customs clearance).

Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate.

Asia Actual is available to answer questions or help register your devices when the new requirements take effect. Contact us to arrange an initial conversation.

THAI FDA ADDS ‘CONCISE EVALUATION’ FOR QUALIFYING MEDICAL AND IVD DEVICES

The Thai FDA has amended the Medical Device Act, 2009, and Medical Device Ordinance, 2018 (as amended) to add a Concise Evaluation option for qualifying Notified and Licensed medical and IVD devices. The new evaluation process eliminates the requirement for a Fee Sales Certificate / Certificate to Foreign Government issued from the country of origin. Guidance was published on September 30, 2019 with immediate effect. 

QUALIFICATION

To qualify for Concise Evaluation, a medical device must be registered (through full evaluation) and marketed for more than one year without any serious adverse events in 2 of 5 reference markets listed below; or in 1 of the markets for at least three years.

  1. Australia: Therapeutic Good Administration (TGA)
  2. Canada: Health Canada (HC)
  3. European Union:  Notified Body (EU NB)
  4. Japan: Japan Ministry of Health, Labour and Welfare (MHLW)
  5. USA: Food and Drug Administration (FDA)
NEW DOCUMENT LIST

In addition to the same documents required for a Full Evaluation, the following additional documents are required for the Concise Evaluation:

  1. Market Approval from regulatory authority in reference countries
  2. Marketing History Declaration
  3. Manufacturer Safety Declaration to confirm no reported deaths, serious deterioration in the state of health, open field safety corrective actions (recalls) at the point of submission of the application
  4. Declaration Letter that Device Quality; intended use, indication packaging, labeling, instructions for use for supply in Thailand are identical as that approved by the reference agency.
  5. Letter of Certification conformity to Concise Evaluation

For IVD devices, the products must also be included on the World Health Organization’s (WHO) list of pre-qualified IVD products (list available here).

Asia Actual has a strong regulatory team in Bangkok to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.

4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.

Incorporate Asian Requirements into Product Testing

Conformance testing certificates are a common element of medical device registration applications. In most Asian regulatory systems, test reports used for US and European device registration are sufficient, with notable exceptions. South Korea and other markets require CB Scheme certification for electrical safety testing certificates. Further, testing records should be generated based on a country’s electrical supply (e.g., 220V/60Hz and/or 380V/60Hz). In Indonesia, Certificates of Analysis require numeric test values as well as a pass/fail designation. In China, in addition to having a complete set of test certificates to international standards, registration of Class II and III devices will require test certificates generated from one of ten local CFDA-certified test laboratories.

Design Your Clinical Trial to include Asian Requirements

If you must conduct a clinical trial in support of FDA Approval or CE Marking, confirm the data generated will also be acceptable for device registration in Asia. The Pharmaceutical and Medical Devices Agency in Japan offers a Clinical Trial Consultation just for this purpose. You may also consider the Harmonization by Doing program in Japan, which is designed to reduce the cost and time to register novel devices significantly by shifting 25% of your patient sample from a US clinical trial to Japan. The Central Drugs Standard Control Organization (CDSCO) in India will generally accept clinical data from outside India (except for drug-eluting stents, etc.), but may want to see ethnicity data. Again, Chinese registration of Class II and III devices will require a limited local clinical trial data.

Select a Fully Recognized Notified Body

Pick an ISO 13485 Registrar and CE Mark Notified Body that is recognized by competent authorities in Asia to avoid redundant QMS inspections and product conformity assessment fees.

Examples:
    • The Australian government has a mutual recognition treaty with the European Union whereby medical devices with CE Mark avoid local conformity assessment, greatly accelerating market listing in Australia. However, the Australian government has begun to deny recognition of certain Notified Bodies.
    • In Japan, if your device qualifies for Pre-Market Certification (most Class II and some Class III devices), conformity assessment will be performed by a private Registered Certification Body. Seven of the fourteen RCBs also provide CE Mark in Europe.
    • In Korea, a similar situation applies to most Class II devices.
    • In Malaysia’s new and evolving regulatory system, all devices must undergo local conformity assessment, though the assessment for devices with reference country approval is greatly expedited. In these cases, manufacturers may request synergies if their Notified Body is also their RCB in Japan or Third Party Reviewer in Malaysia and South Korea.

Budget to Control Your Registration Certificate in Asia

In the US, Europe and Canada, the manufacturer on the labeling is considered the owner of the product registration certificate. In all other regulatory systems, the license/certificate/listing is owned or fully controlled by a local agent. In these markets, foreign manufacturers can only change or add distributors with the cooperation of the incumbent license holder. If the license is held by a commercial distribution partner, it is difficult to add, change or influence distributors in that market. Also, start-up companies with acquisition strategies have added incentive to control registration certificates to enhance acquisition value and enable the acquiring company to integrate new device/s into its direct sales channel. This situation can only be assured through an independent license holder.

Contact Asia Actual for specific conditions that apply to your devices in Asia.

THAILAND ELEVATES REGULATORY STATUS OF DERMAL FILLERS

With Special Announcement No. 136 the Thai FDA increased the regulatory status of Hyaluronic Acid-based dermal fillers from Notified to Licensed (Class 4). This change will effectively increase the cost and time required to obtain an Import License for these devices under the current regulations.

This change was announced on September 13, 2019 and goes into effect 180 days later (on March 11, 2020). Products covered by an existing Import License will retain market access until expiry. All new or renewal applications are subject to the new requirements.

GOVERNMENT PROCESSING FEES
Class 1THB 25,000 (US$740)
Class 2THB 38,000 (US$1,120)
Class 3THB 63,000 (US$1850)
Class 4THB 88,000 (US$2,590)


CLASS I “LICENSED” MEDICAL DEVICES

1 YEAR PROCESSING TIME

  • Condoms
  • Gloves, surgical and exam
  • Syringes
  • HIV test kits
  • Contact lens (corrective and cosmetic)
  • Injective Hyaluronic for defective skin (09/13/2019)

CLASS II “NOTIFIED” MEDICAL DEVICES 

6-8 MONTHS PROCESSING TIME

  • Physical therapy equipment
  • Alcohol detectors
  • Methamphetamine Detectors
  • Breast implants
  • Opthalmic Viscoelastic Device
  • Concentrate for haemodialysis (10/03/2017)
  • Alcohol based sterilizer (09/13/2019)
  • Alcohol gel sanitizer (09/13/2019)
  • Teeth whitening devices (Hydrogen peroxide 6% +, fluorite 0.11% +) (09/25/2018)
  • Intense Pulsed Light (IPL) devices (pending)
  • Automatic External Defibrillators (AED) (pending)
  • Syphilis Screening Tests (pending)

CLASS III “GENERAL” MEDICAL DEVICE

2 TO 6 DAYS PROCESSING TIME (TYPICAL)

  • All other medical devices
  • Including dental equipment

Contact Asia Actual for more information regarding regulatory changes in Thailand

THAILAND NOTIFIES ALCOHOL-BASED STERILIZATION PRODUCTS

With Special Announcement No. 136 the Thai FDA increased the regulatory status of alcohol-based sterilization devices from General to Class 2 Notified. This change will effectively increase the cost and time required to obtain an Import License for these devices under the current regulations.

This change was announced on September 13, 2019 for immediate effect. Products covered by an existing Import License will retain market access until its expiry. All new or renewal applications are subject to the new requirements.

The requirements apply to devices intended for sterilization of human or animal skin or medical formulated from ethyl alcohol or ethanol (minimum of 70% by volume). Government processing fees will depend on device classification as per the table below. Processing times are targeted at 6 months.

Class 1THB 25,000 (US$740)
Class 2THB 38,000 (US$1,120)
Class 3THB 63,000 (US$1850)
Class 4THB 88,000 (US$2,590)

Contact Asia Actual for more information regarding regulatory changes in Thailand