Posts

DON’T PLAY ROULETTE WITH YOUR RUSSIAN TEST REPORTS

Considering the complexity of the importing test samples and the risk of test laboratories losing accreditation, it is important for manufacturers seeking medical or diagnostic device registration in Russia work with an experienced, local partner who can make an informed selection of test laboratories and take fast corrective action should the selected lab be affected.

INDIA OFFICIALLY REQUIRES REGISTRATION OF ALL NON-NOTIFIED DEVICES

On February 11th, 2020 the Ministry of Health and Family Welfare published the Medical Device Rules, 2020 as an amendment to the Medical Device Rules

HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION

Hong Kong’s Department of Health officially changed the name of the Medical Device Control Office (MDCO) to the Medical Device Division (MDD) at the end of 2019.

THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS

With Regulation B.E. 2562 (revision from regulation B.E. 2540), the Thai FDA increased the regulatory status of breast implants from Notified to Licensed (Class 4)

PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS

New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.

CHINA AMENDS MEDICAL DEVICE APPLICATION SUBMISSION PROCESS

In an ongoing effort to refine and improve the systems and procedures for medical device registration in China, the National Medical Products Administration or NMPA (previously the CFDA) moved to a new on-line submission system and harmonized the applications table of contents to international standards.

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.